Health Condition 1: L405- Arthropathic psoriasis
Conditions
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must have been previously treated with 1 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 (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. 4. 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 5. Have active plaque psoriasis with at least one psoriatic plaque of greater than and equal to 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 4. 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 Achieve an American College of Rheumatology ACR 20 Response at Week 16.Timepoint: Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16 MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures: tender joint count less than or equal to 1; swollen joint count less than or equal to 1; psoriasis activity and severity index less than or equal to 1 or body surface area less than or equal to 3, patient pain VAS score of less than or equal to 15, patient global disease activity VAS (arthritis and psoriasis) score of less than or equal to 20, health assessment questionnaire (HAQ) score less than or equal to 0.5, and tender entheseal points less than or equal to 1.Timepoint: Week 16;Proportion of Participants Who Achieve Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to 3 Percent and an IGA Score of Greater Than Equal to 2 at BaselineTimepoint: Week 16;Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at BaselineTimepoint: Week 16;Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at BaselineTimepoint: Week 16;Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And Greater Than Equal to 2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at BaselineTimepoint: Week 16.;Proportion of Participants who Achieve an ACR 50 Response at Week 16. The ACR 50 responders are participants with an improvement of Greater Than Equal to 50 percent from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patients asses | — |
Countries
Argentina, Brazil, Bulgaria, Canada, China, Denmark, Germany, Hong Kong, Hungary, India, Italy, Japan, Mexico, Poland, Romania, Spain, Taiwan, Thailand, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Innovative medicine Johnson and Johnson Pvt Ltd.
Outcome results
None listed