Resumen del Estudio
Este estudio clínico de Fase 3 evalúa el potencial de Tulisokibart (MK-7240), un nuevo anticuerpo monoclonal humanizado, para tratar a pacientes que sufren de Enfermedad de Crohn activa de moderada a severa. El objetivo principal es ofrecer una alternativa terapéutica a aquellos pacientes que no han respondido adecuadamente, han perdido respuesta o no toleran los tratamientos actuales, como esteroides o terapias biológicas convencionales. El protocolo se divide en dos sub-estudios diseñados para medir tanto la inducción (respuesta rápida) como el mantenimiento de la remisión. Se analizará si el fármaco es capaz de reducir significativamente los síntomas clínicos (como el dolor abdominal y la frecuencia de las deposiciones) y, crucialmente, si logra la curación de la mucosa intestinal (respuesta endoscópica) a las 12 y 52 semanas.
Criterios de Elegibilidad
Resumen de Elegibilidad:Pueden participar pacientes con diagnóstico confirmado de Enfermedad de Crohn (mínimo 3 meses) de moderada a severa, que hayan fallado a tratamientos previos (corticoides, inmunomoduladores o biológicos). Se excluyen pacientes con colitis ulcerosa, ostomías, intestino corto, estenosis sintomáticas o infecciones activas graves.
- Has had a diagnosis of CD at least 3 months before study.
- Has moderately to severely active CD.
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.
- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Has current stoma or need for colostomy or ileostomy.
- Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.
- Has surgical bowel resection within 3 months of study.
- Has prior or current gastrointestinal dysplasia.
- Has chronic infection requiring ongoing antimicrobial treatment.
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.
- Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has active tuberculosis.
- Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.