A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis

Genentech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Moderate to Severe Ulcerative Colitis

Treatments: Drug: Vixarelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06693908

2024-516287-29-00 (EU Trial (CTIS) Number)

GA45735

Details and patient eligibility

About

This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of UC established at least 3 months
• Moderately to severely active UC
• Participants must meet criteria for either advanced therapy failure or conventional therapy failure

Exclusion criteria

• Diagnosis of Crohn's disease or indeterminate colitis
• Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis
• Prior colectomy
• Prior treatment with systemic janus kinase (JAK) inhibitors

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Vixarelimab

Experimental group

Description:

Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period.

Treatment:

Drug: Vixarelimab