Estudio de fase III, multicéntrico, doble ciego, controla... | EligiMed

Estudio de fase III, multicéntrico, doble ciego, controlado con placebo, con tratamiento continuo para evaluar la eficacia y la seguridad del tratamiento de inducción y mantenimiento con RO7790121 en pacientes con enfermedad de Crohn moderadamente a gravemente activa

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06819878Tipo: INTERVENTIONALInicio: 17 de mar de 2025Fin estimado: 31 de dic de 2033

Resumen

Este estudio de fase III, multicéntrico, doble ciego, controlado con placebo con tratamiento continuo evaluará la eficacia y la seguridad del tratamiento de inducción y mantenimiento con afimkibart (también conocido como RO7790121) en participantes con enfermedad de Crohn (EC) moderadamente a gravemente activa.

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Confirmed diagnosis of CD
Moderately to severely active CD
Bodyweight \>= 40 kilogram (kg)
Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
Males and females of childbearing potential must meet protocol criteria for contraception requirements

Criterios de exclusión

Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
Diagnosis of short gut or short bowel syndrome
Presence of an ileostomy, colostomy or ileoanal pouch
Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
Presence of abdominal or perianal abscess
Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
Current diagnosis or suspicion of primary sclerosing cholangitis
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening
Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Intervenciones

drug

Afimkibart

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

drug

Placebo

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Ubicaciones

Hospital Britanico

Ciudad Autonoma Bs As, Argentina

RECRUITING

Hospital Provincial del Centenario

Rosario, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

ColaboradorChugai Pharmaceutical

Contactos

Reference Study ID Number: GA45331 https://forpatients.roche.com/

CONTACT

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada)

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.