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

  • End date
    Apr 20, 2023
  • participants needed
  • sponsor
Updated on 1 August 2021
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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.

Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment placebo for risankizumab, risankizumab IV, risankizumab SC, placebo for rizankizumab, rizankizumab SC
Clinical Study IdentifierNCT03398148
Last Modified on1 August 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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