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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Key facts

Study ID

NCT06807424

Run by

Janssen Research & Development, LLC

People needed

750

Starts

2025-01-09

Expected to finish

2028-10-18

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 active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1)
• Have a diagnosis of 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) >= 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 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
• Currently has a malignancy or has a history of malignancy within 5 years prior to screening
• 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

• ARCIS Salud SRL Aprillus asistencia e investigacion — Buenos Aires, Argentina (enrolling)
• Arthritis and Rheumatism Associates ARA Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• AARA Clinical Research 1 — Mesa, Arizona, United States (enrolling)
• Instituto Medico De Alta Complejidad (IMAC) — Buenos Aires, Argentina (enrolling)
• Suncoast Clinical Research — New Port Richey, Florida, United States (enrolling)
• Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States (enrolling)
• Clinical Research of West Florida 1 — Tampa, Florida, United States (enrolling)
• Clinical Research of West Florida — Clearwater, Florida, United States (enrolling)
• AARA Clinical Research — Glendale, Arizona, United States (enrolling)
• Omega Research Consultants — DeBary, Florida, United States (enrolling)
• St Paul Rheumatology PA — Eagan, Minnesota, United States (enrolling)
• Albuquerque Rehabilitation and Rheumatology — Albuquerque, New Mexico, United States (enrolling)
• Joint and Muscle Research Institute — Charlotte, North Carolina, United States (enrolling)
• Rheumatology Associates of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States (enrolling)
• Clinical Research Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• UT Southwestern — Dallas, Texas, United States (enrolling)
• Arthritis and Rheumatology Research Institute — Frisco, Texas, United States (enrolling)
• Klein And Associates M D P A — Hagerstown, Maryland, United States (enrolling)
• AARA Clinical Research Lone Star Arthritis and Rheumatology — Irving, Texas, United States (enrolling)
• DM Clinical Research — Tomball, Texas, United States (enrolling)
• Velocity Clinical Research — Waco, Texas, United States (enrolling)
• Seattle Rheumatology — Seattle, Washington, United States (enrolling)
• Center of Rheumatic Diseases — Glendale, Wisconsin, United States (enrolling)
• Hospital Militar Central Cir. My. Dr. Cosme Argerich — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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