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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.
Z. Stella Sever Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03398148
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Inclusion Criteria:
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
Digestive Systems & Liver Disease
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Study Locations

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Location
Hershey, PA