Zasocitinib (TAK-279), an investigational oral tyrosine kinase 2 (TYK2) inhibitor, achieved complete skin clearance at week 16 in 36.5% of adults with moderate to severe plaque psoriasis versus 13.9% with deucravacitinib in the phase 3 LATITUDE Atlas trial, Takeda announced at the European Academy of Dermatology and Venereology (EADV) Congress 2026.1,2
The results arrive as regulators in the US and Europe review zasocitinib for moderate to severe plaque psoriasis.1
"The data from the Phase 3 trials provide a more complete picture of once-daily oral zasocitinib, demonstrating rapid, durable and consistent skin clearance alongside meaningful improvements in itch and quality of life," said Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health in Detroit and principal investigator for LATITUDE Atlas.
Zasocitinib vs deucravacitinib efficacy in the LATITUDE Atlas trial
LATITUDE Atlas (NCT06973291; TAK-279 PsO 3004) is a randomized, multicenter, double-blind phase 3 trial enrolling 606 adults with moderate to severe plaque psoriasis. Participants received zasocitinib 30 mg once daily or deucravacitinib 6 mg once daily through week 16, followed by a 4-week safety follow-up. The primary endpoint was the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 100 at week 16.1
Zasocitinib met the primary endpoint, with 36.5% of patients (n = 301) achieving PASI 100 at week 16 compared with 13.9% of those receiving deucravacitinib (n = 303; P < .001).2
According to Takeda, higher rates of complete skin clearance with zasocitinib emerged as early as week 8, and more than 2.5 times as many zasocitinib-treated patients reached PASI 100 at week 16.1
Zasocitinib also demonstrated statistical superiority over deucravacitinib across all key secondary efficacy endpoints.2 At week 16, 62.5% of zasocitinib-treated patients achieved PASI 90 versus 34.0% of deucravacitinib-treated patients (P < .001). A static Physician Global Assessment (sPGA) score of 0 was reached by 43.2% and 18.5% of patients, respectively (P < .001).2
Zasocitinib Durability, Patient-Reported Outcomes, and Safety in Plaque Psoriasis
Long-term analyses from the pivotal phase 3 LATITUDE PsO 3001 (N = 693) and 3002 (N = 1108) trials, also presented at EADV, showed durable skin clearance with zasocitinib through week 52.3
Among week 24 responders, up to 93% maintained their response through week 52 in LATITUDE PsO 3001, a post hoc analysis, and through week 40 in LATITUDE PsO 3002.3
Zasocitinib-treated patients in both pivotal trials reported improvements in itch and quality of life as early as week 2, with continued gains through week 24.1 At week 2, reductions in weekly mean Psoriasis Symptoms and Signs Diary (PSSD) symptom scores, including itch, were greater with zasocitinib than with placebo (nominal P < .001) and, in LATITUDE PsO 3002, apremilast (nominal P < .05).
By week 4, more zasocitinib-treated patients achieved a Dermatology Life Quality Index (DLQI) score of 0/1 versus placebo and, in LATITUDE PsO 3002, versus apremilast.1
Zasocitinib was generally well tolerated in LATITUDE Atlas, with no new safety signals identified, according to Takeda.1 The most common adverse events across the phase 3 LATITUDE psoriasis program were upper respiratory tract infection, nasopharyngitis, and acne.1
"Across our Phase 3 trials, zasocitinib demonstrated superiority versus two distinct oral therapeutic classes in addition to rapid, durable and consistent skin clearance across patient types and in high-impact, hard-to-treat areas," said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit, Takeda.
The FDA accepted Takeda's new drug application for zasocitinib in moderate to severe plaque psoriasis under priority review in September 2026, and the European Medicines Agency is also reviewing the agent.1,4 Takeda is additionally evaluating zasocitinib in phase 3 trials in psoriatic arthritis and phase 2 trials in Crohn disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa.1
References
Takeda. Zasocitinib delivered superior efficacy versus deucravacitinib in new phase 3 head-to-head results, reinforcing potential to deliver rapid and durable skin clearance in a convenient once-daily pill. Published September 30, 2026. Accessed September 30, 2026. https://www.businesswire.com/news/home/20260929022019/en/
Stein Gold L, Reich A, Toth D, et al. Zasocitinib, a highly selective, once-daily oral TYK2 inhibitor, demonstrates superior skin clearance (PASI 100) versus an approved oral TYK2 inhibitor, deucravacitinib, and a consistent safety profile in moderate-to-severe plaque psoriasis: results from a randomized phase 3 intraclass head-to-head trial (LATITUDE Atlas). Presented at: European Academy of Dermatology and Venereology Congress 2026; September 30-October 3, 2026; Vienna, Austria.
Armstrong AW, Stein Gold L, Bunick CG, et al. Zasocitinib, a highly selective, once-daily oral TYK2 inhibitor, demonstrates durable efficacy for up to 60 weeks in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002). Presented at: European Academy of Dermatology and Venereology Congress 2026; September 30-October 3, 2026; Vienna, Austria.
