Home › Trials › NCT06807424

Evaluating Icotrokinra for Active Psoriatic Arthritis in Patients with Previous Biologic Treatment

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

Phase 3 Interventional Janssen Research & Development, LLC · NCT06807424

This study is testing a new treatment called icotrokinra to see if it can help people with active psoriatic arthritis who have already tried other biologic treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations214 sites (Glendale, Arizona and 213 other locations)
Trial IDNCT06807424 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of icotrokinra, a new treatment, compared to a placebo in participants who have previously been treated with biologic agents for active psoriatic arthritis (PsA). The study aims to assess the reduction in signs and symptoms of PsA in these patients. Participants must have a documented history of biologic treatment and meet specific criteria related to their condition. The trial is designed to provide insights into the effectiveness of icotrokinra in managing PsA symptoms.

Who should consider this trial

Good fit: Ideal candidates are individuals with a documented history of biologic treatment for psoriatic arthritis and currently experiencing active symptoms.

Not a fit: Patients who have not previously been treated with biologic agents for psoriatic arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with active psoriatic arthritis who have not responded adequately to previous biologic therapies.

How similar studies have performed: Other studies have shown promise in evaluating new treatments for psoriatic arthritis, but the specific approach of icotrokinra is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 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

Where this trial is running

Glendale, Arizona and 213 other locations

+164 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 → Find more trials like this →
Conditions Arthritis, Psoriatic
Last reviewed 2026-06-13 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.