RecruitingPhase 1Phase 2NCT06693908

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

A Phase Ic Open-label Study to Evaluate the Pharmacodynamic Effects, Pharmacokinetics, and Safety of Vixarelimab in Patients With Moderate to Severe Active Ulcerative Colitis


Sponsor

Genentech, Inc.

Enrollment

24 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new biologic drug called vixarelimab in people with moderate to severe active ulcerative colitis (UC) — a chronic inflammatory bowel disease causing colon inflammation. Vixarelimab works by blocking specific proteins involved in the inflammatory process. **You may be eligible if...** - You have been diagnosed with UC for at least 3 months - Your UC is currently moderately to severely active - You have tried and failed standard treatments (such as steroids, immunosuppressants) or more advanced therapies (biologics or small molecule drugs) **You may NOT be eligible if...** - You have Crohn's disease or a type of colitis that is uncertain - There is suspicion of ischemic colitis, radiation colitis, microscopic colitis, or infectious colitis - You have had your colon surgically removed - You have previously been treated with JAK inhibitors (a class of drugs that suppress the immune system) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVixarelimab

Vixarelimab will be administered as per the schedule specified.


Locations(1)

Charité Research Organisation GmbH

Berlin, Germany

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NCT06693908