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Report for D003424: Crohn Disease NIH

(Synonyms: Crohn, Crohn Dis, Crohn Dise, Crohn Disease)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (8)


Name (Synonyms) Correlation
drug1844 Placebo for Upadacitinib Wiki 0.50
drug2097 Risankizumab SC Wiki 0.50
drug1843 Placebo for Risankizumab SC Wiki 0.50
drug2096 Risankizumab IV Wiki 0.50
drug1695 Ontamalimab Wiki 0.50
drug1842 Placebo for Risankizumab IV Wiki 0.50
drug2603 Upadacitinib Wiki 0.50
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0100280 Crohn's disease HPO 1.00

There are 4 clinical trials

Clinical Trials


1 A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

The study consists of 3 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991 - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.

NCT03105102 Crohn's Disease Drug: Placebo for Risankizumab SC Drug: Risankizumab IV Drug: Placebo for Risankizumab IV Drug: Risankizumab SC
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: Clinical remission per average daily stool frequency (SF) and average daily AP score.

Measure: Sub-Study 1: Percentage of Participants With Clinical Remission

Time: Week 52

Description: Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Sub-Study 1: Percentage of Participants With Endoscopic Response

Time: Week 52

Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Measure: Sub-Study 3: Number of Participants With Adverse Events

Time: Up to Week 220

Secondary Outcomes

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Time: Week 52

Description: Clinical remission per average daily SF and average daily AP score.

Measure: Sub-Study 1: Percentage of Participants With Clinical Remission Among Participants With Clinical Remission in Week 0

Time: Week 52

Description: Endoscopic healing was assessed using SES-CD.

Measure: Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy

Time: Week 52

Description: Endoscopic Remission is defined as SES-CD <= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer

Measure: Sub-Study 1: Percentage of Participants With Endoscopic Remission

Time: Week 52

Description: Response in IBDQ Bowel Symptom domain is defined as increase of IBDQ bowel symptom domain score >=8 from Baseline

Measure: Sub-Study 1: Mean Change From Baseline of Induction in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

Time: Week 52

Description: The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.

Measure: Sub-Study 1: Mean Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

Time: Week 52

Description: Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.

Measure: Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline

Time: Week 52

Description: The CDAI is used to evaluate disease activity in patients with Crohn's disease.

Measure: Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response

Time: Week 52

Description: Clinical remission per average daily SF and average daily AP score. Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Sub-Study 1: Percentage of Participants With Clinical Remission and Endoscopic Response

Time: Week 52

Description: Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.

Measure: Sub-Study 1: Percentage of Participants With Enhanced Clinical Response

Time: Week 52

Description: Deep remission defined as subjects with both clinical remission (per average daily SF and average daily AP score) and endoscopic healing (assessed using SES-CD).

Measure: Sub-Study 1: Percentage of Participants With Deep Remission

Time: Week 52

Description: Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

Measure: Sub-Study 1: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) in Participants With Any EIMs at Baseline of Induction

Time: Week 52

Description: Participants with an event that results in admission to the hospital.

Measure: Sub-Study 1: Percentage of Participants With CD-Related Hospitalizations

Time: Up to Week 52

Description: Participants without draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study.

Measure: Sub-Study 1: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline of Induction

Time: Week 52

Description: Participants who underwent surgery related to CD.

Measure: Sub-Study 1: Percentage of Participants With Crohn's Disease (CD)-Related Surgeries

Time: Up to Week 52

2 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

NCT03345823 Crohn's Disease Drug: Upadacitinib Drug: Placebo for Upadacitinib
MeSH:Crohn Disease
HPO:Crohn's disease

Primary Outcomes

Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)

Time: Week 52

Description: Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.

Measure: Sub-Study 1: Percentage of Participants with Endoscopic Response

Time: Week 52

Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.

Measure: Sub-Study 2: Number of Participants with Adverse Events

Time: Through Week 240

Secondary Outcomes

Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)

Time: Week 52

Description: Decrease of at least 100 points in CDAI from Baseline.

Measure: Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)

Time: Week 52

Description: This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

Measure: Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.

Time: Week 52

Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score. Endoscopic remission is defined per SES-CD.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission

Time: Week 52

Description: CDAI remission is defined as CDAI < 150.

Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)

Time: Through Week 52

Description: Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).

Measure: Sub-Study 1: Percentage of Participants with Endoscopic Remission

Time: Week 52

Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

Measure: Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)

Time: Baseline (Week 0) to Week 52

Description: The FACIT-F questionnaire was developed to assess fatigue.

Measure: Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

Time: Baseline (Week 0) to Week 52

Description: This is assessed by reviewing participant's hospitalization data.

Measure: Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)

Time: Week 52

Description: EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

Measure: Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline

Time: Week 52

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)

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)

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.

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


HPO Nodes