At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating UTTR1147A, UTTR1147A Placebo, and 2 other interventions for Ulcerative Colitis. Completed, enrolled 195 participants across 72 sites in 16 countries.
Detailed Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.
Study Details
Timeline
Interventions
UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.
The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.
Vedolizumab will be administered IV, as specified in the prescribing information.
The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.