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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called icotrokinra to see how well it works for people with active psoriatic arthritis (PsA). PsA is a type of arthritis that can cause joint pain and swelling, along with skin problems like psoriasis. The trial aims to find out if icotrokinra can help reduce the signs and symptoms of this condition compared to a placebo, which is a treatment that doesn’t contain any active medication.

To participate, individuals need to have been diagnosed with psoriatic arthritis for at least three months and must be experiencing active symptoms, such as swollen and tender joints. Participants should also have at least one psoriasis skin patch or nail changes. The study is currently looking for both men and women aged 65 and older who have not previously received biologic medications for their psoriatic arthritis. Those who join the trial can expect to be monitored closely for their symptoms and overall health while taking the study medication. It's important to note that certain health conditions or previous treatments may exclude someone from participating in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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