New Topline Phase 3 Data on Zasocitinib in Psoriasis, With Melinda Gooderham, MD

An announcement was released on December 18 highlighting Takeda’s new positive topline findings from two pivotal phase 3 studies on zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis.1,2

Zasocitinib, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, demonstrated superiority to placebo in the 2 studies’ co-primary endpoints: patients’ static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 scores.1 To discuss the data, HCPLive spoke with Melinda Gooderham, MD, dermatologist and medical director of the SKiN Centre for Dermatology in Ontario, Canada.

“They're the 2 duplicate, sister studies looking at zasocitinib, which is in highly selective TYK-2 inhibitor, with both placebo and [they’re] active comparator-controlled,” Gooderham explained.

Gooderham described the Latitude studies as 2 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies. Both were conducted in 21 countries and involved the recruitment of 693 and 1108 participants, respectively. The studies’ co-primary endpoints were determined to be the proportion of treated patients attaining sPGA 0/1 and PASI 75 response versus placebo at the 16-week mark.

Among the key secondary endpoints, Gooderham highlighted comparisons with placebo at Week 16 and apremilast at Weeks 16 and 24. Overall, she described the studies as having demonstrated the superiority of zasocitinib versus placebo for the co-primary endpoints. There had been a significantly greater number of PASI 75 responses observed as early as the 4-week mark and continuing to rise through to Week 24.

In Takeda’s announcement, all 44 ranked secondary endpoints were described as having been met, including sPGA 0, PASI 90, and PASI 100, against placebo and apremilast.1 The drug was generally well tolerated, and its safety findings were consistent with previous research. Gooderham noted the value of a once-daily oral agent delivering complete skin clearance for individuals living with psoriasis.

“I think what's exciting is that we're seeing these levels of biologic efficacy,” Gooderham said. “In the past has been a bit of a trade-off with our oral therapies being a little less effective than the biologics.”

In Takeda’s release, the most commonly seen adverse events (AEs) through the 24-week mark were noted as upper respiratory tract infection, acne, and nasopharyngitis.1 No new safety signals were identified by the investigators.

As stated in a prior HCPLive release, these data are slated to be presented during upcoming medical congresses. Additionally, Takeda plans to submit a New Drug Application to the US Food and Drug Administration (FDA) along with other regulatory authorities in 2026.2

The quotes contained in this summary were edited for the purposes of clarity.

Gooderham’s has reported nonfinancial support from Takeda in addition to personal fees from AbbVie, Amgen, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Meiji, Dermavant, Moonlake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Tarsus, Takeda, UCB, Union, Ventyx, and Apogee.

References

1. Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment. Takeda. December 18, 2025. Accessed January 10, 2026. https://www.takeda.com/newsroom/newsreleases/2025/takeda-zasocitinib-phase-3-plaque-psoriasis-data-once-daily-pill/.

2. Brooks A. Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis. HCPLive. December 18, 2025. Accessed January 10, 2026. https://www.hcplive.com/view/once-daily-oral-zasocitinib-delivers-strong-phase-3-efficacy-in-plaque-psoriasis.