Summary

for people ages 16-80 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Crohn's Disease ABBV-066 BI 655066 Crohn Disease risankizumab SC risankizumab IV

Eligibility

You can join if…

Open to people ages 16-80

  • 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

You CAN'T join if...

  • 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 (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
  • Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or p19 inhibitors(e.g., risankizumab)
  • Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
  • Having an ostomy or ileoanal pouch

Locations

  • UC San Diego Health Systems not yet accepting patients
    San Diego California 92037 United States
  • United Gastroenterologists not yet accepting patients
    Murrieta California 92563 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03104413
Phase
Phase 3
Study Type
Interventional
Last Updated
June 13, 2018