Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de JNJ-77242113 para el tratamiento de participantes con psoriasis en placas de moderada a grave con retiro aleatorizado y retratamiento

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06095115Tipo: INTERVENTIONALInicio: 12 de oct de 2023Fin estimado: 6 de abr de 2027

Resumen

El propósito de este estudio es evaluar la eficacia de JNJ-77242113 en participantes con psoriasis en placas de moderada a grave.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Diagnosis of plaque psoriasis, with or without psoriatic arthritis, 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
Candidate for phototherapy or systemic treatment for plaque psoriasis
A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

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 or its excipients
Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a 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

Placebo

Placebo will be administered orally

Ubicaciones

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Argentina

Derma Internacional S A

Buenos Aires, Argentina

Psoriahue

CABA, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

Instituto De Especialidades De La Salud SRL

Rosario, Argentina

MR Medicina Reumatologica

San Fernando, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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