A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Seve⦠(NCT03104413) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
United States618 participantsStarted 2017-12-18
Plain-language summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Who can participate
Age range16 Years ā 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female aged \>=18 to \<= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
* Confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
* Demonstrated intolerance or inadequate response to biologic therapy for CD.
* If female, participant must meet the contraception recommendations.
Exclusion Criteria:
* Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
* Prior exposure to p19 inhibitors (e.g., risankizumab).
* Complications of Crohn's disease.
* Having an ostomy or ileoanal pouch.
* Known active Coronavirus Disease 2019 (COVID-19) infection.
What they're measuring
1
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timeframe: Week 12
2
US Specific: Percentage of Participants With Endoscopic Response
Timeframe: Week 12
3
Global Outside of US: Percentage of Participants With Clinical Remission
Timeframe: Week 12
4
Global Outside of US: Percentage of Participants With Endoscopic Response