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Evaluating the effectiveness of icotrokinra for treating active psoriatic arthritis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants With Active Psoriatic Arthritis

PHASE3 · Janssen Research & Development, LLC · NCT06878404

This study is testing if a new medication called icotrokinra can help people with active psoriatic arthritis feel better compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC (industry)
Locations127 sites (Jonesboro, Arkansas and 126 other locations)
Trial IDNCT06878404 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of icotrokinra in participants with active psoriatic arthritis who have not previously received biologic treatments. Participants will be randomly assigned to receive either icotrokinra or a placebo, with the primary focus on measuring the reduction in signs and symptoms of psoriatic arthritis. The study will include individuals diagnosed with psoriatic arthritis for at least three months and exhibiting specific clinical criteria. The results will help determine if icotrokinra is a viable treatment option for this patient population.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with active psoriatic arthritis for at least three months who meet specific clinical criteria.

Not a fit: Patients who have previously received biologic treatments for psoriatic arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from active psoriatic arthritis.

How similar studies have performed: Other studies have shown promise in evaluating similar biologic treatments for psoriatic arthritis, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Jonesboro, Arkansas and 126 other locations

+77 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Arthritis, Psoriatic

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.