A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:16 - 80
Updated:3/23/2019
Start Date:May 10, 2017
End Date:March 14, 2021
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 of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus
placebo during induction therapy in subjects with moderately to severely active Crohn's
disease (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 conventional or 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 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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