Takeda Pharmaceutical Company (4502) Study Update summary

Study design and methodology

• Two pivotal phase III studies (Latitude PsO 3001 and 3002) evaluated zasocitinib in adults with moderate-to-severe plaque psoriasis, using randomized, double-blind, placebo- and apremilast-controlled designs.

• Co-primary endpoints were sPGA 0/1 and PASI 75 at week 16; secondary endpoints included comparisons to apremilast, longer-term efficacy, and quality of life measures.

• Study 3001 enrolled ~690 patients (3:1:1 zasocitinib:apremilast:placebo); study 3002 enrolled >1,100 patients (2:1:1 ratio).

• Eligibility required adults with plaque psoriasis for ≥6 months, PASI ≥12, sPGA ≥3, and ≥10% BSA.

• In study 3002, patients achieving PASI 75 at week 40 entered a randomized withdrawal phase to assess durability of response.

Efficacy results

• Both studies met all co-primary and ranked secondary endpoints, with zasocitinib showing rapid and durable efficacy, outperforming placebo and apremilast.

• At week 16, sPGA 0/1 was achieved by 71–74% and PASI 75 by 76–77% of zasocitinib patients, versus 11–13% and ~12% for placebo.

• Rapid onset observed, with significant differences from placebo as early as week 4 for PASI 75 and sPGA 0/1.

• By week 24, up to 69% achieved PASI 90, up to 49% achieved clear skin (sPGA 0), and up to 42% achieved PASI 100.

• Over 90% of patients continuing zasocitinib at week 40 maintained sPGA 0/1, PASI 75, and PASI 90 through week 60.

Quality of life

• Quality of life improved rapidly, with up to 60% of patients reporting DLQI 0/1 by week 24.

• Efficacy continued to improve between weeks 16 and 24, with clear superiority over apremilast.