Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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Study Matches
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis
The objective of Sub-Study 1 (Phase 2b induction) is to characterize 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 (Phase 3 induction). The objective of Sub-Study 2 (Phase 3 induction) is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Confirmed diagnosis of UC for at least 3 months prior to Baseline Males or females ≥ 18 and ≤ 80 years of age Demonstrated intolerance or inadequate response to one or more categories of drugs Females of childbearing potential must have a Subject must be able and willing to give written informed consent and to comply
Exclusion Criteria:
Subject with a current diagnosis of Crohn's disease (CD) or IBD-unclassified Subject on oral UC-related antibiotics, oral aminosalicylates, oral corticosteroids or on immunomodulators Subject who received any live bacterial or viral vaccination within 35 days Subject who received fecal microbial transplantation within 35 days Subject who received any approved biologic agent or ustekinumab [Stelara