A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC)

In brief

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.

Key facts

Study ID

NCT03398135

Run by

AbbVie

People needed

1242

Starts

2018-08-28

Expected to finish

2029-02-01

Last updated by the study team

2026-01-20

Who can join

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

You may qualify if…

• Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

You may not qualify if…

• Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
• Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

Where it is running

• Hoag Memorial Hosp Presbyterian /ID# 218347 — Irvine, California, United States
• UC San Diego Health System /ID# 160430 — La Jolla, California, United States
• United Medical Doctors /ID# 158574 — Los Alamitos, California, United States
• Cedars-Sinai Medical Center /ID# 163848 — Los Angeles, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934 — Los Angeles, California, United States
• UCSF Medical Center - Mount Zion /ID# 201209 — San Francisco, California, United States
• Peak Gastroenterology Associates, PC /ID# 165838 — Colorado Springs, Colorado, United States
• Rocky Mountain Pediatric Gastroenterology /ID# 207173 — Lone Tree, Colorado, United States
• Duplicate_Medical Research Center of CT /ID# 160287 — Hamden, Connecticut, United States
• Yale Univ Digestive Diseases /ID# 213265 — New Haven, Connecticut, United States
• South Lake Pain Institute, Inc /ID# 162859 — Clermont, Florida, United States
• Ctr for Advanced Gastroenterol /ID# 202820 — Maitland, Florida, United States
• University of Miami /ID# 160456 — Miami, Florida, United States
• Coral Research Clinic /ID# 158608 — Miami, Florida, United States
• South Florida Research Ph I-IV, Inc. /ID# 161844 — Miami, Florida, United States
• Gastroenterology Group Naples /ID# 165210 — Naples, Florida, United States
• Advanced Research Institute, Inc /ID# 161945 — New Port Richey, Florida, United States
• Advent Health /ID# 160393 — Orlando, Florida, United States
• Endoscopic Research, Inc. /ID# 206709 — Orlando, Florida, United States
• Omega Research Group /ID# 203105 — Orlando, Florida, United States
• Duplicate_Lenus Research & Medical Group /ID# 169727 — Sweetwater, Florida, United States
• Clinical Research Trials of Florida, Inc. /ID# 201794 — Tampa, Florida, United States
• Duplicate_AdventHealth Tampa /ID# 170482 — Tampa, Florida, United States
• Gastroenterology Associates of Central Georgia, LLC /ID# 160513 — Macon, Georgia, United States
• Southern California Res. Ctr. /ID# 169659 — Coronado, California, United States

Full record on ClinicalTrials.gov

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