A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Arthritis, Psoriatic
In brief
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.
Key facts
- Study ID
- NCT06878404
- Run by
- Janssen Research & Development, LLC
- People needed
- 552
- Starts
- 2025-02-21
- Expected to finish
- 2028-02-04
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Omega Research Consultants — DeBary, Florida, United States
- Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States
- Clinical Research of West Florida — Tampa, Florida, United States
- Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States
- Joint and Muscle Research Institute — Charlotte, North Carolina, United States
- Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
- Arthritis and Rheumatology Research Institute — Allen, Texas, United States
- Naiara Alvarez MD Integrative Rheumatology of South TX — Harlingen, Texas, United States
- Cosultorios Reumatologógicos Pampa — Buenos Aires, Argentina
- Mindout Research — Buenos Aires, Argentina
- Hospital Central Militar Cirujano Mayor Dr Cosme Argerich — Buenos Aires, Argentina
- Arsema — Ciudad de Buenos Aires, Argentina
- Centro Medico Privado de Reumatologia Tucuman — Ciudad de San Miguel de Tucuman, Argentina
- Consultora Integral de Salud SRL — Córdoba, Argentina
- MR Medicina Reumatologica — San Fernando, Argentina
- Instituto Medico De Alta Complejidad (IMAC) — San Isidro, Argentina
- Ipswich Hospital — Ipswich, Australia
- Rheumatology Research Unit — Maroochydore, Australia
- BJC Health — Parramatta, Australia
- Queen Elizabeth Hospital — South Woodville, Australia
- Royal Darwin Hospital — Tiwi, Australia
- MC Medtech Services Ltd — Haskovo, Bulgaria
- Exacta Medica — Pleven, Bulgaria
- Medical Center Artmed — Plovdiv, Bulgaria
- Arthritis and Rheumatism Associates ARA Jonesboro — Jonesboro, Arkansas, United States
Full record on ClinicalTrials.gov
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