Last updated 3 days ago
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
540 patients around the world
Available in Argentina, United States
Janssen Research & Development, LLC
5Research sites
540Patients around the world
This study is for people with
Arthritis
Psoriasic arthritis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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: At least 3 swollen joints and at least 3 tender joints at screening and at baseline.Have active PsA as defined by: 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.
- 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.
Sites
Consultorios Reumatológicos Pampa
Recruiting
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Recruiting
Centro Médico Privado de Reumatología - San Miguel de Tucumán
Recruiting
Centro Privado de Medicina Familiar Mindout Research
Recruiting
Centro Médico Arsema
Recruiting
StudyICONIC-PsA 1
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Psoriasic arthritis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06878404
