A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis
- Registration Number
- NCT06693908
- Lead Sponsor
- Genentech, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vixarelimab Vixarelimab Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period.
- Primary Outcome Measures
Name Time Method Change From Baseline in Fibroblast Products From Colonic Tissue Baseline up to approximately 3 months
- Secondary Outcome Measures
Name Time Method Serum Concentration of Vixarelimab Up to approximately 3 months Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab Up to approximately 3 months Number of Participants With Adverse Events (AEs), With Severity Determined According to Division of AIDS (DAIDS) Toxicity Grading Scale Up to approximately 3 months
Trial Locations
- Locations (1)
Charité Research Organisation GmbH
🇩🇪Berlin, Germany