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

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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

Key facts

Study ID

NCT03104413

Run by

AbbVie

People needed

618

Starts

2017-12-18

Expected to finish

2021-05-19

Last updated by the study team

2022-06-14

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Confirmed diagnosis of CD for at least 3 months prior to Baseline.
• Crohn's disease activity index (CDAI) score 220 - 450 at 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, participant must meet the contraception recommendations.

You may not qualify 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 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.
• Having an ostomy or ileoanal pouch.
• Known active Coronavirus Disease 2019 (COVID-19) infection.

Where it is running

• HonorHealth Research Institute - Shea /ID# 165825 — Scottsdale, Arizona, United States
• Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882 — Tempe, Arizona, United States
• University of Arizona /ID# 158305 — Tucson, Arizona, United States
• Duplicate_Atria Clinical Research /ID# 164504 — Little Rock, Arkansas, United States
• Southern California Res. Ctr. /ID# 211989 — Coronado, California, United States
• Newport Huntington Medica /ID# 213034 — Huntington Beach, California, United States
• UC San Diego Health Systems /ID# 155576 — La Jolla, California, United States
• United Medical Doctors /ID# 207887 — Los Alamitos, California, United States
• TLC Clinical Research Inc /ID# 212501 — Los Angeles, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655 — Los Angeles, California, United States
• United Medical Doctors - Murrieta /ID# 158278 — Murrieta, California, United States
• Peak Gastroenterology Associates, PC /ID# 165832 — Colorado Springs, Colorado, United States
• Rocky Mountain Pediatric Gastroenterology /ID# 207171 — Lone Tree, Colorado, United States
• Western Connecticut Medical Group /ID# 165874 — Danbury, Connecticut, United States
• Seffner Premier Health Care, PA /ID# 162259 — Brandon, Florida, United States
• Clinical Research of West Florida, Inc /ID# 205864 — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc /ID# 208127 — Clearwater, Florida, United States
• South Lake Pain Institute, Inc /ID# 162798 — Clermont, Florida, United States
• Omega Research Maitland, LLC /ID# 171080 — DeBary, Florida, United States
• Universal Axon Clinical Research /ID# 165426 — Doral, Florida, United States
• SIH Research Mumtaz, Inc /ID# 163081 — Kissimmee, Florida, United States
• Alliance Medical Research /ID# 163834 — Lighthouse PT, Florida, United States
• Cfagi Llc /Id# 202482 — Maitland, Florida, United States
• University of Miami /ID# 155011 — Miami, Florida, United States
• Phoenix VA Health Care System /ID# 162261 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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