NCT03558152

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	UTTR1147A	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.
DRUG	UTTR1147A Placebo	The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.
DRUG	Vedolizumab	Vedolizumab will be administered IV, as specified in the prescribing information.
DRUG	Vedolizumab Placebo	The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Timeline

• Start date: 2018-10-26
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2018-06-15
• Last updated: 2023-04-14
• Results posted: 2023-04-14

Locations

72 sites across 16 countries: United States, Bulgaria, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Moldova, Poland, Russia, Serbia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study