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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Autoimmune Disorder Inflammatory Bowel Disease (IBD) Ulcerative Colitis
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 2
Study Identifier
NCT06137183, GA44839, 2023-506655-19-00
Condition
Ulcerative Colitis
Official Title
A Phase II, Multicenter Induction Study With an Active Treatment Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.
Eligibility Criteria
All
≥18 Years
No
Inclusion Criteria
- Diagnosis of UC for at least 3 months
- Moderately to severely active UC, assessed by mMS
- Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC
Exclusion Criteria
- Diagnosis of Crohn's disease or indeterminate colitis
- Suspicion of ischemic, radiation, microscopic, or infectious colitis
- Prior colectomy
- Inadequate response or loss of response to previous treatment of UC with tofacitinib, upadacitinib, or other systemic janus kinase (JAK) inhibitor
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