Overview

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Status:
Recruiting
Trial end date:
2027-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Criteria
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

- Prior treatment with systemic janus kinase (JAK) inhibitors