A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)

Psoriatic Arthritis

ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16.

1. Key Secondary endpoint : Zasocitinib Dose A vs. Placebo • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. • PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16., 2. Key Secondary endpoint: ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. • Change from baseline in the HAQ-DI score at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16., 3. Key Secondary endpoint: Change from baseline in the SF-36 v2.0 PCS score at Week 16. • Change from baseline in the FACIT-Fatigue score at Week 16., 4. Key Secondary endpoint: Zasocitinib Dose B vs. Placebo • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. • ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16., 5. Key Secondary endpoint: Change from baseline in the HAQ-DI score at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16., 6. Key Secondary endpoint: PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16., 7. Key Secondary endpoint: Zasocitinib Dose A vs. active comparator • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16. • PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16., 8. Key Secondary endpoint: Zasocitinib Dose B vs. active comparator • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16., 1. Zasocitinib Dose A vs. Placebo Zasocitinib Dose B vs. Placebo • Enthesitis resolution in subjects with enthesitis at baseline (LEI >0): Assessed as proportion of subjects meeting LEI=0 at Week 16. • Change from baseline in individual components of ACR response at Week 16., 2. • Dactylitis resolution in subjects with dactylitis (LDI Basic >0) at baseline: Assessed as proportion of subjects meeting LDI Basic=0 at Week 16. • PASI75 response (in subjects with ≥3% BSA at baseline) at Week 4. • PASI75 response (in subjects with ≥3% BSA at baseline) at Week 8., 3. PASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. • PASI100 response (in subjects with ≥3% BSA at baseline) at Week 16., 4. ACR50 and PASI100 response (in subjects with ≥3% BSA at baseline): Assessed as proportion of subjects simultaneously achieving ACR50 and PASI100 at Week 16., 5. sPGA 0/1 response (in subjects with baseline sPGA ≥2): Assessed as proportion of subjects achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline at Week 16., 6. HAQ-DI response: Assessed as proportion of HAQ-DI minimal clinically important differences responders (defined as achieving a clinically meaningful reduction of ≥0.35 from baseline) at Week 16. • Change from baseline in the SF-36 v2.0 MCS score at Week 16., 7. Change from baseline in PsAID-12 total score at Week 16. • Change from baseline in DAPSA score at Week 16., 8. Change from baseline in DAS28[CRP] score at Week 16. • Change from baseline in PGA-F score in subjects with psoriatic nail involvement (PGA-F>0) at baseline at Week 16., 9. Zasocitinib Dose B vs. Placebo • Change from baseline in the SF-36 v2.0 PCS score at Week 16. • Change from baseline in the FACIT-Fatigue score at Week 16., 10. Zasocitinib Dose A vs. active comparator Zasocitinib Dose B vs. active comparator • ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16., 11. PASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. • PASI100 response (in subjects with ≥3% BSA at baseline) at Week 16., 12. ACR50 and PASI100 response (in subjects with ≥3% BSA at baseline): Assessed as proportion of subjects simultaneously achieving ACR50 and PASI100 at Week 16. • MDA: Assessed as proportion of subjects achieving MDA status at Week 16., • Enthesitis resolution in subjects with enthesitis (SPARCC Enthesitis Index >0) at baseline: Assessed as proportion of subjects meeting SPARCC Enthesitis Index=0 through Week 16. • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 8.

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