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Recruiting Phase 1, Phase 2 NCT06693908
A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis
Trial Parameters
Condition Moderate to Severe Ulcerative Colitis
Sponsor Genentech, Inc.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 24
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-31
Completion 2026-05-03
Interventions
Vixarelimab
Brief Summary
This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).
Eligibility Criteria
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