Zasocitinib Shows High Skin Clearance at Hard-to-Treat Psoriasis Sites

Takeda recently announced new phase 3 data showing zasocitinib achieved high rates of skin clearance at hard-to-treat, high-impact psoriasis sites, including the scalp, nails, palms, and soles, in adults with moderate to severe plaque psoriasis. The secondary end point results, presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, come from the phase 3 LATITUDE PsO 3001 (NCT06671483) and 3002 trials (NCT06671496).¹ On average, about 75% of patients with scalp psoriasis and approximately 70% of patients with palmoplantar disease treated with zasocitinib achieved clear or almost clear skin at week 16.^1-3

These findings build on topline results from the LATITUDE PsO studies, in which about 70% of patients treated with zasocitinib achieved static Physician Global Assessment (sPGA) 0/1 at week 16, with significantly higher Psoriasis Area and Severity Index (PASI) 75 response rates than placebo starting at week 4.^1,3 Scalp, palmoplantar, and nail involvement each affect a substantial subset of patients with plaque psoriasis and often respond less predictably to systemic therapy than other body sites. Takeda plans to submit a New Drug Application for zasocitinib in plaque psoriasis to the FDA and other regulatory authorities beginning this fiscal year.¹

LATITUDE PsO 3001 and 3002 are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 3 trials evaluating zasocitinib, an investigational, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate to severe plaque psoriasis. The trials enrolled 693 and 1108 participants, respectively, across 21 countries. Co-primary end points were the proportion of zasocitinib-treated patients achieving sPGA 0/1 and PASI 75 response versus placebo at week 16.⁴

Ranked secondary end points included comparisons versus placebo at week 16 and versus apremilast (Otezla; Amgen) at weeks 16 and 24. Among these were response rates at scalp, palmoplantar, and nail sites, which are frequently difficult to clear with systemic therapy. Both trials assessed patients with at least moderate baseline involvement at each of these 3 high-impact sites.^1,2

“We're entering an era where we have better oral options, and with zasocitinib, we can offer patients an oral option that's once a day that's been shown to be effective. It has a known safety profile, it seems to be well tolerated, and we can have that conversation. In the past, we might not have offered a number of oral options, or maybe we didn't even offer an oral option. Now we can really broaden that conversation,” said Linda Stein Gold, MD, in a recent interview.

Zasocitinib High-Impact Site Efficacy and Safety Data

At week 16, 77% and 74% of patients with scalp psoriasis achieved scalp-specific Physician Global Assessment (ssPGA) 0/1 response with zasocitinib, versus 7% and 13% with placebo (P < .001) and 42% and 30% with apremilast (P < .001). Scalp involvement was assessed in 38% and 28% of the overall trial populations. Approximately 70% of patients with palmoplantar disease achieved hands and/or feet-specific PGA (hfPGA) 0/1 response (71% and 69%), compared with 22% and 10% for placebo and 44% and 43% for apremilast, in a subset representing 24% and 22% of participants.¹

Zasocitinib also produced statistically significant improvement in Nail Psoriasis Severity Index (NAPSI) scores versus placebo at week 16 (P < .001) among patients with baseline nail involvement, representing 37% and 30% of participants. Responses across all 3 high-impact sites were sustained through week 24 in both studies. According to Takeda, the most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis, and acne, with no new safety signals identified.¹

Leon Kircik, MD, founder and medical director of Skin Sciences and Physicians Skin Care in Louisville, Kentucky, and principal investigator for the LATITUDE PsO studies, said the data reinforce the potential of zasocitinib as a whole-body treatment option.

"These findings show that zasocitinib delivered consistently clear skin across the hardest-to-treat areas, including the scalp, nails, palms and soles, reinforcing its potential to become a leading oral treatment option for patients seeking meaningful, whole-body skin clearance," Kircik said in the news release.¹

Zasocitinib is also being evaluated in phase 3 trials for psoriatic arthritis and phase 2 trials for Crohn disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa. If approved, the oral, once-daily TYK2 inhibitor could give clinicians a nonbiologic option for patients whose psoriasis involves these hard-to-treat body regions.¹

References

1. Takeda's zasocitinib demonstrates consistent, high rates of skin clearance across the body, including hard-to-treat and high-impact sites, in phase 3 psoriasis studies. News release. Takeda. July 16, 2026. Accessed July 16, 2026.
2. Armstrong AW, et al. Zasocitinib, a once-daily oral TYK2 inhibitor, demonstrates efficacy at high impact sites in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002). Presented at: 2026 American Academy of Dermatology Innovation Academy; July 16, 2026; New York, NY.
3. Gooderham M, et al. Once-daily oral zasocitinib demonstrates rapid and reproducible skin clearance with a consistent safety profile in moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002). Presented at: American Academy of Dermatology 2026; March 28, 2026; Denver, CO.
4. A study about how well TAK-279 works and its safety in participants with moderate-to-severe plaque psoriasis during 52 weeks of treatment. ClinicalTrials.gov identifier NCT06088043. Updated October 24, 2025. Accessed July 16, 2026. https://clinicaltrials.gov/study/NCT06088043.

Frequently Asked Questions

What is zasocitinib?
Zasocitinib (TAK-279) is an investigational, oral, once-daily tyrosine kinase 2 (TYK2) inhibitor being developed by Takeda for moderate to severe plaque psoriasis and several other immune-mediated conditions.

How did zasocitinib perform at high-impact psoriasis sites?
In the LATITUDE PsO 3001 and 3002 trials, zasocitinib achieved clear or almost clear skin at week 16 in about 75% of patients with scalp psoriasis and about 70% of patients with palmoplantar disease, with statistically significant improvement in nail psoriasis severity versus placebo.

What is next for zasocitinib?
Takeda plans to submit a New Drug Application for plaque psoriasis to the FDA and other regulatory authorities beginning this fiscal year.