AMBIGUOUS RESULTS

Zasocitinib clears scalp, nail and palm psoriasis at high rates in Takeda Phase 3 data

Secondary results from the LATITUDE PsO trials show Takeda's oral TYK2 inhibitor clearing hard-to-treat sites after topline data already met the sPGA primary endpoint against placebo.

Takeda disclosed secondary endpoint data from the Phase 3 LATITUDE PsO 3001 and 3002 trials showing zasocitinib cleared psoriasis at the scalp, nails, palms and soles at rates well above placebo, building on topline results that already met the sPGA primary endpoint.
Trial NCT06088043

Executive Summary

  • Takeda's oral TYK2 inhibitor zasocitinib cleared psoriasis at hard-to-treat body sites in a Phase 3 program that had already met its primary skin-clearance endpoint against placebo.
  • The disclosure adds secondary, site-specific results at the scalp, nails, palms and soles, sites that carry disproportionate quality-of-life impact and are typically harder to clear than the trunk or limbs.
  • Safety through six months of follow-up stayed consistent with prior data on the drug, with no new signals identified.
  • Zasocitinib enters an oral small-molecule field crowded with JAK1 inhibitors already approved or in late-stage testing across related inflammatory-skin indications, positioning this data as a differentiation argument on site-specific clearance rather than a novel-mechanism story.
  • Takeda is carrying this data toward a planned U.S. and international regulatory filing for plaque psoriasis beginning this fiscal year.

The data

Takeda Pharmaceutical Company Limited presented new secondary endpoint results from the two pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies of zasocitinib (TAK-279) at the 2026 American Academy of Dermatology Innovation Academy on July 16, 2026. The studies had already met their primary endpoint: about 71% and 69% of patients treated with zasocitinib achieved a static Physician's Global Assessment (sPGA) of clear or almost clear skin at Week 16, versus placebo, with p<0.001 in both trials. The new data extend that result into specific, hard-to-treat body sites rather than reporting a new primary readout. Takeda’s+1Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis StudiesJul 16, 2026A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of TreatmentNCT06088043

Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.

Endpoint Met100%
Completes99%
Clinical Significance76%
Regulatory54%

Site-specific results

At the scalp, 77% and 74% of patients with scalp psoriasis achieved a scalp-specific PGA (ssPGA) 0/1 response with zasocitinib across the two trials, compared with 7% and 13% on placebo and 42% and 30% on apremilast (p<0.001 for both comparisons). At the hands and feet, roughly 70% of patients with palmoplantar psoriasis reached a hands/feet-specific PGA 0/1 response (71% and 69%), against 22% and 10% on placebo and 44% and 43% on apremilast. Nail psoriasis severity, measured by NAPSI, improved against placebo with p<0.001. Takeda said these responses held through Week 24 in both studies. Takeda’sTakeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis StudiesJul 16, 2026

Safety and design

The LATITUDE PsO 3001 and 3002 studies were randomized, multicenter, double-blind trials controlled against both placebo and the active comparator apremilast, enrolling 693 patients in the NCT06088043 study with sites across the United States, China, Poland, South Korea, Japan, Canada, Italy and Taiwan. The most common adverse events through Week 24 were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals identified. That safety read is consistent with prior disclosures on the drug rather than a departure from them. NCT06088043+1A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of TreatmentNCT06088043Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis StudiesJul 16, 2026

Regulatory path

Takeda said it plans to submit a New Drug Application for plaque psoriasis to the FDA and other regulatory authorities beginning this fiscal year, alongside Health Canada filings. The trial itself completed on October 22, 2025, following a primary completion date of January 22, 2025, after an earlier registered date of August 15, 2025. Takeda’s+1Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis StudiesJul 16, 2026A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of TreatmentNCT06088043

Competitive position

Zasocitinib is a small molecule targeting JAK1 in a field where seven direct comparators, including AbbVie's upadacitinib, Pfizer's abrocitinib and Eli Lilly's baricitinib, are already in Phase 3 or Phase 4 testing across related inflammatory-skin and immune indications. Bristol-Myers Squibb's deucravacitinib, a TYK2 inhibitor like zasocitinib but targeting a different receptor pathway within the JAK family, is running its own Phase 3 program in plaque psoriasis. Against that backdrop, this readout functions as a differentiation argument on depth of clearance at specific body sites rather than a claim to a novel mechanism, since JAK1/TYK2 inhibition in plaque psoriasis is already an established, multi-sponsor category.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.