Takeda Pharmaceutical Company Limited
(Correction) Partial correction regarding “Zasositinib for Plaque Psoriasis, Oral Once Daily Administration Shows Improvement in Skin Lesions and Possibility to Open a New Era of Treatment: Breakthrough Phase 3 Clinical Trial Data”
In the Phase 3 clinical trial of Zasositinib, the primary endpoints were achieved at week 16, with more than half of patients reaching PASI 90 and approximately 30% achieving PASI 100 indicating complete clearance of skin lesions. Safety profile was favorable.
Key Figures
- PASI 90 Achievement Rate: More than half (at week 16)
- PASI 100 Achievement Rate: Approximately 30% (at week 16)
- Number of Patients in Phase 3 Clinical Trials: 693 and 1108 cases (total for 2 trials)
AI要約
Regarding the Correction of Clinical Trial Results
A translation error was identified in the Phase 3 clinical trial data of Zasositinib published on 2025-12-18, requiring correction of descriptions comparing placebo and apremilast. After correction, superiority over placebo is still demonstrated in the primary endpoints at week 16, sPGA0/1 and PASI 75.
Phase 3 Clinical Trial Results of Zasositinib and Future Outlook
In an international joint Phase 3 study targeting moderate to severe plaque psoriasis patients, primary endpoints were achieved at week 16. More than half of patients attained PASI 90, and about 30% achieved PASI 100 indicating complete clearance of skin lesions, with effects lasting up to 24 weeks. The safety profile was favorable with no new safety signals observed. Applications for new drug approval will be submitted to regulatory authorities including the US FDA going forward.
