A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis

CompletadoFase 2ClinicalTrials.gov

ID: NCT06049017Tipo: INTERVENTIONALInicio: 9 de oct de 2023Fin estimado: 5 de ene de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Signed informed consent form 18 years of age or older
Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
Moderately to severely active UC as per the modified Mayo score
Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Criterios de exclusión

Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
UC limited to rectum only or to less than (\<) 15 centimeters (cm) of colon
Presence of a stoma
Presence or history of fistula
History of extensive colonic resection (example, \<30 cm of colon remaining)
Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease

Intervenciones

drug

JNJ-77242113

JNJ-77242113 tablet will be administered orally.

drug

Placebo

Placebo tablet will be administered orally.

Ubicaciones

Cer Instituto Medico

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Gedyt - Consultorios Gastroenterologia

Buenos Aires, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Sanatorio 9 de Julio

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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