Overall trial status: Ended
Trial title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Poland:Ended, Italy:Ended, Germany:Ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Static Physician’s Global Assessment (sPGA) 0/1 response: 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., Psoriasis Area and Severity Index (PASI)-75 response: Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16.
Secondary end point: PASI Response: Proportion of subjects achieving PASI-75 (versus apremilast), PASI-90, or PASI-100 at Week 16 or Week 24., Enhanced sPGA response: Proportion of subjects achieving an sPGA of clear (0) at Week 16, Changes in severity of psoriasis on the scalp, nail, body surface area, hands and feet using ssPGA, NAPSI, BSA, and PGA of the hands and/or feet
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 235
Sponsor: Takeda Development Center Americas Inc.
Sponsor type: Pharmaceutical company
Trial product: Otezla 10mg, 20mg, 30 mg film-coated tablets, Otezla 10mg, 20mg, 30 mg film-coated tablets, Apremilast placebo (same excipient as over-encapsulated Otezla), Otezla 10mg, 20mg, 30 mg film-coated tablets, ZASOCITINIB, Otezla 30 mg film-coated tablets, TAK-279 placebo (same excipient as TAK-279)
Results posted: Yes
Overall decision date: 04/03/2024
Countries decision date: IT: 11/03/2024, DE: 16/04/2024, PL: 07/03/2024
Last updated date: 10/12/2025
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