Arthritis, Psoriatic Skin and Connective Tissue Diseases
Conditions
Interventions
This study is a 52-week main study with a 52-week blinded long-term extension (LTE). At Week 0, participants will be randomly (by chance) assigned to one of the 3 treatment arms:
Group I: icotrokinra
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/05/2026: 1. Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (>=) one of the following: 1.1. Non-biologic disease modifying antirheumatic drug (DMARD) therapy 1.2. Apremilast therapy 1.3. Biologic-agent (limited to only one) 2. 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. 3. Have active PsA as defined by: 3.1. At least three swollen joints and at least three tender joints at screening and at baseline. 3.2. C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory. 4. Have at least one 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. 5. Have active plaque psoriasis with at least one psoriatic plaque of >=2 cm diameter or nail changes consistent with psoriasis. 6. 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. Previous inclusion criteria: 1. Participants must have been previously treated with one biologic agent for psoriatic arthritis (PsA) or psoriasis and the reason for discontinuation must be documented. 2. 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. 3. Have active PsA as defined by: 3.1. At least three swollen joints and at least three tender joints at screening and at baseline. 3.2. C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory. 4. Have at least one 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. 5. Have active plaque psoriasis with at least one psoriatic plaque of >=2 cm diameter or nail changes consistent with psoriasis. 6. 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: 1. 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. 2. Currently has a malignancy or has a history of malignancy within 5 years prior to screening. 3. Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients. 4. 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. 5. Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator’s opinion, would have the potential to interfere with efficacy assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than or Equal to (>=) 3 Percent (%) and With Baseline IGA Score of >=2 2. Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 3. Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 4. Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 5. Proportion of Participants who Achieved an ACR 50 Response at Week 16 6. Proportion of Participants who Achieved an ACR 70 Response at Week 16 7. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16 8. Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 9. Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline 10. Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline 11. Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline 12. Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline 13. Proportion of Participants who Achieved Minimal Disease Activity (MDA) at Week 16 14. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Denmark, England, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Romania, Spain, Taiwan, Thailand, United Kingdom
Contacts
Public ContactJack Alden
Outcome results
None listed