Takeda Reports New Phase 3 Data Showing Zasocitinib Delivers Strong Skin Clearance Across Difficult-to-Treat Areas in Plaque Psoriasis
Takeda has announced new findings from its two pivotal Phase 3 clinical studies evaluating zasocitinib (TAK-279), a next-generation oral tyrosine kinase 2 (TYK2) inhibitor being investigated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO). The latest results, presented during the 2026 American Academy of Dermatology (AAD) Innovation Academy, demonstrated that the investigational therapy produced high and consistent rates of skin clearance across several of the most challenging and high-impact areas affected by psoriasis, including the scalp, nails, palms, and soles of the feet.
The newly presented data represent secondary endpoint analyses from the global LATITUDE PsO 3001 and LATITUDE PsO 3002 Phase 3 clinical trials. These findings build upon previously announced topline results, which showed that approximately 70% of patients receiving zasocitinib achieved clear or almost clear skin after 16 weeks of treatment. Together, the data suggest that the once-daily oral therapy has the potential to provide rapid, durable, and comprehensive disease control for patients living with plaque psoriasis, including those whose disease affects body areas that are traditionally difficult to manage.
Advancing Oral Treatment Options for Plaque Psoriasis
Plaque psoriasis is a chronic immune-mediated inflammatory skin disease that affects millions of people worldwide. While advances in biologic therapies have transformed treatment over the past decade, many patients continue to seek convenient oral medications capable of delivering high levels of skin clearance comparable to injectable therapies.
Patients with psoriasis frequently experience lesions on visible or functionally important body regions such as the scalp, fingernails, palms of the hands, and soles of the feet. Disease in these locations can be particularly challenging because it often causes pain, itching, cracking, difficulty performing daily activities, and emotional distress. Conventional therapies may not always provide sufficient or durable improvement in these high-impact sites.
Takeda’s investigational therapy, zasocitinib, was developed to address these unmet needs by selectively targeting TYK2, an intracellular enzyme involved in regulating several inflammatory pathways known to drive psoriasis.
Targeting TYK2 to Interrupt Disease Activity
TYK2 plays a central role in transmitting inflammatory signals associated with several immune cytokines, including the IL-23/IL-17 pathway and type I interferons. These pathways are widely recognized as key contributors to the development and persistence of psoriasis.
Unlike broader Janus kinase (JAK) inhibitors, zasocitinib has been designed as a highly selective TYK2 inhibitor, allowing it to specifically suppress disease-driving immune activity while minimizing effects on other signaling pathways.
This selectivity is intended to improve efficacy while maintaining a favorable safety profile, making the therapy a promising candidate for long-term management of chronic inflammatory diseases.
Takeda believes this mechanism positions zasocitinib as a next-generation oral therapy capable of delivering robust skin clearance with the convenience of once-daily dosing.
Strong Results Across Difficult-to-Treat Body Areas
The Phase 3 LATITUDE PsO 3001 and 3002 studies included patients with moderate-to-severe plaque psoriasis who also presented with involvement of difficult-to-treat body regions at the beginning of the trials.
Researchers evaluated treatment responses in patients experiencing:
- Scalp psoriasis
- Nail psoriasis
- Palmoplantar psoriasis affecting the hands and feet
Across both studies, zasocitinib consistently demonstrated superior efficacy compared with placebo and, in many analyses, also outperformed apremilast, an established oral treatment for psoriasis.
Significant Improvement in Scalp Psoriasis
Scalp psoriasis is among the most common manifestations of the disease, affecting nearly half of all individuals diagnosed with psoriasis. Because hair often limits the application of topical medications, scalp involvement can be especially difficult to treat.
Patients receiving zasocitinib achieved impressive rates of scalp clearance after 16 weeks of therapy.
In the two Phase 3 studies:
- 77% and 74% of patients treated with zasocitinib achieved a scalp-specific Physician Global Assessment (ssPGA) score of 0 or 1, indicating clear or almost clear skin.
- By comparison, only 7% and 13% of placebo-treated patients reached the same endpoint.
- Zasocitinib also substantially outperformed apremilast, where response rates were 42% and 30%.
These differences were statistically significant, demonstrating the therapy’s ability to provide meaningful improvements in one of psoriasis’ most challenging treatment locations.
Encouraging Outcomes in Palmoplantar Psoriasis
Psoriasis affecting the palms and soles often causes painful skin thickening, cracking, and impaired mobility. Even relatively small lesions in these areas can significantly affect quality of life by interfering with walking, grasping objects, and performing everyday tasks.
Approximately 70% of patients receiving zasocitinib achieved a hands and/or feet-specific Physician Global Assessment (hfPGA) score of 0 or 1 after 16 weeks.
Specifically:
- Response rates reached 71% and 69% in the two studies.
- Placebo groups achieved only 22% and 10%.
- Patients receiving apremilast achieved response rates of 44% and 43%.
Although some analyses were reported as numerical improvements, the overall findings demonstrated a strong therapeutic effect in this particularly difficult patient population.
Meaningful Improvement in Nail Psoriasis
Nail psoriasis is another notoriously difficult manifestation of the disease, often resulting in pitting, discoloration, thickening, nail separation, and discomfort.
Because nails grow slowly, improvements can require extended treatment periods, making successful therapy especially valuable.
The Phase 3 studies demonstrated statistically significant improvements in the Nail Psoriasis Severity Index (NAPSI) among patients treated with zasocitinib compared with placebo by Week 16.
The findings suggest that the investigational therapy effectively reduces inflammation affecting the nail unit while supporting healthier nail growth over time.
Durable Responses Through Six Months
In addition to rapid improvements, investigators observed sustained treatment benefits throughout the 24-week evaluation period.
Patients who responded during the first 16 weeks generally maintained or further improved their skin clearance through Week 24.
These longer-term results reinforce earlier findings from the LATITUDE studies showing that therapeutic responses continued to strengthen over time rather than diminishing after initial improvement.
Durable disease control remains an important objective in psoriasis management, particularly for chronic conditions requiring lifelong treatment.
Earlier Phase 3 Results Demonstrated Rapid Disease Control
The newly presented analyses build upon previously released topline findings from the LATITUDE PsO 3001 and 3002 studies.
Earlier results demonstrated that approximately 70% of patients receiving zasocitinib achieved a static Physician Global Assessment (sPGA) score of 0 or 1 after 16 weeks, indicating clear or almost clear skin.
In addition, patients experienced significant improvements in the Psoriasis Area and Severity Index (PASI 75) beginning as early as Week 4.
Responses continued to improve through Week 24, highlighting the therapy’s combination of rapid onset and sustained effectiveness.
Takeda Highlights Potential of Next-Generation TYK2 Inhibition
Commenting on the findings, Dr. Chinwe Ukomadu, Senior Vice President and Head of Takeda’s Gastrointestinal & Inflammation Therapeutic Area Unit, emphasized the complexity of psoriasis and the importance of targeting underlying immune pathways responsible for disease variability.
She noted that psoriasis presents differently among patients and often affects body regions that remain difficult to treat. According to Ukomadu, TYK2 plays an essential role in regulating several core inflammatory pathways involved in disease progression, including the IL-23/IL-17 axis and type I interferon signaling.
She stated that the Phase 3 results reinforce the potential of zasocitinib to provide rapid, durable, and consistent skin clearance through the convenience of a once-daily oral medication.
Investigator Highlights Benefits for Patients
Dr. Leon Kircik, founder and medical director of Skin Sciences and Physicians Skin Care in Louisville, Kentucky, served as a principal investigator in the LATITUDE PsO program and presented the latest findings at the AAD Innovation Academy.
According to Kircik, despite major advances in psoriasis treatment, many patients continue to struggle with persistent symptoms, especially in highly visible or functionally sensitive body areas such as the scalp.
He explained that these locations often have a disproportionate impact on patients’ quality of life because they are associated with physical discomfort, cosmetic concerns, and social challenges.
The consistent improvements observed across the scalp, nails, palms, and soles suggest that zasocitinib has the potential to become one of the leading oral treatment options for individuals seeking comprehensive, whole-body skin clearance.
Favorable Safety Profile Observed
Safety findings through the first 24 weeks of treatment remained consistent with earlier clinical observations.
The most commonly reported adverse events included:
- Upper respiratory tract infections
- Nasopharyngitis
- Acne
Importantly, investigators reported no new safety signals during the study period, supporting the continued clinical development of the investigational therapy.
Maintaining a favorable safety profile is especially important for chronic diseases like psoriasis, where patients often require long-term treatment extending over many years.
Regulatory Plans and Broader Development Program
Following the positive Phase 3 results, Takeda plans to begin submitting a New Drug Application (NDA) for zasocitinib to the U.S. Food and Drug Administration (FDA) and other global regulatory authorities during the current fiscal year.
Beyond plaque psoriasis, the company is evaluating the TYK2 inhibitor across multiple immune-mediated inflammatory diseases.
Current clinical development includes:
- Phase 3 studies in psoriatic arthritis
- Phase 2 studies in Crohn’s disease
- Ulcerative colitis
- Vitiligo
- Hidradenitis suppurativa (HS)
These ongoing programs reflect Takeda’s broader strategy of leveraging TYK2 inhibition across diseases driven by overlapping inflammatory pathways.
The latest Phase 3 findings further strengthen the clinical profile of zasocitinib as a promising next-generation oral therapy for moderate-to-severe plaque psoriasis. By demonstrating rapid, durable, and consistent skin clearance across some of the most difficult-to-treat body regions—including the scalp, nails, palms, and soles—the investigational TYK2 inhibitor addresses key unmet needs in psoriasis care.
Combined with encouraging safety results and the convenience of once-daily oral administration, zasocitinib has the potential to become an important new treatment option if approved. As Takeda prepares regulatory submissions and advances additional clinical trials in psoriasis and other immune-mediated diseases, the therapy could play a significant role in expanding treatment choices for patients seeking effective, long-term disease control.
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.25,29,33TYK2 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.