A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naive Participants With Active Psoriatic Arthritis ( ICONIC-PsA 1 )

JRCT ID: jRCT2011240065

Registered date:20/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Arthritis, Psoriatic
• Date of first enrollment: 07/02/2025
• Target sample size: 540
• Countries of recruitment: Argentina,Japan,Australia,Japan,Bulgaria,Japan,China,Japan,Czechia,Japan,Denmark,Japan,Germany,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Poland,Japan,Spain,Japan,Taiwan Province Of China,Japan,Thailand,Japan,United States Of America,Japan
• Study type: Interventional

Intervention(s)

-Group I: Icotrokinra Dose 1:Participants will receive icotrokinra dose 1.Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
-Group II: Icotrokinra Dose 2:Participants will receive icotrokinra dose 2.Participants who continue into a LTE will continue to receive icotrokinra dose 2.
-Group III: Placebo:Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
-Group IV: Active Reference Comparator:Participants will receive active reference drug, ustekinumab. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.

Outcome(s)

• Primary Outcome: 1.Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16:The ACR 20 responders are participants with an improvement of greater than or equal to (>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).[Time Frame: Week 16]
• Secondary Outcome: Refer to Appendix

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kano Yuya
• Secondary ID(s): 2023-509239-19-00