Summary

Eligibility
for people ages 16-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Crohn's Disease Crohn's Disease (CD) Risankizumab ABBV-066 BI 655066 Crohn Disease Antibodies, Monoclonal risankizumab IV risankizumab SC

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, participants 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, participant must meet the contraception recommendations

You CAN'T join 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 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
  • Known active Coronavirus Disease 2019 (COVID-19) infection

Locations

  • University of California, San Francisco - 16th St /ID# 157143
    San Francisco California 94158 United States
  • Cedars-Sinai Medical Center - West Hollywood /ID# 163842
    West Hollywood California 90048 United States
  • TLC Clinical Research Inc /ID# 212503
    Beverly Hills California 90211-2091 United States
  • Gastrointestinal Biosciences /ID# 162656
    Los Angeles California 90067-2001 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related info
ID
NCT03105128
Phase
Phase 3
Study Type
Interventional
Last Updated