TerminatedPhase 2

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

Stopped: Based on a futility analysis, which suggested that the Moonglow study was unlikely to meet its primary endpoint.

United States79 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants With Clinical Remission at Week 12

Timeframe: At Week 12

Trial details

NCT IDNCT06137183

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-16

Results submitted2025-12-24

View on ClinicalTrials.gov More Ulcerative Colitis trials