Takeda's zasocitinib outperforms BMS's Sotyktu in Phase III plaque psoriasis trial

Takeda (TSE:4502/NYSE:TAK) has reported that zasocitinib demonstrated statistically significant superiority over Bristol Myers Squibb's Sotyktu (deucravacitinib) across all primary and key secondary endpoints in a Phase III head-to-head trial, with more than 35% of patients achieving complete skin clearance at week 16 — more than 2.5 times the rate observed with deucravacitinib. The result is the most consequential data readout in the oral psoriasis class since deucravacitinib's FDA approval in September 2022, and directly challenges the only currently approved oral TYK2 inhibitor in plaque psoriasis.

Trial data

The LATITUDE Atlas study (TAK-279-PsO-3004) is a Phase III, randomized, multicenter, double-blind trial that enrolled 606 adults with moderate-to-severe plaque psoriasis. Participants received zasocitinib 30 mg once daily or deucravacitinib 6 mg once daily for 16 weeks. The primary endpoint — PASI 100 response rate at week 16 — was met with statistical superiority for zasocitinib. Key secondary endpoints, including PASI 90 and static Physician's Global Assessment (sPGA) score of 0 at week 16, were also statistically superior. Separation from the deucravacitinib curve was detectable as early as week 8. The safety profile was consistent with previous zasocitinib studies, with no new signals identified.

These results build on earlier Phase III data from the LATITUDE PsO 3001 and 3002 studies, presented at the American Academy of Dermatology in April 2026, in which approximately 70% of zasocitinib-treated patients achieved clear or almost clear skin at week 16 versus roughly 30% for apremilast. The PASI 100 rate in LATITUDE Atlas exceeds the approximately 29%–32% complete clearance rates reported for BMS's deucravacitinib in its own pivotal trials, though cross-trial comparisons are limited by differences in patient populations, study designs, and endpoints.

Competitive context

The oral psoriasis landscape has become markedly more competitive in 2026. Johnson & Johnson's Icotyde (icotrokinra), an oral IL-23 receptor antagonist, received FDA approval in March 2026 and also demonstrated superiority to deucravacitinib in the Phase III ICONIC-ADVANCE studies, with approximately 70% of patients achieving IGA 0/1 at week 16. Both zasocitinib and icotrokinra are now positioned as potential successors to deucravacitinib within the oral class, though they act through distinct mechanisms — zasocitinib inhibits TYK2 allosterically via the pseudokinase domain, suppressing IL-23 and type I interferon signaling, while icotrokinra directly blocks the IL-23 receptor. The head-to-head superiority data for zasocitinib over deucravacitinib is analytically significant because it was generated in a controlled, blinded, randomized setting rather than through cross-trial inference, providing a cleaner basis for competitive differentiation. Alumis, developing ESK-001, another next-generation TYK2 inhibitor, remains in Phase III and has not yet reported comparative data.

Takeda has stated it is on track to submit a New Drug Application to the US FDA and other regulatory authorities beginning in fiscal year 2026. Zasocitinib is also in Phase III trials for psoriatic arthritis and Phase II studies across Crohn's disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa, suggesting the TYK2 program is central to Takeda's inflammation franchise strategy.

---

This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/

---

Spot something wrong? Report an issue with this article