A Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of JNJ-77242113 for the treatment of biologic-experienced and biologic-naive participants with active psoriatic arthritis
Arthritis, Psoriatic
This study is a 52-week main study with a 52-week blinded long-term extension (LTE). At Week 0, participants will be randomly (by chance) assigned to one of the 3 treatment arms: Group I: icotrokinra Dose 1, Group II: icotrokinra Dose 2, Group III: Placebo. At Week 16, participants will cross over to receive Dose 1 or Dose 2 icotrokinra once daily. The randomisation process uses an online tool. The main study will consist of: • Screening Period (Up to 5 weeks) • Placebo-controlled period (Up to 16 weeks) • Blinded active-treatment period (up to 36 weeks) • Safety follow-up visit (4 weeks after the last dose of study treatment) All participants who complete the main study will have the option to participate in the 52-week blinded LTE period (48 weeks of active treatment plus 4 weeks of safety follow-up).
Current inclusion criteria as of 20/05/2026: 1. Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (>=) one of the following: 1.1. Non-biologic disease modifying antirheumatic drug (DMARD) therapy 1.2. Apremilast therapy 1.3. Biologic-agent (limited to only one) 2. 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. 3. Have active PsA as defined by: 3.1. At least three swollen joints and at least three tender joints at screening and at baseline. 3.2. C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory. 4. Have at least one 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. 5. Have active plaque psoriasis with at least one psoriatic plaque of >=2 cm diameter or nail changes consistent with psoriasis. 6. 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. Previous inclusion criteria: 1. Participants must have been previously treated with one biologic agent for psoriatic arthritis (PsA) or psoriasis and the reason for discontinuation must be documented. 2. 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. 3. Have active PsA as defined by: 3.1. At least three swollen joints and at least three tender joints at screening and at baseline. 3.2. C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per dec
1. 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. 2. Currently has a malignancy or has a history of malignancy within 5 years prior to screening. 3. Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients. 4. 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. 5. Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator’s opinion, would have the potential to interfere with efficacy assessments.