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

Ulcerative Colitis Clinical Trial

Official title:
A Phase II, Multicenter Induction Study With an Active Treatment Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.

Clinical Trial Description

This study consists of two periods: 1. An induction period which will test the induction of clinical remission; 2. An optional active treatment extension (ATE) period which will explore durability of clinical response and remission in which all participants will receive vixarelimab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06137183
Study type Interventional
Source Genentech, Inc.
Contact Reference Study ID Number: GA44839 https://forpatients.roche.com
Phone 888-662-6728 (U.S. Only)
Email global-roche-genentech-trials@gene.com
Status Recruiting
Phase Phase 2
Start date May 1, 2024
Completion date May 1, 2027
View Details
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