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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Charité Research Organisation GmbH
RECRUITING
Berlin
Contact Information
Primary
Reference Study ID Number: GA45735 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2026-05-06
Participants
Target number of participants: 24
Treatments
Experimental: Vixarelimab
Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period.
Related Therapeutic Areas
Sponsors
Leads: Genentech, Inc.