Last updated 10 days ago
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
980 patients around the world
Available in Argentina, Colombia, Mexico, Chile, Puerto Rico, United States
Sanofi
16Research sites
980Patients around the world
This study is for people with
Crohn's disease
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 Crohn's Disease (CD) for at least 3 months prior to baseline.Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs).
- Participants with Ulcerative Colitis (UC) or indeterminate colitis.Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum.Prior or current high-grade gastrointestinal (GI) dysplasia.Participants on treatment with but not on stable doses of conventional therapy prior to baseline.Participants receiving prohibited medications or therapies.Participants with previous exposure to anti-TL1A investigational therapy.
Sites
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Sanatorio de la Mujer - Rosario
Recruiting
I.M.E.P. Instituto Médico Elsa Pérez
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Gastroenterología Diagnóstica y Terapéutica - CABA
Recruiting
Hospital Italiano de La Plata
Recruiting
Hospital Privado de Córdoba
Recruiting
Centro de Estudios Clínicos e Investigaciones Médicas CeCim
Recruiting
Clínica Universidad de los Andes
Recruiting
Espacio EME
Recruiting
StudySTARSCAPE-1
SponsorSanofi
Study typeInterventional
Conditions
Crohn's disease
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07184931
