- LATITUDE PsO 3001/3002 (Phase 3): zasocitinib achieved sPGA 0/1 in 71.4% and 69.2% at week 16; PASI90 in 61.3% and 51.9%; PASI100 in 33.4% and 25.2%.
- Rapidity and durability: PASI75 was significantly higher vs placebo by week 4 in study 3002 (16.8% vs 4.3%), and >90% of patients who responded at week 40 and stayed on treatment maintained response at week 60.
- Safety and development: TEAEs through week 16 were 62.1% for zasocitinib vs 46.9% placebo (serious TEAEs 3.0%); common AEs included URTI 10.1%, nasopharyngitis 6.2% and acne 6.5%; TAK-279 is an investigational, highly selective oral TYK2 inhibitor (>1,000,000-fold selectivity) with NDA submissions planned from FY2026.
Phase 3 studies
Two randomized, double-blind, placebo- and active comparator-controlled Phase 3 trials (LATITUDE PsO 3001 and 3002) enrolled 693 and 1,108 adults with moderate-to-severe plaque psoriasis across 21 countries; co-primary endpoints were sPGA 0/1 and PASI75 at week 16.
Efficacy results
Zasocitinib delivered rapid and durable skin clearance: sPGA 0/1 at week 16 was 71.4% and 69.2% (placebo 10.7% and 12.6%; apremilast 32.1% and 29.7%); PASI90 rates were 61.3% and 51.9% (placebo 5.0% and 4.0%; apremilast 16.8% and 15.9%); PASI100 reached 33.4% and 25.2% (placebo 0.7% and 1.1%; apremilast 2.9% and 4.3%); responses continued to increase through week 24. Rapidity shown in study 3002 with PASI75 at week 4: 16.8% vs 4.3% for placebo. Among patients who responded at week 40 and stayed on treatment, over 90% maintained response at week 60.
Safety
Through week 16, treatment-emergent adverse events occurred in 62.1% of zasocitinib-treated patients versus 46.9% placebo and 50.5% apremilast; serious TEAEs were 3.0% for zasocitinib, <1% placebo and 1.5% apremilast; most common AEs (≥5%) were upper respiratory tract infection (10.1%), nasopharyngitis (6.2%) and acne (6.5%); no new safety signals were identified relative to prior studies.
Development and mechanism
Zasocitinib (TAK-279) is an investigational oral TYK2 inhibitor with >1,000,000-fold selectivity for TYK2 over other JAKs; Takeda plans regulatory submissions starting in fiscal year 2026 and is evaluating additional head-to-head and Phase 3 programs in related indications.
