Status:
TERMINATED
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Lead Sponsor:
Genentech, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 inadequat...
Detailed Description
This study consists of two periods: 1. An induction period which will test the induction of clinical remission; 2. An optional active treatment extension (ATE) period which will explore durability of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT06137183
Start Date
May 1 2024
End Date
June 16 2025
Last Update
June 25 2025
Active Locations (122)
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1
Gulf Coast Gatroenterology
Fairhope, Alabama, United States, 36532
2
OM Research LLC - Camarillo - ClinEdge - PPDS
Camarillo, California, United States, 93012
3
UCLA Clinical and Translational Research Center
Los Angeles, California, United States, 90095
4
Facey Medical Foundation - Mission Hills
Mission Hills, California, United States, 91345 1116