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A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis
Autoimmune Disorder Inflammatory Bowel Disease (IBD) Ulcerative Colitis
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1/Phase 2
Study Identifier
NCT06693908, GA45735, 2024-516287-29-00
Condition
Moderate to Severe Ulcerative Colitis
Official Title
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
Study 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
All
≥18 Years
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com