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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06589986Tipo: INTERVENTIONALInicio: 17 de sept de 2024Fin estimado: 30 de ene de 2031

Resumen

Este estudio de fase III, multicéntrico, doble ciego, controlado con placebo y de tratamiento continuo evaluará la eficacia y seguridad de afimkibart (RO7790121) en comparación con placebo en participantes con colitis ulcerosa (CU) de moderada 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

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

CIPREC Centro de Investigacion y Prevencion Cardiovascular

Ciudad Autonoma Buenos Aires, Argentina

Expertia S.A- Mautalen Salud e Investigación

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

ColaboradorChugai Pharmaceutical

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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