A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Eligibility criteria

Qualifiers

Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1)

Have a diagnosis of 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) >= 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Icotrokinra
  • Placebo

Treatment groups

750 Participants
are divided into 3 treatment groups

Locations

216
Argentina
ARCIS Salud SRL Aprillus asistencia e investigacionC1406AGA, Buenos Aires Argentina
Hospital Militar Central Cir. My. Dr. Cosme ArgerichC1426, Buenos Aires Argentina
Instituto Medico De Alta Complejidad (IMAC)B1643CRO, Buenos Aires Argentina
ArsemaC1431, Ciudad de Buenos Aires Argentina

Sponsors and collaborators

Janssen Research & Development, LLC

Lead sponsor