Last updated 9 days ago
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
980 patients around the world
Available in Puerto Rico, United States, Brazil, Argentina, Mexico, Chile
Sanofi
7Research sites
980Patients around the world
This study is for people with
Ulcerative colitis
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development.Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline.Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies.
- Participants with Crohn's Disease (CD), indeterminate colitis.Current diagnosis of Ulcerative Proctitis.Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections.Prior or current high-grade gastrointestinal (GI) dysplasia.Participants on treatment with but not on stable doses of conventional therapies prior to baseline.Participants with prohibited medications or therapies prior to baseline.Participants with previous exposure to anti-TL1A investigational therapy.
Sites
Sanatorio de la Mujer - Rosario
Recruiting
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
I.M.E.P. Instituto Médico Elsa Pérez
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Hospital Privado de Córdoba
Recruiting
Hospital Italiano de La Plata
Recruiting
Gastroenterología Diagnóstica y Terapéutica - CABA
Recruiting
StudySUNSCAPE-1
SponsorSanofi
Study typeInterventional
Conditions
Ulcerative colitis
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07184996
