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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

30Research 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

I'm a patient

I'm a referring doctor

I.M.E.P. Instituto Médico Elsa Pérez

Recruiting

Av Republica 1095, Ciudadela, Buenos Aires

Hospital Británico de Buenos Aires - CABA

Recruiting

Perdriel 74, CABA, Buenos Aires

Sanatorio de la Mujer - Rosario

Recruiting

San Luis 2493, Rosario, Santa Fe

Hospital Provincial del Centenario - Rosario, Santa Fe

Recruiting

Urquiza 3101, Rosario, Santa Fe

Hospital Italiano de La Plata

Recruiting

Av. 51 entre 29 y 30 Nro 1725, La Plata, Buenos Aires

Gastroenterología Diagnóstica y Terapéutica - CABA

Recruiting

Av. Sta. Fe 2755 piso 6 b, C1425BPB Cdad. Autónoma de Buenos Aires, Argentina

Hospital Privado de Córdoba

Recruiting

Naciones Unidas 346, Córdoba

Hospital de Câncer de Barretos - Fundação PIO XII (Hospital de AMOR)

Recruiting

Rua Antenor Duarte Villela 1331 - Barretos, Sao Paulo, 14784-400

NewData FBHC

Recruiting

Av. Des. Maynard, 174 - Cirurgia, Aracaju - SE, 49055-210, Brazil

Universidad Federal de Piauí

Recruiting

Campus Universitário Ministro Petrônio Portella - Ininga, Teresina - PI, 64049-550, Brazil

Choose your role

I'm a patient

I'm a referring doctor

StudySTARSCAPE-1

SponsorSanofi

Study typeInterventional

Conditions

Crohn's disease

Requirements

To 80 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07184931