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A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis

Trial number: 2024-512496-12-00
Overall trial status: Ongoing, recruitment ended
Trial title: A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Czechia:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Latvia:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended, Bulgaria:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, France:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Incidence of treatment-emergent adverses events (TEAEs), Incidence of serious adverse events (SAEs)
Secondary end point: Over the duration of the study: ≥75% improvement in Psoriasis Area and Severity Index (PASI-75), Over the duration of the study: Static Physician Global Assessment (sPGA) of clear (0) or almost clear (1) with a ≥2-point decrease from baseline
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 839
Sponsor: Takeda Development Center Americas Inc.
Sponsor type: Pharmaceutical company
Trial product: ZASOCITINIB
Results posted: No
Overall decision date: 16/01/2025
Countries decision date: HU: 17/01/2025, IT: 17/01/2025, DE: 20/01/2025, FR: 28/07/2025, ES: 20/01/2025, LV: 16/01/2025, BG: 21/01/2025, CZ: 17/01/2025, PL: 21/01/2025
Last updated date: 29/05/2026

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