A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2023-04-20
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Male or female aged >=18 to <= 80 years 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.

• Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.

• Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.

• Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.

• Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria:

• Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.

• Participant receiving prohibited medications and treatment.

• Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.

• Participant with currently known complications of UC (e.g., megacolon).

• No known active Coronavirus Disease - 2019 (COVID-19) infection.