CovidResearchTrials by Shray Alag

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Placebo for Risankizumab SCWiki

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


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2097 Risankizumab SC Wiki 1.00
drug2096 Risankizumab IV Wiki 1.00
drug1842 Placebo for Risankizumab IV Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D003424 Crohn Disease NIH 0.50

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0100280 Crohn's disease HPO 0.50

There is one clinical trial.

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

Related HPO nodes (Using clinical trials)

HP:0100280: Crohn's disease
Genes 4
CTLA4 PSTPIP1 INAVA IGHM
Protein Mutations 3
G908R R702W V600E
SNP 2
rs2062305 rs2097432