Covid 19 Research using Clinical Trials (Home Page)
OntamalimabWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2443 | Tap water Wiki | 0.50 |
| drug870 | Essential oils Wiki | 0.50 |
| drug866 | Equipment with smartwatch throughout hospital stay on the general ward Wiki | 0.50 |
| drug1883 | Povidone-Iodine Wiki | 0.25 |
| drug1822 | Placebo Wiki | 0.11 |
Correlated MeSH Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003424 | Crohn Disease NIH | 0.50 |
| D014456 | Ulcer NIH | 0.41 |
| D003092 | Colitis NIH | 0.41 |
| D003093 | Colitis, Ulcerative NIH | 0.41 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100280 | Crohn's disease HPO | 0.50 |
| HP:0002583 | Colitis HPO | 0.41 |
| HP:0100279 | Ulcerative colitis HPO | 0.41 |
There are 4 clinical trials
Clinical Trials
1 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
NCT03259308 Ulcerative Colitis Drug: Ontamalimab Drug: Placebo MeSH:Colitis Colitis, Ulcerative Ulcer
HPO:Colitis Ulcerative colitis
Primary Outcomes
Description: Remission is defined as a composite score of patient-reported symptoms using daily ediary and centrally read endoscopy as stool frequency subscore of 0 or 1 with at least a 1-point change from baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability). The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); Physician global assessment (PGA: 0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Remission at Week 12 Time: Week 12
Secondary Outcomes
Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Endoscopic Remission at Week 12 Time: Week 12
Description: Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0. The stool frequency subscore and rectal bleeding subscore range from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Clinical Remission at Week 4, 8, 12 Time: Week 4, 8, 12
Description: Clinical response (composite) is defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1. The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Response (Composite) at Week 12 Time: Week 12
Description: Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Mucosal Healing at Week 12 Time: Week 12
Description: Remission is defined as a total mayo score of less than or equal to <=2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and PGA) exceeding 1, at the Week 12. The total mayo score ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Remission Based on Total Mayo Score at Week 12 Time: Week 12
Description: Clinical response (Mayo) is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding >=1 point or an absolute subscore for rectal bleeding <=1. The total mayo score ranges from 0 to 12 points and consists of the following 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12 Time: Week 12
Description: The partial mayo score ranges from 0 to 9 points and consists of the following 3 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score does not include the endoscopy subscore. Here participants with partial Mayo score <= 2 with no individual subscore >1 at the Week 4, 8, and 12 will be assessed.
Measure: Number of Participants With Partial Mayo Score Less than or Equal to (<=) 2 with no Individual Subscore Greater than (>) 1 at Week 4, 8, 12 Time: Week 4, 8, 12
Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Here number of participants with endoscopic remission at week 12 with a subscore of 0 will be assessed.
Measure: Number of Participants with Endoscopic Remission at Week 12 With Endoscopic Subscore of 0 Time: Week 12
Description: Clinical remission with both rectal bleeding and stool frequency subscores of 0 at week 4, 8, 12 will be assessed. The stool frequency subscore and rectal bleeding subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Subscores of 0 at Week 4, 8, 12 Time: Week 4, 8, 12
Description: Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.. The stool frequency subscore, rectal bleeding subscore and endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Deep Remission at Week 12 Time: Week 12
Description: Participants will be asked to record the abdominal pain worst severity using 0-10 numeric rating scale, with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Abdominal Pain Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: Participants will be asked to record the diarrhea frequency (enter number of loose or watery bowel movements) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Diarrhea Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: Participants will be asked to record the urgency frequency (enter number of bowel movements with urgency) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Urgency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: Participants will be asked to record the stool frequency (enter number of bowel movements passed) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Stool Frequency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: Participants will be asked to record the rectal bleeding severity and frequency (enter number of bowel movements with blood) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Rectal Bleeding Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: The total sign/symptom score (average of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) ranges from 0 to 10 with higher scores indicating higher severity.
Measure: Change From Baseline Total Sign/Symptom Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: The IBDQ is a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 8, 12 Time: Baseline, Week 8, 12
Description: The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores and Individual Domain Scores) at Week 12 Time: Baseline, Week 12
Description: Incidence of hospitalizations during the entire study period will be assessed.
Measure: Incidence of Hospitalizations Time: From start of study up to follow up (Week 29)
Description: Incidence of total inpatient days during the entire study period will be assessed.
Measure: Incidence of Total Inpatient Days Time: From start of study up to follow up (Week 29)
2 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)
Primary Outcomes
Description: Remission is defined as a composite score of patient-reported symptoms using daily ediary and centrally read endoscopy as stool frequency subscore of 0 or 1 with at least a 1-point change from baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability). The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); Physician global assessment (PGA: 0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Remission at Week 12 Time: Week 12Secondary Outcomes
Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Endoscopic Remission at Week 12 Time: Week 12Description: Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0. The stool frequency subscore and rectal bleeding subscore range from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Clinical Remission at Week 4, 8, 12 Time: Week 4, 8, 12Description: Clinical response (composite) is defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1. The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Response (Composite) at Week 12 Time: Week 12Description: Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Mucosal Healing at Week 12 Time: Week 12Description: Remission is defined as a total mayo score of less than or equal to <=2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and PGA) exceeding 1, at the Week 12. The total mayo score ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Remission Based on Total Mayo Score at Week 12 Time: Week 12Description: Clinical response (Mayo) is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding >=1 point or an absolute subscore for rectal bleeding <=1. The total mayo score ranges from 0 to 12 points and consists of the following 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12 Time: Week 12Description: The partial mayo score ranges from 0 to 9 points and consists of the following 3 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score does not include the endoscopy subscore. Here participants with partial Mayo score <= 2 with no individual subscore >1 at the Week 4, 8, and 12 will be assessed.
Measure: Number of Participants With Partial Mayo Score Less than or Equal to (<=) 2 with no Individual Subscore Greater than (>) 1 at Week 4, 8, 12 Time: Week 4, 8, 12Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Here number of participants with endoscopic remission at week 12 with a subscore of 0 will be assessed.
Measure: Number of Participants with Endoscopic Remission at Week 12 With Endoscopic Subscore of 0 Time: Week 12Description: Clinical remission with both rectal bleeding and stool frequency subscores of 0 at week 4, 8, 12 will be assessed. The stool frequency subscore and rectal bleeding subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Subscores of 0 at Week 4, 8, 12 Time: Week 4, 8, 12Description: Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.. The stool frequency subscore, rectal bleeding subscore and endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Deep Remission at Week 12 Time: Week 12Description: Participants will be asked to record the abdominal pain worst severity using 0-10 numeric rating scale, with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Abdominal Pain Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the diarrhea frequency (enter number of loose or watery bowel movements) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Diarrhea Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the urgency frequency (enter number of bowel movements with urgency) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Urgency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the stool frequency (enter number of bowel movements passed) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Stool Frequency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the rectal bleeding severity and frequency (enter number of bowel movements with blood) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Rectal Bleeding Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: The total sign/symptom score (average of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) ranges from 0 to 10 with higher scores indicating higher severity.
Measure: Change From Baseline Total Sign/Symptom Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: The IBDQ is a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 8, 12 Time: Baseline, Week 8, 12Description: The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores and Individual Domain Scores) at Week 12 Time: Baseline, Week 12Description: Incidence of hospitalizations during the entire study period will be assessed.
Measure: Incidence of Hospitalizations Time: From start of study up to follow up (Week 29)Description: Incidence of total inpatient days during the entire study period will be assessed.
Measure: Incidence of Total Inpatient Days Time: From start of study up to follow up (Week 29)The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
NCT03259334 Ulcerative Colitis Drug: Ontamalimab Other: Placebo MeSH:Colitis Colitis, Ulcerative Ulcer
HPO:Colitis Ulcerative colitis
Primary Outcomes
Description: Remission is defined as a composite score of participant-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency subscore of 0 or 1 with at least a 1-point change from baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability). The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); Physician global assessment (PGA: 0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Remission at Week 12 Time: Week 12
Secondary Outcomes
Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Endoscopic Remission at Week 12 Time: Week 12
Description: Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0. The stool frequency subscore and rectal bleeding subscore range from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Clinical Remission at Week 4, 8, 12 Time: Week 4, 8, 12
Description: Clinical response (composite) is defined as a decrease from baseline in the composite score of participant-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1. The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Response (Composite) at Week 12 Time: Week 12
Description: Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Mucosal Healing at Week 12 Time: Week 12
Description: Remission is defined as a total mayo score of less than or equal to <=2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1, at the Week 12. The total mayo score ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Remission Based on Total Mayo Score at Week 12 Time: Week 12
Description: Clinical response (Mayo) is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding >=1 point or an absolute subscore for rectal bleeding <=1. The total mayo score ranges from 0 to 12 points and consists of the following 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12 Time: Week 12
Description: The partial mayo score ranges from 0 to 9 points and consists of the following 3 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score does not include the endoscopy subscore. Number of participants with partial mayo score <=2 with no individual subscore >1 at the Week 4, 8, 12 will be assessed.
Measure: Number of Participants With Partial Mayo Score Less than or Equal (<=) 2 with no individual subscore Greater than (>) 1 at Week 4, 8, 12 Time: Week 4, 8, 12
Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Here number of participants with endoscopic remission at week 12 with a subscore of 0 will be assessed.
Measure: Number of Participants with Endoscopic Remission at Week 12 With Endoscopic Subscore of 0 Time: Week 12
Description: Clinical remission with both rectal bleeding and stool frequency subscores of 0 at week 4, 8, 12 will be assessed. The stool frequency subscore and rectal bleeding subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Subscores of 0 at Week 4, 8, 12 Time: Week 4, 8, 12
Description: Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.. The stool frequency subscore, rectal bleeding subscore and endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Deep Remission at Week 12 Time: Week 12
Description: Participants will be asked to record the abdominal pain worst severity using 0-10 numeric rating scale, with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Abdominal Pain Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: Participants will be asked to record the diarrhea frequency (enter number of loose or watery bowel movements) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Diarrhea Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: Participants will be asked to record the urgency frequency (enter number of bowel movements with urgency) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Urgency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: Participants will be asked to record the stool frequency (enter number of bowel movements passed) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Stool Frequency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: Participants will be asked to record the rectal bleeding severity and frequency (enter number of bowel movements with blood) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Rectal Bleeding Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: The total sign/symptom score (average of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) ranges from 0 to 10 with higher scores indicating higher severity.
Measure: Change From Baseline Total Sign/Symptom Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12
Description: The IBDQ is a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 8, 12 Time: Baseline, Week 8, 12
Description: The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores and Individual Domain Scores) at Week 12 Time: Baseline, Week 12
Description: Incidence of hospitalizations during the entire study period will be assessed.
Measure: Incidence of Hospitalizations Time: From start of study up to follow up (Week 29)
Description: Incidence of total inpatient days during the entire study period will be assessed.
Measure: Incidence of Total Inpatient Days Time: From start of study up to follow up (Week 29)
3 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)
Primary Outcomes
Description: Remission is defined as a composite score of participant-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency subscore of 0 or 1 with at least a 1-point change from baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability). The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); Physician global assessment (PGA: 0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Remission at Week 12 Time: Week 12Secondary Outcomes
Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Endoscopic Remission at Week 12 Time: Week 12Description: Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0. The stool frequency subscore and rectal bleeding subscore range from 0 to 3 with higher scores indicating more severe disease.
Measure: Number of Participants With Clinical Remission at Week 4, 8, 12 Time: Week 4, 8, 12Description: Clinical response (composite) is defined as a decrease from baseline in the composite score of participant-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1. The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Response (Composite) at Week 12 Time: Week 12Description: Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Mucosal Healing at Week 12 Time: Week 12Description: Remission is defined as a total mayo score of less than or equal to <=2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1, at the Week 12. The total mayo score ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Remission Based on Total Mayo Score at Week 12 Time: Week 12Description: Clinical response (Mayo) is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding >=1 point or an absolute subscore for rectal bleeding <=1. The total mayo score ranges from 0 to 12 points and consists of the following 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).
Measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12 Time: Week 12Description: The partial mayo score ranges from 0 to 9 points and consists of the following 3 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score does not include the endoscopy subscore. Number of participants with partial mayo score <=2 with no individual subscore >1 at the Week 4, 8, 12 will be assessed.
Measure: Number of Participants With Partial Mayo Score Less than or Equal (<=) 2 with no individual subscore Greater than (>) 1 at Week 4, 8, 12 Time: Week 4, 8, 12Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Here number of participants with endoscopic remission at week 12 with a subscore of 0 will be assessed.
Measure: Number of Participants with Endoscopic Remission at Week 12 With Endoscopic Subscore of 0 Time: Week 12Description: Clinical remission with both rectal bleeding and stool frequency subscores of 0 at week 4, 8, 12 will be assessed. The stool frequency subscore and rectal bleeding subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.
Measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Subscores of 0 at Week 4, 8, 12 Time: Week 4, 8, 12Description: Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.. The stool frequency subscore, rectal bleeding subscore and endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.
Measure: Number of Participants With Deep Remission at Week 12 Time: Week 12Description: Participants will be asked to record the abdominal pain worst severity using 0-10 numeric rating scale, with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Abdominal Pain Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the diarrhea frequency (enter number of loose or watery bowel movements) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Diarrhea Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the urgency frequency (enter number of bowel movements with urgency) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Urgency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the stool frequency (enter number of bowel movements passed) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Stool Frequency Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: Participants will be asked to record the rectal bleeding severity and frequency (enter number of bowel movements with blood) as experienced over the previous 24 hours, in the e-diary.
Measure: Change From Baseline in Absolute Rectal Bleeding Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: The total sign/symptom score (average of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) ranges from 0 to 10 with higher scores indicating higher severity.
Measure: Change From Baseline Total Sign/Symptom Score Based on Participant e-Diary at Week 12 Time: Baseline, Week 12Description: The IBDQ is a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 8, 12 Time: Baseline, Week 8, 12Description: The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores and Individual Domain Scores) at Week 12 Time: Baseline, Week 12Description: Incidence of hospitalizations during the entire study period will be assessed.
Measure: Incidence of Hospitalizations Time: From start of study up to follow up (Week 29)Description: Incidence of total inpatient days during the entire study period will be assessed.
Measure: Incidence of Total Inpatient Days Time: From start of study up to follow up (Week 29)The purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
NCT03559517 Crohn's Disease Biological: Ontamalimab Other: Placebo MeSH:Crohn Disease
HPO:Crohn's disease
Primary Outcomes
Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission at Week 16 Time: Week 16
Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.
Measure: Number of Participants With Endoscopic Response at Week 16 Time: Week 16
Secondary Outcomes
Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.
Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16 Time: Week 16
Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.
Measure: Number of Participants With Enhanced Endoscopic Response at Week 16 Time: Week 16
Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16 Time: Week 16
Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.
Measure: Number of Participants With Clinical Response at Week 16 Time: Week 16
Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).
Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16 Time: Week 16
Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.
Measure: Number of Participants With Complete Endoscopic Healing at Week 16 Time: Week 16
Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16 Time: Week 16
Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16 Time: Week 16
Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission Over Time Time: Baseline up to Week 16
Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).
Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16 Time: Baseline, Week 16
Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.
Measure: Number of Participants With Endoscopic Healing at Week 16 Time: Week 16
Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score Time: Baseline, Week 8, Week 12, up to Week 16, or early termination
Description: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form (SF)-36 at Week 16 Time: Baseline, Week 16
Description: Incidence of all cause hospitalizations will be assessed.
Measure: Incidence of Hospitalizations Time: Baseline up to Week 32
Description: Incidence of total inpatient days will be assessed.
Measure: Incidence of Total Inpatient Days Time: Baseline up to Week 32
Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.
Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries Time: Baseline up to Week 32
4 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)
Primary Outcomes
Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission at Week 16 Time: Week 16Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.
Measure: Number of Participants With Endoscopic Response at Week 16 Time: Week 16Secondary Outcomes
Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.
Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16 Time: Week 16Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.
Measure: Number of Participants With Enhanced Endoscopic Response at Week 16 Time: Week 16Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16 Time: Week 16Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.
Measure: Number of Participants With Clinical Response at Week 16 Time: Week 16Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).
Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16 Time: Week 16Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.
Measure: Number of Participants With Complete Endoscopic Healing at Week 16 Time: Week 16Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16 Time: Week 16Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16 Time: Week 16Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission Over Time Time: Baseline up to Week 16Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).
Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16 Time: Baseline, Week 16Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.
Measure: Number of Participants With Endoscopic Healing at Week 16 Time: Week 16Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score Time: Baseline, Week 8, Week 12, up to Week 16, or early terminationDescription: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form (SF)-36 at Week 16 Time: Baseline, Week 16Description: Incidence of all cause hospitalizations will be assessed.
Measure: Incidence of Hospitalizations Time: Baseline up to Week 32Description: Incidence of total inpatient days will be assessed.
Measure: Incidence of Total Inpatient Days Time: Baseline up to Week 32Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.
Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries Time: Baseline up to Week 32The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
NCT03566823 Crohn's Disease Biological: Ontamalimab Other: Placebo MeSH:Crohn Disease
HPO:Crohn's disease
Primary Outcomes
Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission at Week 16 Time: Week 16
Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.
Measure: Number of Participants With Endoscopic Response at Week 16 Time: Week 16
Secondary Outcomes
Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.
Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16 Time: Week 16
Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.
Measure: Number of Participants With Enhanced Endoscopic Response at Week 16 Time: Week 16
Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16 Time: Week 16
Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.
Measure: Number of Participants With Clinical Response at Week 16 Time: Week 16
Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).
Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16 Time: Week 16
Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.
Measure: Number of Participants With Complete Endoscopic Healing at Week 16 Time: Week 16
Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16 Time: Week 16
Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16 Time: Week 16
Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission Over Time Time: Baseline up to Week 16
Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).
Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16 Time: Baseline, Week 16
Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.
Measure: Number of Participants With Endoscopic Healing at Week 16 Time: Week 16
Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score Time: Baseline, Week 8, Week 12, up to Week 16, or early termination
Description: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form (SF)-36 at Week 16 Time: Baseline, Week 16
Description: Incidence of all cause hospitalizations will be assessed.
Measure: Incidence of Hospitalizations Time: Baseline up to Week 32
Description: Incidence of total inpatient days will be assessed.
Measure: Incidence of Total Inpatient Days Time: Baseline up to Week 32
Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.
Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries Time: Baseline up to Week 32
Related HPO nodes (Using clinical trials)
HP:0002583: Colitis
Genes 43
TTC37 RFXANK SKIV2L PLCG2 MAP3K7 NLRC4 SKIV2L IL10RA BACH2 LRBA RFX5 TNFAIP3 STAT1 FOXP3 FAS RTEL1 FASLG IL6 ZAP70 RFXAP NOD2 TGFB1 IL10RB NCF4 CASP10 XIAP FAS PRKCD TCF4 MASP2 ZAP70 RET RASGRP1 FERMT1 POLA1 CIITA INAVA OPLAH GPR35 MST1 HPS1 CARMIL2 GPIHBP1 SNP 0
Primary Outcomes
Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission at Week 16 Time: Week 16Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.
Measure: Number of Participants With Endoscopic Response at Week 16 Time: Week 16Secondary Outcomes
Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.
Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16 Time: Week 16Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.
Measure: Number of Participants With Enhanced Endoscopic Response at Week 16 Time: Week 16Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16 Time: Week 16Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.
Measure: Number of Participants With Clinical Response at Week 16 Time: Week 16Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).
Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16 Time: Week 16Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.
Measure: Number of Participants With Complete Endoscopic Healing at Week 16 Time: Week 16Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16 Time: Week 16Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.
Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16 Time: Week 16Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.
Measure: Number of Participants With Clinical Remission Over Time Time: Baseline up to Week 16Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).
Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16 Time: Baseline, Week 16Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.
Measure: Number of Participants With Endoscopic Healing at Week 16 Time: Week 16Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life
Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score Time: Baseline, Week 8, Week 12, up to Week 16, or early terminationDescription: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.
Measure: Change From Baseline in Short Form (SF)-36 at Week 16 Time: Baseline, Week 16Description: Incidence of all cause hospitalizations will be assessed.
Measure: Incidence of Hospitalizations Time: Baseline up to Week 32Description: Incidence of total inpatient days will be assessed.
Measure: Incidence of Total Inpatient Days Time: Baseline up to Week 32Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.
Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries Time: Baseline up to Week 32