A Study of Icotrokinra for Psoriatic Arthritis

This study is testing a new medication called icotrokinra (JNJ-77242113) to see how well it works and if it's safe for people with active psoriatic arthritis (PsA). Researchers want to compare icotrokinra to a placebo (an inactive substance) to see if it can reduce the signs and symptoms of PsA. You might be able to join if you are 18 or older, have active PsA, and have tried at least one other treatment like a non-biologic DMARD, apremilast, or one biologic agent. The main goal is to see what percentage of participants show a 20% improvement in their PsA symptoms after 16 weeks. The study plans to enroll about 750 people, but its current status is unclear.

Study design
This is an interventional study comparing icotrokinra to a placebo. It plans to enroll about 750 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 16, indicating follow-up for at least this duration.

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NCT06807424

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~750 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:IcotrokinraPlacebo

At a glance

Recruiting sites
215 of 236 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Measured over Week 16
Arthritis, Psoriatic
236 sites across 39 states
China25
Poland19
Japan16
Hungary15
Italy11
Spain11
United Kingdom11
Czechia10
  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16Week 16

    The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).