Estudio de fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de JNJ-77242113 en el tratamiento de participantes con psoriasis en placas que afecta áreas especiales

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06095102Tipo: INTERVENTIONALInicio: 12 de oct de 2023Fin estimado: 17 de feb de 2027

Resumen

El propósito del estudio es evaluar la eficacia de JNJ-77242113 en participantes con psoriasis en placas que afecta áreas especiales (cuero cabelludo, genitales y/o palmas de las manos y plantas de los pies).

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
Candidate for phototherapy or systemic treatment for plaque psoriasis
Need to meet criteria: Total body surface area (BSA) greater than or equal to (\>=)1 percent (%) at screening and baseline, and investigator global assessment (IGA) (overall) \>=2 at screening and baseline and at least one of the following: scalp-specific investigator global assessment (ss-IGA) score \>=3 at screening and baseline, and/or static physician's global assessment of genitalia (sPGA-G) \>=3 at screening and baseline, and/or physician's global assessment of hands and feet (hf-PGA) score \>=3 at screening and baseline
Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis
Confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline

Criterios de exclusión

Nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
Dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-PGA \>=3 at baseline)
Current drug-induced psoriasis (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

Intervenciones

drug

JNJ-77242113

JNJ-77242113 will be administered orally.

drug

Placebo

Placebo will be administered orally.

Ubicaciones

CIPREC

Buenos Aires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Argentina

Conexa Investigacion Clinica S.A.

CABA, Argentina

CEDIC Centro de Investigacion clinica

Caba, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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