Estudio de fase III, multicéntrico, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de la terapia de inducción con RO7790121 en pacientes con colitis ulcerosa moderadamente a gravemente activa

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06588855Tipo: INTERVENTIONALInicio: 11 de dic de 2024Fin estimado: 30 de dic de 2029

Resumen

Este estudio de fase III, multicéntrico, doble ciego, controlado con placebo evaluará la eficacia y seguridad de la terapia de inducción con afimkibart (RO7790121) comparada con placebo en participantes con colitis ulcerosa (CU) moderadamente a gravemente activa.

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Confirmed diagnosis of UC
Moderately to severely active UC assessed by mMS
Bodyweight \>= 40 kilogram (kg)
Up to date with colorectal cancer (CRC) screening performed according to local standards
Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
Males and females of childbearing potential must meet protocol criteria for contraception requirements

Criterios de exclusión

Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
Presence of an ostomy or ileoanal pouch
Current diagnosis or suspicion of primary sclerosing cholangitis
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell 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)
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

Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.

drug

Placebo

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Ubicaciones

Hospital Britanico

Ciudad Autonoma Bs As, Argentina

RECRUITING

Instituto Medico CER

Quilmes, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

Contactos

Reference Study ID Number: GA45330 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.

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