A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

  • Interventional
  • Recruiting
  • NCT03104413
Eligibility Details Visit Clinicaltrials.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

Gender
All

Age Group
16 Years to 80 Years

Accepting Healthy Volunteers?
No

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, subjects 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 biologic therapy for CD

         - If female, subject must meet the contraception recommendations

        Exclusion Criteria:

         - Subject with a current diagnosis of ulcerative colitis or indeterminate colitis

         - Subjects 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 (strictures, stenosis, short bowel, etc)

         - Having an ostomy or ileoanal pouch

At a Glance

National Government IDNCT03104413

IRB#IRB18-0737

Lead SponsorAbbVie

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
16 Years to 80 Years
Recruiting