The purpose of this research study is to determine the effectiveness of adding deucravacitinib to the participant's current Psoriatic Arthritis (PsA) treatment to see if it improves their symptoms and quality of life.
This study is exploring a new treatment approach that may help improve control of psoriatic disease by targeting different parts of the disease process. By combining therapies that work together, the goal is to offer better symptom relief with fewer or more manageable side effects than some current treatments.
Adults aged 18-65 with confirmed psoriatic arthritis based on CASPAR criteria.
Ability to provide informed consent and comply with study procedures.
Patients with plaque psoriasis BSA>3% OR PsA with [SJC>2 AND TJC >3] despite stable background anti-TNF therapy for at least 6 months, with or without csDMARDs (i.e MTX, leflunomide, sulfasalazine, hydroxychloroquine).
If on csDMARD (methotrexate [MTX], sulfasalazine [SSZ], leflunomide [LEF], hydroxychloroquine [HCQ]), the participant must have been on it for at least 12 weeks and be on a stable dose for at least 28 days prior to Day 1.
History of failure of more than two anti-TNF therapies, prior history of failure of TYK2 and JAK inhibitors.
History of prior allergic reaction or intolerance to deucravacitinib.
History of primary failure of anti-IL17, anti-IL23 is excluded. Note that prior exposure to these agents is allowed for reasons other than primary failure, eg intolerance, insurance / access issues, etc).
Systemic agents other than anti-TNF or csDMARD (ie. MTX, leflunomide, sulfasalazine, hydroxychloroquine) must have ceased > 6 months prior to baseline.
Parallel
Deucravacitinib
DrugDrug will be administered in tablet form.
Placebo
DrugDrug will be administered in tablet form.
Proportion of patients achieving a novel composite endpoint of BSA </= 1 AND SJC </= 1) OR (BSA </= 1 AND TJC </= 1) at 24 weeks
Proportion of patients achieving a novel composite endpoint of BSA \</= 1 AND SJC \</= 1) OR (BSA \</= 1 AND TJC \</= 1) at 24 weeks
Safety and tolerability, measured through adverse event reporting at baseline and weeks 5, 12, 24, and 48.
Safety and tolerability, measured through adverse event reporting at baseline and weeks 5, 12, 24, and 48.
Proportion of patients achieving Minimal Disease Activity (5/7 criteria) at weeks 24 and 48
Reaching Minimal Disease Activity involves achieving 5 of 7 criteria. The 7 criteria include less than or equal to 1 tender joint count, patient global assessment of disease activity via Visual Analog Scale of less than or equal to 20, less than or equal to 1 swollen joint count, tender entheseal points of less than or equal to 1, Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %, patient pain via Visual Analog Scale of less than or equal to 15, and Health Assessment Questionnaire - Disability Index of less than or equal to 0.5. The Minimal Disease Activity assessment will be done at weeks 24 and 48.
Proportion of patients achieving Very Low Disease Activity (7/7 criteria) at weeks 24 and 48
Very Low Disease Activity involves achieving 7 of 7 criteria. The 7 criteria include less than or equal to 1 tender joint count, patient global assessment of disease activity via Visual Analog Scale of less than or equal to 20, less than or equal to 1 swollen joint count, tender entheseal points of less than or equal to 1, Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %, patient pain via Visual Analog Scale of less than or equal to 15, and Health Assessment Questionnaire - Disability Index of less than or equal to 0.5. The Very Low Disease Activity assessment will be done at weeks 24 and 48.
Proportion of patients achieving Minimal Disease Activity - Skin (MDA with skin domain met) at weeks 24 and 48
Minimal Disease Activity - Skin is determined by a Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %. The Minimal Disease Activity - Skin assessment will be done at weeks 24 and 48.
Leed's enthesitis (resolution) BL at weeks 24 and 48
Leed's enthesitis (resolution) BL at weeks 24 and 48
Widespread pain index at baseline and at weeks 24 and 48
Widespread pain index at baseline and at weeks 24 and 48
International Dermatology Outcome Measure Musculoskeletal Questionnaire instrument (instrument validation) at baseline and at weeks 12, 24 and 48
International Dermatology Outcome Measure Musculoskeletal Questionnaire instrument (instrument validation) at baseline and at weeks 12, 24 and 48
Cardiometabolic biomarker evaluation at baseline, week 24 and week 48
Cardiometabolic biomarker evaluation includes tests for lipids, glycoprotein acetylation, fasting glucose, insulin levels, hemoglobin A1c, C-Reactive Protein, homeostatic model assessment for insulin resistance. These tests will be done at baseline, week 24 and week 48
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