Takeda's Zasocitinib Beats Deucravacitinib Head-to-Head in Phase 3 Psoriasis Trial, More Than Doubling Complete Skin Clearance
In the LATITUDE Atlas trial, more than 35% of patients on Takeda's oral TYK2 inhibitor reached completely clear skin at week 16 — more than 2.5 times the rate seen with Bristol Myers Squibb's deucravacitinib.
Overview
Takeda reported on June 11 that its investigational oral drug zasocitinib outperformed deucravacitinib, an already-marketed drug in the same class, in a head-to-head Phase 3 plaque psoriasis trial. More than 35% of patients treated with zasocitinib achieved completely clear skin at week 16 — more than 2.5 times the response rate recorded for deucravacitinib, according to BioSpace, which carried the company’s announcement.
The result is notable because both drugs are oral tyrosine kinase 2 (TYK2) inhibitors — a comparatively new class of pills that targets an enzyme central to the immune signaling behind psoriasis. Direct head-to-head trials between competing drugs in the same class are uncommon in dermatology, where most pivotal studies measure a new drug against placebo.
What We Know
The trial, named LATITUDE Atlas (TAK-279-PsO-3004), was a Phase 3, randomized, multicenter, double-blind study, BioSpace reported. It enrolled 606 participants and compared zasocitinib at 30 mg once daily against deucravacitinib at 6 mg once daily over a 16-week treatment period.
The primary endpoint was complete skin clearance, measured as a PASI 100 response — a 100% reduction on the Psoriasis Area and Severity Index — at week 16. More than 35% of zasocitinib-treated patients reached that mark, more than 2.5 times the rate for deucravacitinib, per BioSpace. The drug also showed statistical superiority over deucravacitinib for all key secondary endpoints, including PASI 90 response and a Static Physician’s Global Assessment (sPGA) score of 0 at week 16. Separation from the deucravacitinib curve appeared as early as week 8, the same release noted.
On safety, Takeda said zasocitinib “was generally well tolerated with a consistent safety and tolerability profile and no new safety signals identified,” according to BioSpace.
Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health, said in the announcement: “In this head-to-head study, zasocitinib clearly demonstrated superior skin clearance compared with deucravacitinib, highlighting clinically meaningful differences within the oral treatment class,” BioSpace reported. Chinwe Ukomadu, MD, PhD, Senior Vice President and Head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda, added: “These head-to-head results build on the strong efficacy seen across our Phase 3 program, with more than 35% of zasocitinib-treated patients achieving complete skin clearance (PASI 100) at week 16.”
Takeda said it is on track to submit a New Drug Application for plaque psoriasis to the U.S. Food and Drug Administration and other regulatory authorities starting this fiscal year, the release stated.
Background: How Zasocitinib Got Here
LATITUDE Atlas follows an earlier pivotal Phase 3 program in which zasocitinib was tested against placebo and the oral comparator apremilast. In those two randomized, double-blind studies, 61.3% and 51.9% of zasocitinib-treated patients achieved PASI 90 at week 16, versus 5.0% and 4.0% on placebo, BioSpace reported. For complete clearance, 33.4% and 25.2% of zasocitinib patients reached PASI 100, against 0.7% and 1.1% on placebo. Responses emerged quickly, with 16.8% of zasocitinib patients hitting PASI 75 by week 4 compared with 4.3% on placebo, the same source noted.
Takeda has framed zasocitinib’s appeal partly on selectivity: the molecule has “more than 1-million-fold greater selectivity for TYK2 compared to other JAK enzymes,” according to BioSpace. High selectivity for TYK2 is intended to dampen the inflammatory signaling that drives psoriasis without hitting the related JAK1, JAK2 and JAK3 pathways.
The drug came to Takeda through acquisition. Takeda acquired zasocitinib from Nimbus Therapeutics for $4 billion at the end of 2022, BioSpace reported. Its head-to-head comparator, deucravacitinib, is marketed by Bristol Myers Squibb under the brand name Sotyktu.
What We Don’t Know
Takeda’s announcement was a topline release. The exact PASI 100 figure for the deucravacitinib arm was not disclosed beyond the “more than 2.5 times” comparison, and detailed adverse-event rates, discontinuation numbers, and the full secondary-endpoint breakdown were not provided. Those details typically follow at a medical congress or in a peer-reviewed publication.
The filing timeline also leaves open questions. Takeda said only that it expects to begin regulatory submissions this fiscal year; it did not specify a target action date or how it would position zasocitinib against an entrenched, already-approved rival on price and access.
Analysis
The strategic logic of running a head-to-head trial is straightforward: a new entrant in an established class needs a differentiation argument, and beating the incumbent on its own primary measure is the strongest one available. The oral psoriasis segment is projected to exceed $5 billion by 2030, BioSpace reported, and oral pills compete not only with each other but with highly effective injectable biologics that many patients would prefer to avoid.
Analysts had already taken note of the broader program. Jefferies characterized zasocitinib’s earlier Phase 3 data as “best-in-class Ph3 results” with the “potential to redefine the oral psoriasis market,” BioSpace reported. A head-to-head win over an established drug in the class strengthens that case ahead of an FDA filing — though regulators evaluate full datasets, not topline summaries, and the deucravacitinib arm’s performance will draw scrutiny once detailed numbers are published.