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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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
• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• AARA Clinical Research, Glendale, Arizona, United States
• AARA Clinical Research 1, Mesa, Arizona, United States
• Arthritis and Rheumatism Associates ARA Jonesboro, Jonesboro, Arkansas, United States
• Clinical Research of West Florida, Clearwater, Florida, United States
• Omega Research Consultants, DeBary, Florida, United States
• Suncoast Clinical Research, New Port Richey, Florida, United States
• Integral Rheumatology And Immunology Specialists, Plantation, Florida, United States
• Clinical Research of West Florida 1, Tampa, Florida, United States
• Clinic of Robert Hozman, Skokie, Illinois, United States
• Klein And Associates M D P A, Hagerstown, Maryland, United States
• DM Clinical Research 1, Brookline, Massachusetts, United States
• St Paul Rheumatology PA, Eagan, Minnesota, United States

+ 212 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06807424.