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



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:16 - 80
Updated:4/6/2019
Start Date:December 18, 2017
End Date:August 13, 2020
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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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.


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
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