A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05528510Tipo: INTERVENTIONALInicio: 13 de sept de 2022Fin estimado: 6 de oct de 2028

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Signed informed consent form
years of age or older
Documented diagnosis of ulcerative colitis (UC) 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

Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
Receiving prohibited medications and treatments
UC limited to the rectum only
Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

Intervenciones

drug

Guselkumab Dose 1

Guselkumab (Dose 1) will be administered as SC injection.

drug

Guselkumab Dose 2

Guselkumab (Dose 2) will be administered as SC injection.

drug

Guselkumab Dose 3

Guselkumab (Dose 3) will be administered as SC injection.

other

Placebo

Placebo will be administered as SC injection.

Ubicaciones

Cer Instituto Medico

Buenos Aires, Argentina

Hospital General de Agudos José Maria Ramos Mejía

Buenos Aires, Argentina

Clinica Adventista Belgrano

Ciudad de Buenos Aires, Argentina

Sanatorio Duarte Quiroz

Córdoba, Argentina

Hospital Privado Universitario De Cordoba

Córdoba, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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