Takeda reported phase 3 data showing zasocitinib achieved higher week 16 PASI 100 responses than deucravacitinib in plaque psoriasis.
Takeda reported topline results from LATITUDE Atlas, a phase 3 head-to-head study in adults with moderate-to-severe plaque psoriasis, showing zasocitinib was statistically superior to deucravacitinib for complete skin clearance at week 16.1 Zasocitinib, also known as TAK-279, is an investigational once-daily oral tyrosine kinase 2 (TYK2) inhibitor and is not approved by any regulatory authority.
“In this head-to-head study, zasocitinib clearly demonstrated superior skin clearance compared with deucravacitinib, highlighting clinically meaningful differences within the oral treatment class,” Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health and principal investigator for LATITUDE Atlas, said in the company announcement.1
LATITUDE Atlas (TAK-279-PsO-3004; NCT06973291) was designed as a randomized, multicenter, double-blind trial comparing zasocitinib 30 mg once daily with deucravacitinib 6 mg once daily in 606 adults with moderate-to-severe plaque psoriasis.1,2 Participants received assigned therapy through week 16, with total study participation of up to 25 weeks, including screening and safety follow-up. The primary end point was the proportion of participants achieving Psoriasis Area and Severity Index (PASI) 100 response at week 16.2
According to Takeda, zasocitinib met the primary end point and was statistically superior to deucravacitinib for PASI 100 at week 16. The company also reported superiority for key secondary end points, including PASI 90 response and Static Physician’s Global Assessment (sPGA) score of 0 at week 16. In the announcement, Takeda stated more than 35% of zasocitinib-treated patients achieved PASI 100 at week 16, a response rate described as more than 2.5 times that observed with deucravacitinib. Separation from the deucravacitinib response curve was reported as early as week 8.1
Safety details were limited in the topline release. Takeda described zasocitinib as generally well tolerated, with a safety and tolerability profile consistent with prior observations and no new safety signals identified. The company did not provide rates of adverse events, serious adverse events, discontinuations, laboratory abnormalities, infections, or other events of clinical interest in the announcement.1
Key Facts
The findings add to an expanding TYK2 inhibitor landscape in psoriasis. TYK2 is involved in signaling pathways relevant to psoriasis pathogenesis, including interleukin 23 and type I interferon pathways. Zasocitinib is being developed as a selective allosteric TYK2 inhibitor; in a previously published randomized phase 2b trial in moderate-to-severe plaque psoriasis, once-daily zasocitinib demonstrated greater PASI responses than placebo across evaluated doses, with dose-related efficacy and no clear signal of laboratory changes typically associated with broader Janus kinase inhibition reported in that study.3
Deucravacitinib, the active comparator in LATITUDE Atlas, is an approved oral TYK2 inhibitor for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.4 Its approval established TYK2 inhibition as an oral, targeted option distinct from older oral systemic treatments such as methotrexate, cyclosporine, acitretin, and apremilast, and separate from injectable biologics targeting tumor necrosis factor, interleukin 17, interleukin 23, or interleukin 12/23 pathways.
Clinically, a head-to-head trial against an approved oral TYK2 inhibitor is more informative than placebo-controlled data alone, particularly for physicians weighing oral options for patients who prefer to avoid injections or who are not candidates for biologics. However, the magnitude and durability of benefit will require review of the full data set, including baseline disease characteristics, subgroup responses, patient-reported outcomes, durability beyond 16 weeks, and comparative safety.
Takeda said it plans to present detailed LATITUDE Atlas data at upcoming medical meetings and remains on track to submit a new drug application for plaque psoriasis to the US Food and Drug Administration and other regulatory authorities beginning this fiscal year. Until then, zasocitinib remains investigational, and the topline results should be interpreted as preliminary pending peer-reviewed presentation or publication.1
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