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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called icotrokinra to see how well it works and how safe it is for people with active psoriatic arthritis (PsA) who have already tried other biologic treatments. The goal is to find out if icotrokinra can help reduce the signs and symptoms of PsA, such as swollen and tender joints.

To participate in this study, you need to have been diagnosed with psoriatic arthritis for at least three months and have previously received at least one biologic treatment for it or for psoriasis. You should also have signs of active PsA, like swollen joints and signs of skin psoriasis. During the trial, participants will receive either the medication or a placebo (a dummy treatment) to compare the effects. It’s important to note that there are some health conditions that might prevent someone from participating, so discussing your medical history with the study team will be essential. If you're interested, this trial is currently recruiting participants of all genders between the ages of 65 and 74.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and 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
• Exclusion Criteria:
• • 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