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

NCT06878404

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Arthritis, Psoriatic

Interventions: Icotrokinra, Placebo, Active reference comparator

Countries: United States, Argentina, Australia, Bulgaria, China, Czechia, Denmark, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (155)
  • Jonesboro, Arkansas, United States
  • DeBary, Florida, United States
  • Plantation, Florida, United States
  • Tampa, Florida, United States
  • Willowbrook, Illinois, United States
  • Charlotte, North Carolina, United States
  • Duncansville, Pennsylvania, United States
  • Allen, Texas, United States
  • Harlingen, Texas, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Ciudad de San Miguel de Tucuman, Argentina
  • Córdoba, Argentina
  • San Fernando, Argentina
  • San Isidro, Argentina
  • Ipswich, Australia
  • Maroochydore, Australia
  • Parramatta, Australia
  • South Woodville, Australia
  • Tiwi, Australia
  • Haskovo, Bulgaria
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • Beijing, China
  • Beijing, China
  • Changchun, China
  • Changsha, China
  • + 125 more on CT.gov