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

Last updated: May 22, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Treatment

Placebo

Icotrokinra

Active reference comparator

Clinical Study ID

NCT06878404
77242113PSA3001
77242113PSA3001
2023-509239-19-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the firstadministration of study intervention and meet classification criteria for psoriaticarthritis (CASPAR) at screening

  • Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tenderjoints at screening and at baseline (b) C-reactive protein (CRP) greater than orequal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the centrallaboratory

  • 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 diameteror nail changes consistent with psoriasis

  • A female participant of childbearing potential must have a negative highly sensitiveserum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test atWeek 0 prior to administration of study intervention

Exclusion

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 uncontrolledrenal, 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 itsexcipients

  • Has other inflammatory diseases that might confound the evaluations of benefit oficotrokinra therapy, including but not limited to rheumatoid arthritis (RA),systemic lupus erythematosus, or lyme disease

  • Participants with fibromyalgia or osteoarthritis symptoms that, in theinvestigator's opinion, would have potential to interfere with efficacy assessments

Study Design

Total Participants: 540
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 21, 2025
Estimated Completion Date:
December 29, 2028

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  • Linkou Chang Gung Memorial Hospital

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