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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT06137183

Run by

Genentech, Inc.

People needed

79

Starts

2024-05-01

Expected to finish

2025-06-16

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Clinical and Translational Research Center — Los Angeles, California, United States
• Facey Medical Foundation - Mission Hills — Mission Hills, California, United States
• Clinical Applications Laboratories, Inc. — San Diego, California, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Advanced Research Institute, Inc. — New Port Richey, Florida, United States
• Orlando Gastroenterology, P.A. — Orlando, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Henry Ford Health System — Novi, Michigan, United States
• Mayo Clinic - PPDS — Rochester, Minnesota, United States
• Delta Gastroenterology & Endoscopy Center — Southaven, Mississippi, United States
• Carolina Digestive Diseases — Greenville, North Carolina, United States
• Gastro Intestinal Research Institute of Northern Ohio — Westlake, Ohio, United States
• Tyler Research Institute, LLC — Tyler, Texas, United States
• University of Utah - Health Sciences Center - PPDS — Salt Lake City, Utah, United States
• Cliagen Clinica de Atençao em Gastroenterologia, Especialidades e Nutriçao — Salvador, Estado de Bahia, Brazil
• L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME — Brasília, Federal District, Brazil
• Hospital de Clinicas de Porto Alegre HCPA PPDS — Porto Alegre, Pará, Brazil
• Centro de Estudos Clinicos do Interior Paulista — Jaú, São Paulo, Brazil
• Pesquisare Saude — Santo André, São Paulo, Brazil
• Kaiser Hospital Dia — São José do Rio Preto, São Paulo, Brazil
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, China
• Jinhua municipal central hospital — Jinhua, China
• The First Affiliated Hospital of Nanchang University — Nanchang, China
• OM Research LLC - Camarillo - ClinEdge - PPDS — Camarillo, California, United States

Full record on ClinicalTrials.gov

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