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Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies.
Source: takeda.com
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Takeda announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO) Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-treat, high-impact sites, including the scalp, nails, palms and soles, compared with placebo.
These data build on the topline results from the Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled LATITUDE PsO 3001 and 3002 studies. In those studies, about 70% of patients treated with zasocitinib achieved static Physician Global Assessment (sPGA) 0/1 (clear or almost clear skin) at week 16, with a significantly greater Psoriasis Area and Severity Index (PASI) 75 response rate seen as early as week 4 and continuing to increase through week 24. The totality of data shows the potential of zasocitinib to deliver rapid and durable skin clearance — even in the hardest-to-treat areas.
“Psoriasis is a complex, heterogeneous disease that can present differently across patients and over time, particularly in high-impact sites that are often difficult to treat,” said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. “TYK2 plays a key role in regulating core disease-driving immune pathways, including the IL-23/IL-17 axis and type I interferon, which contribute to variability in disease presentation and treatment response. Our Phase 3 results reinforce the potential of our next-generation TYK2 inhibitor to deliver rapid, durable and consistent skin clearance in a convenient once-daily pill.”
The 3001 and 3002 studies also evaluated patients who had nail psoriasis, or patients with at least moderate scalp or palmoplantar psoriasis, at baseline.2 Results were consistent across the body, including these difficult-to-treat, high-impact sites:
- Scalp: 77% and 74% of patients with scalp psoriasis treated with zasocitinib achieved scalp-specific PGA (ssPGA) 0/1 response versus placebo (7% and 13%; p<0.001) and apremilast (42% and 30%; p<0.001) at week 16.
- Palms and soles (palmoplantar): Approximately 70% of patients with palmoplantar psoriasis treated with zasocitinib achieved numerically higher rates of hands and/or feet-specific PGA (hfPGA) 0/1 response (71% and 69%) versus placebo (22% and 10%) and apremilast (44% and 43%) at week 16.
- Nails: Zasocitinib also delivered statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo at week 16 (p<0.001).
- Responses were sustained through week 24 in both studies.
- The most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals identified.
Takeda plans to submit a New Drug Application for plaque psoriasis with the United States Food and Drug Administration and other regulatory authorities beginning this fiscal year. Zasocitinib is also being evaluated in Phase 3 studies in psoriatic arthritis
Source: takeda.com