Health Condition 1: L405- Arthropathic psoriasis
Conditions
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion 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 per 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 greater than or equal to 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants who Achieve an American College of Rheumatology ACR 20 ResponseTimepoint: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 assessment of pain VAS, patients global assessment of disease activity VAS scale, physicians global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).Timepoint: Week 16;Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16. The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0-no difficulty and 3-inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 - least difficulty and 3 - extreme difficulty.Timepoint: From baseline to Week 16;Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains are averaged to calculate PCS. Total score range for PCS is 0-100 (100-highest level of physical functioning).Timepoint: From baseline to Week 16;Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enth | — |
Countries
Argentina, Australia, Bulgaria, China, Denmark, Germany, Hong Kong, Hungary, India, Japan, Poland, Spain, Taiwan, Thailand, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Private Limited
Outcome results
None listed