Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
16–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
