A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
Phase 3 – large-scale trial before approval
Conditions:
Arthritis, Psoriatic
Sponsor: Janssen Research & Development, LLC
trial.available_in:
БГ
Overview
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.
Who can participate
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
15
Argentina (1)
Cosultorios Reumatologógicos Pampa
Buenos Aires
Australia (1)
Ipswich Hospital
Ipswich
Bulgaria (1)
MC Medtech Services Ltd
Haskovo
China (1)
Peking University Third Hospital
Beijing
Czech Republic (1)
Revmatologie s r o
Brno
Denmark (1)
Aarhus University Hospital
Aarhus N
Hong Kong (1)
Prince of Wales Hospital
Hong Kong
Hungary (1)
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz