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
Inclusion Criteria3
- 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 Criteria4
- 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
Interventions
DRUGVixarelimab
Vixarelimab will be administered as per the schedule specified.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06693908