A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06934226Tipo: INTERVENTIONALInicio: 15 de abr de 2025Fin estimado: 20 de ago de 2027

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention
Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
Total investigator global assessment (IGA) \>=3 at screening and baseline
Candidate for phototherapy or systemic treatment for plaque psoriasis

Criterios de exclusión

Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular)
Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
Major surgical procedure within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
Transplanted organ (with exception of a corneal transplant greater than \[\>\] 12 weeks before the first administration of study intervention)

Intervenciones

drug

JNJ-77242113

JNJ-77242113 will be administered orally.

drug

Matching Placebo to JNJ-77242113

Matching placebo will be administered orally.

drug

Ustekinumab

Ustekinumab will be administered subcutaneously.

drug

Matching Placebo to Ustekinumab

Matching placebo will be administered subcutaneously.

Ubicaciones

Consultora Integral de Salud SRL

Barrio Gral Paz Cba Capital, Argentina

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, Argentina

Mindout Research

Buenos Aires, Argentina

Instituto de Neumonologia y Dermatologia

Buenos Aires, Argentina

Buenos Aires Skin

CABA, Argentina

Investigaciones Medicas IMOBA SRL

CABA, Argentina

CIPREC

CABA, Argentina

Halitus Instituto Medico S.A. - Dermatologia y Estetica

Caba, Argentina

Mautalen Salud e Investigacion

CABA, Argentina

Hospital Italiano de Buenos Aires

CABA, Argentina

Instituto De Especialidades De La Salud SRL

Rosario, Argentina

MR Medicina Reumatologica

San Fernando, Argentina

Instituto de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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