NCT03104413
Brief summary
The objective of Study M15-991 is to evaluate the efficacy and safety of an active drug versus
placebo during induction therapy in participants with moderately to severely active CD.
Interventional study
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Age:
From 16 Years to 80 Years.
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.
