Takeda: Zasocitinib achieves high, consistent clearance at hard-to-treat psoriasis sites

Phase 3 secondary endpoint findings

Secondary endpoint data from the LATITUDE PsO 3001 and 3002 trials show zasocitinib delivered high rates of skin clearance across difficult-to-treat, high-impact sites. Scalp-specific PGA (ssPGA) 0/1 at week 16 was 77% and 74% versus placebo (7% and 13%; p<0.001) and apremilast (42% and 30%; p<0.001). Palmoplantar (hfPGA) 0/1 rates at week 16 were approximately 71% and 69% versus placebo (22% and 10%) and apremilast (44% and 43%). Zasocitinib also achieved statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo at week 16 (p<0.001).

Durability and onset

Responses were sustained through week 24. Topline results from the same Phase 3 program reported about 70% of patients achieved static Physician Global Assessment (sPGA) 0/1 at week 16, and PASI 75 responses appeared as early as week 4 and continued to increase through week 24.

Safety profile

Through week 24 the most commonly reported adverse events were upper respiratory tract infection, nasopharyngitis and acne. The company reported no new safety signals in the presented data.

Study scope and regulatory plans

The two global, randomized, double-blind, placebo- and active-controlled LATITUDE studies enrolled 693 and 1,108 participants across 21 countries. Takeda plans to submit a New Drug Application for plaque psoriasis to the FDA and other regulatory authorities beginning this fiscal year. Zasocitinib is also in Phase 3 development for psoriatic arthritis and Phase 2 trials in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa.