NCT06137183

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) 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.

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Vixarelimab	Vixarelimab will be administered as per the schedule specified in the respective arms.
DRUG	Placebo	Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-06-16
• Completion: 2025-06-16
• First posted: 2023-11-18
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

65 sites across 12 countries: United States, Brazil, China, Czechia, France, Greece, Italy, Mexico, Poland, Serbia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study