NCT03105128
Brief summary
The purpose of this study is to evaluate the efficacy and safety of an active drug versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (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.
- Diagnosis of CD for at least 3 months prior to 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 conventional or 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 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.
