A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib 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: NCT06143878Tipo: INTERVENTIONALInicio: 1 de feb de 2024Fin estimado: 1 de jun de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Candidate for phototherapy or systemic treatment for plaque psoriasis
Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks 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

Criterios de exclusión

Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib, or to any of the excipients or components of the study intervention
Major surgical procedure, (for example, requiring general anesthesia) 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

Intervenciones

drug

JNJ-77242113

JNJ-77242113 will be administered orally.

drug

JNJ-77242113 Matching Placebo

JNJ-77242113 matching placebo will be administered orally.

drug

Deucravacitinib

Deucravacitinib will be administered orally.

drug

Deucravacitinib Matching Placebo

Deucravacitinib matching placebo will be administered orally.

Ubicaciones

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, Argentina

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, Argentina

Halitus Instituto Medico S.A. - Dermatologia y Estetica

Caba, Argentina

Hospital Italiano de Buenos Aires

Caba, Argentina

Instituto de Neumonologia y Dermatologia

CABA, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Instituto Caici Srl.

Rosario, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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