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Active (not recruiting) Phase 3 NCT06878404

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
Budapest
India (1)
Marengo Cims Hospital
Ahmedabad
Japan (1)
Fukuoka University Hospital
Fukuoka
Poland (1)
Osteo Medic S C Artur Racewicz Jerzy Supronik
Bialystok
Spain (1)
Hosp Univ A Coruna
A Coruña
Taiwan (1)
Chang Gung Memorial Hospital
Kaohsiung City
Thailand (1)
Phramongkutklao Hospital
Bangkok
United States (1)
Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro , Arkansas
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.02.2025
Completion date
04.02.2028
Registry ID
NCT06878404
Source
anzctr
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