Last updated 6 days ago
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
210 patients around the world
Available in Brazil, Mexico
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
clinical response and remission in which all participants will receive vixarelimab.
Genentech, Inc.
12Research sites
210Patients around the world
This study is for people with
Ulcerative colitis
Moderate/severe ulcerative colitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Hospital Universitário Clementino Fraga Filho
Recruiting
CliaGEN - Gastroenterologia e Nutrição em Salvador
Recruiting
L2IP Instituto de Pesquisas Clínicas
Recruiting
Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
Recruiting
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Associação Hospitalar Moinhos de Vento
Recruiting
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
Recruiting
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Recruiting
Pesquisare Saude
Recruiting
Praxis Pesquisa Médica s/s LTDA
Recruiting
SponsorGenentech, Inc.
Conditions
Moderate/severe ulcerative colitis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06137183
