Estudio de Fase 3, Multicéntrico, Aleatorizado, Doble Cie... | EligiMed

Estudio de Fase 3, Multicéntrico, Aleatorizado, Doble Ciego, Controlado con Placebo para Evaluar la Eficacia y Seguridad de JNJ-77242113 en el Tratamiento de Participantes con Experiencia en Biológicos con Artritis Psoriásica Activa

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06807424Tipo: INTERVENTIONALInicio: 9 de ene de 2025Fin estimado: 18 de oct de 2028

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and have discontinued treatment for any reason. The reason for discontinuation must be documented
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 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
Currently has a malignancy or has a history of malignancy within 5 years prior to screening
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.

Ubicaciones

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, Argentina

RECRUITING

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, Argentina

RECRUITING

Hospital Militar Central Cir. My. Dr. Cosme Argerich

Buenos Aires, Argentina

RECRUITING

Arsema

Ciudad de Buenos Aires, Argentina

RECRUITING

Centro Medico Privado de Reumatologia Tucuman

Ciudad de San Miguel de Tucuman, Argentina

RECRUITING

MR Medicina Reumatologica

San Fernando, Argentina

RECRUITING

Patrocinadores

PrincipalJanssen Research & Development, LLC

Contactos

Study Contact

CONTACT

Participate-In-This-Study1@its.jnj.com 844-434-4210

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.