Estudio de fase 3, multicéntrico, aleatorizado, doble cie... | EligiMed

Estudio de fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de JNJ-77242113 para el tratamiento de participantes sin tratamiento biológico previo con artritis psoriásica activa

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06878404Tipo: INTERVENTIONALInicio: 21 de feb de 2025Fin estimado: 21 de nov de 2028

Resumen

El objetivo de este estudio es evaluar la eficacia de icotrokinra en comparación con placebo en participantes con artritis psoriásica (APs) activa, mediante la evaluación de la reducción en los signos y síntomas de la APs.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have active plaque psoriasis with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with psoriasis
A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Criterios de exclusión

Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease
Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

Intervenciones

drug

Icotrokinra

Icotrokinra will be administered.

drug

Placebo

Placebo will be administered.

drug

Active reference comparator

Active reference drug will be administered.

Ubicaciones

Cosultorios Reumatologógicos Pampa

Buenos Aires, Argentina

Mindout Research

Buenos Aires, Argentina

Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

Buenos Aires, Argentina

Arsema

Ciudad de Buenos Aires, Argentina

Centro Medico Privado de Reumatologia Tucuman

Ciudad de San Miguel de Tucuman, Argentina

Consultora Integral de Salud SRL

Córdoba, Argentina

MR Medicina Reumatologica

San Fernando, Argentina

Instituto Medico De Alta Complejidad (IMAC)

San Isidro, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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