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

• On average, about 75% of patients with scalp psoriasis treated with zasocitinib achieved clear or almost clear skin at week 16
• Approximately 70% of patients with palmoplantar disease treated with zasocitinib achieved clear or almost clear skin at week 16
• Zasocitinib demonstrated statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo
• Results reinforce the potential of zasocitinib to deliver rapid and durable skin clearance, including in the hardest-to-treat areas, in a convenient once-daily pill

Takeda ((TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).¹ Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-treat, high-impact sites, including the scalp, nails, palms and soles, compared with placebo.^1-5

These data build on the topline results from the Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled LATITUDE PsO 3001 and 3002 studies.^2,6 In those studies, about 70% of patients treated with zasocitinib achieved static Physician Global Assessment (sPGA) 0/1 (clear or almost clear skin) at week 16, with a significantly greater Psoriasis Area and Severity Index (PASI) 75 response rate seen as early as week 4 and continuing to increase through week 24.⁶ The totality of data shows the potential of zasocitinib to deliver rapid and durable skin clearance — even in the hardest-to-treat areas.^2,6

"Psoriasis is a complex, heterogeneous disease that can present differently across patients and over time, particularly in high-impact sites that are often difficult to treat," said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. "TYK2 plays a key role in regulating core disease-driving immune pathways, including the IL-23/IL-17 axis and type I interferon, which contribute to variability in disease presentation and treatment response. Our Phase 3 results reinforce the potential of our next-generation TYK2 inhibitor to deliver rapid, durable and consistent skin clearance in a convenient once-daily pill."

Phase 3 psoriasis results across high-impact sites

The 3001 and 3002 studies also evaluated patients who had nail psoriasis, or patients with at least moderate scalp or palmoplantar psoriasis, at baseline.² Results were consistent across the body, including these difficult-to-treat, high-impact sites:^2-5

• Scalp: 77% and 74% of patients with scalp psoriasis treated with zasocitinib achieved scalp-specific PGA (ssPGA) 0/1 response versus placebo (7% and 13%; p<0.001) and apremilast (42% and 30%; p<0.001) at week 16.²
• Palms and soles (palmoplantar): Approximately 70% of patients with palmoplantar psoriasis treated with zasocitinib achieved numerically higher rates of hands and/or feet-specific PGA (hfPGA) 0/1 response (71% and 69%) versus placebo (22% and 10%) and apremilast (44% and 43%) at week 16.²
• Nails: Zasocitinib also delivered statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo at week 16 (p<0.001).²
• Responses were sustained through week 24 in both studies.²
• The most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals identified.²

"Despite advances in psoriasis care, many patients continue to experience persistent symptoms, especially in highly visible or sensitive areas like the scalp — impacting about half of patients with psoriasis — which can disproportionately affect daily life," said Leon Kircik, MD, founder and medical director of Skin Sciences and Physicians Skin Care, Louisville, KY, principal investigator for the LATITUDE PsO studies and presenting author. "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."

Next steps for zasocitinib

Takeda plans to submit a New Drug Application for plaque psoriasis with the United States Food and Drug Administration and other regulatory authorities beginning this fiscal year. Zasocitinib is also being evaluated in Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS).^7-12

About Plaque Psoriasis

Psoriasis is a chronic, systemic immune-mediated inflammatory disease characterized by itchy, painful, disfiguring and disabling skin lesions that impact one’s physical, emotional and psychological wellbeing.^3,13-18 Globally, an estimated 64 million people are living with psoriasis, and about 80-90% of those have plaque psoriasis.^19-20 Persistent itch, the appearance and location of skin lesions — especially in highly visible or sensitive areas — and related comorbidities, like psoriatic arthritis, play a major role in reducing quality of life and can lead to significant impacts on daily living.^3,16-18 Psoriasis is also a heterogeneous disease driven by complex, interconnected immune pathways, genetics and environmental factors that differ across patients and over time, leading to variability in disease course, symptoms and treatment response.^21-25

About Zasocitinib (TAK-279)

Zasocitinib is an investigational, next-generation, highly selective and potent oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways.^26-30 It has the potential to be a leading oral treatment option for people living with psoriasis that may deliver rapid and durable skin clearance in a convenient once-daily pill.⁶ Zasocitinib has more than 1-million-fold greater selectivity for TYK2 compared to other JAK enzymes, which could maximize TYK2 inhibition without impacting JAK1, 2 and 3 signaling, based on in vitro data.^26-27 Takeda is currently evaluating the safety and efficacy of zasocitinib in Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS).^7-12 Zasocitinib is an investigational compound that has not been approved for use by any regulatory authority.

About the LATITUDE Psoriasis Phase 3 Studies

The LATITUDE Phase 3 psoriasis studies (NCT06088043 and NCT06108544) are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies to evaluate the efficacy, safety and tolerability of zasocitinib in adult patients with moderate-to-severe plaque psoriasis.^31-32 The studies were conducted in 21 countries and enrolled 693 and 1,108 participants, respectively. The co-primary endpoints were the proportion of zasocitinib-treated patients achieving sPGA 0/1 and PASI 75 response compared to placebo at week 16. ^31-32 Ranked (key) secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24). ^31-32

Secondary endpoints that evaluated high-impact sites included:

• Scalp (assessed in 38% and 28% of overall study population):² Proportion of patients achieving scalp-specific PGA (ssPGA) response (defined as clear [0] or almost clear [1] with ≥2-point decrease from baseline [in patients with baseline ssPGA ≥3, baseline psoriasis scalp severity index ≥12 and scalp surface area involvement ≥30%]) at week 16 (versus placebo and/or apremilast) and week 24 (versus apremilast);^31-32
• Palms and soles (palmoplantar; assessed in 24% and 22% of the overall study population):² Proportion of patients with PGA of the palmoplantar hands and/or feet (hfPGA) response (defined as clear [0] or almost clear [1] with ≥2-point decrease from baseline [in patients with baseline hfPGA ≥3]) at week 16 (versus placebo and/or apremilast) and week 24 (versus apremilast);^31-32
• Nails (assessed in 37% and 30% of the overall study population):² Change from baseline (CfB) in Nail Psoriasis Severity Index (NAPSI) (in patients with nail involvement at baseline) at week 16 (versus placebo).^31-32

About Tyrosine Kinase 2 (TYK2) Inhibitors

TYK2 is a central mediator of core inflammatory pathways in psoriasis — IL-23/IL-17 axis and type I interferon signaling — making it a promising target as inhibition of a single pathway may not fully control disease for every patient.^25,29,33 TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.^25-26 However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes such as lipid metabolism and hematopoiesis, which can be linked to cardiovascular risks and blood disorders when disrupted.^25-26,34 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, is a promising therapeutic approach to target immune-mediated inflammation while potentially avoiding risks associated with inhibition of other members of the JAK family.³⁰

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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References

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