Arthritis, Psoriatic
Conditions
Interventions
Experimental: Group I: Icotrokinra Dose 1
Participants will receive icotrokinra Dose 1.Participants who have not discontinued will be eligible to enter a long term extension (LTE) and will continue to
Sponsors
Tamura Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Proportion of Participants who Achieved 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 [arthritis, VAS] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).[Time Frame: Week 16] | — |
Secondary
| Measure | Time frame |
|---|---|
| Refer to Appendix | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Germany, Hong Kong, Hungary, India, Italy, Japan, Malaysia, Mexico, Poland, Romania, Spain, Taiwan Province Of China, Thailand, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed