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NCT Number: NCT07752108

A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis

Palmoplantar psoriasis (PPPsO) is a type of psoriasis that affects the palms of hands and soles of the feet. It can cause red, thick, scaly patches, and it is often associated with pain and itching. These symptoms can make daily life hard and can have a bigger effect on quality of life than psoriasis in some other areas of the body.

Treatment can also be difficult because the skin on the palms and soles is thick, so treatments put on the skin (topical treatments) may not work as well.

The main aim of this study is to find out how well zasocitinib works in reducing the skin redness, thickening, scaling, as well as fissures (narrow, elongated tears) on palms and soles of adults. Other aims are to learn if zasocitinib reduces the surface area of psoriasis on the palms and soles in adults with mainly Palmoplantar psoriasis.

The study is conducted in 2 parts with a possibility of continued treatment (long-term extension). In Part 1, participants will receive zasocitinib for 4 months (16 weeks). Participants who finish Part 1 may be able to continue to Part 2 if the study doctor thinks they would benefit. Participants who continue to Part 2, will keep taking zasocitinib until they have been treated for about 1 year (52 weeks). After that, participants may choose to keep taking zasocitinib for another year (52 weeks). Participants will be followed for about 1 month (4 weeks) after the end of treatment.

During the study, participants will visit their study clinic 16 times.

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Key information

Conditions

Palmoplantar Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant Willingness:

  • The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
  • The participant has provided informed consent and any required privacy authorization before the initiation of any trial procedures.

Disease Characteristics:

  • The participant has a diagnosis of chronic non-pustular palmoplantar psoriasis for greater than or equal to (>=) 6 months prior to the screening visit.
  • Participant has moderate-to-severe palmoplantar psoriasis, as defined by a ppIGA score >=3 at screening and Day 1 (Baseline).
  • At screening and Day 1 (Baseline), the participant meets all of the following criteria:
  • Moderate-to-severe plaque psoriasis as defined by an sPGA >=3
  • Moderate-to-severe palmoplantar psoriasis, as defined by a PPASI >=8
  • Plaque psoriasis BSA involvement of >=0.25 percent (%) and up to 10%, excluding the palms and soles
  • Participant must be a candidate for phototherapy or systemic therapy.
  • Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.

Age and Reproductive Status:

  • Participant is aged 18 years or older at the time of consent.
  • Participant meets the following birth control requirement: An individual with potential for pregnancy who is now surgically sterile; or a participant of nonchildbearing potential with laboratory confirmation of postmenopausal status; or, if sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who agrees to use a highly effective method of contraception from the time of signing of the informed consent throughout the duration of the trial and for at least 10 days after the last study dose of trial intervention. The use of effective contraception will be required for assigned male sex at birth participants.

Exclusion criteria

Target Disease-Related Exclusions:

  • Participant has evidence of nonplaque PsO (pustular PsO, palmoplantar pustulosis, acrodermatitis continua of Hallopeau, erythrodermic, or guttate PsO) or presence of pustules.
  • Participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.

Prohibited Psoriasis Treatments Exclusions:

For the below prohibited psoriasis treatments, the washout period prior to Day 1 must be within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition:

Participant has received any of the following biologics or biosimilar versions within the time frame indicated:

  • Antibodies to interleukin (IL)-12/23.
  • Antibodies to IL-23. There will be an allowance for up to 10 percent (%) of participants with previous IL-23 exposure to enroll. A washout period of 6 months prior to day 1 is required.
  • Previous exposure to Janus Kinase (JAK) inhibitors.
  • Previous exposure to Tyrosine Kinase 2 (TYK2) inhibitors.

Recent/Concurrent Infections Disease Exclusions:

  • History of active tuberculosis (TB), signs or symptoms of active TB. Evidence of latent TB infection, active Herpes infection at screening, history of serious herpetic infection or recurrent herpes zoster, evidence of Hepatitis C virus (HCV), evidence of Hepatitis B Virus (HBV) or HIV-positive status.

Noninfectious Disorders Exclusions:

  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to:
  • Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
  • Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts.
  • Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1

Allergies and Adverse Drug Reactions Exclusions:

  • Participant has history of significant drug allergy (such as anaphylaxis).
  • Participant has a known or suspected allergy to zasocitinib or any of their components.

Treatment and study plan

Zasocitinib

Drug

Zasocitinib oral tablet.

Other names: TAK-279, NDI-034858

Primary outcomes

  1. Part 1: Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) 0 or 1 ("Clear" or "Almost Clear") With at least a 2-point Reduction From Baseline at Week 16

    Time frame: At Week 16

    The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), scaling and fissures of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."

Secondary outcomes

  1. Part 1: Percentage of Participants Achieving >=75%, >=90% and 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI-75, PPASI-90 and PPASI-100) at Week 16

    Time frame: At Week 16

    The PPASI is an assessment tool based on the Psoriasis Area and Severity Index (PASI) that assesses induration (thickness), desquamation (scaling), erythema (redness) and surface area affected. Each symptom is evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for both palms and soles, gives a PPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). Higher score indicates more severe disease. PPASI-75, 90 and 100 are defined as participants achieving >= 75%, >=90% and 100% improvement from baseline.

  2. Part 1: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) 0 or 1 ("Clear" or "Almost Clear") With at Least a 2-point Reduction From Baseline at Week 16

    Time frame: At Week 16

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.

  3. Part 1: Percentage of Participants Achieving an sPGA 0 at Week 16

    Time frame: At Week 16

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.

  4. Part 1: Percentage of Participants With at Least a 3-point Reduction From Baseline in Skin Pain Numerical Rating Scale (NRS) at Week 16, Among Participants With a Baseline Skin Pain-NRS >=3

    Time frame: At Week 16

    The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'. Higher score indicates greater disease severity.

  5. Part 1: Percentage of Participants who Achieve a Score of 0 or 1 in Itch NRS at Week 16

    Time frame: At Week 16

    The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. Higher score indicates greater disease severity.

  6. Part 2: Percentage of Participants Achieving PPASI-75, PPASI-90 and PPASI-100 From Baseline to Week 52

    Time frame: Baseline up to Week 52

    The PPASI is an assessment tool based on the PASI that assesses induration (thickness), desquamation (scaling), erythema (redness) and surface area affected. Each symptom is evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for both palms and soles, gives a PPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). PPASI-75, 90 and 100 are defined as participants achieving >=75%, >=90% and 100% improvement from baseline.

  7. Part 2: Percentage of Participants Achieving PPASI-75, PPASI-90 and PPASI-100 From Week 16 to Week 52

    Time frame: Week 16 up to Week 52

    The PPASI is an assessment tool based on the Psoriasis Area and Severity Index (PASI) that assesses induration (thickness), desquamation (scaling), erythema (redness) and surface area affected. Each symptom is evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for both palms and soles, gives a PPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).

  8. Part 2: Percentage of Participants Achieving sPGA 0 or 1 ("Clear" or "Almost Clear") From Baseline to Week 52

    Time frame: Baseline up to Week 52

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.

  9. Part 2: Percentage of Participants Achieving sPGA 0 or 1 ("Clear" or "Almost Clear") From Week 16 to Week 52

    Time frame: Week 16 up to Week 52

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.

  10. Part 2: Percentage of Participants Achieving sPGA of 0 From Baseline to Week 52

    Time frame: Baseline up to Week 52

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.

  11. Part 2: Percentage of Participants Achieving sPGA of 0 From Week 16 to Week 52

    Time frame: Week 16 up to Week 52

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity.

  12. Part 2: Percentage of Participants Achieving ppIGA 0 From Baseline to Week 52

    Time frame: Baseline up to Week 52

    The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), scaling and fissures of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."

  13. Part 2: Percentage of Participants Achieving ppIGA 0 From Week 16 to Week 52

    Time frame: Week 16 up to Week 52

    The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), scaling and fissures of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."

  14. Part 2: Percentage of Participants With at Least a 3-point Reduction in Skin Pain-NRS From Baseline to Week 52, Among Participants With a Baseline Skin Pain-NRS >=3

    Time frame: Baseline up to Week 52

    The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'.

  15. Part 2: Percentage of Participants With at Least a 3-point Reduction in Skin Pain-NRS From Week 16 to Week 52, Among Participants With a Baseline Skin Pain-NRS >=3

    Time frame: Week 16 up to Week 52

    The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'.

  16. Part 2: Percentage of Participants With at Least a 4-point Reduction in Skin Pain-NRS From Baseline to Week 52, Among Participants With a Baseline Skin Pain-NRS >=4

    Time frame: Baseline up to Week 52

    The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'.

  17. Part 2: Percentage of Participants With at Least a 4-point Reduction in Skin Pain-NRS From Week 16 to Week 52, Among Participants With a Baseline Skin Pain-NRS >=4

    Time frame: Week 16 up to Week 52

    The Skin Pain NRS is a participant-reported measure that will capture the participant's reported skin pain on an NRS from 0-10. Participants rate worst skin pain within the past 24 hours, from 0 representing 'no pain' to 10 representing 'worse pain imaginable'.

  18. Part 2: Percentage of Participants who Achieve an Itch NRS of 0 at Week 52

    Time frame: At Week 52

    The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. Higher score indicates greater disease severity.

  19. Part 2: Change in Itch NRS From Baseline to Week 52

    Time frame: Baseline up to Week 52

    The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. Higher score indicates greater disease severity.

  20. Part 2: Change in Itch NRS From Week 16 to Week 52

    Time frame: Week 16 up to Week 52

    The Itch NRS is a single-item participant-reported measure. Participants indicate itch severity at its worst over a 24-hour recall period on an 11-point scale anchored at 0, representing 'no itching' and 10, representing 'worst itch imaginable'. Higher score indicates greater disease severity.

  21. Part 2: Percentage of Participants With a Change in the Psoriasis Symptom Scale (PSS) From Baseline to Week 52

    Time frame: Baseline up to Week 52

    The PSS is a participant-reported outcome instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are pain, redness, itching and stinging. Participants rate severity of each symptom using a 5-point scale ranging from 0 (none) to 4 (very severe). Higher score indicates greater disease severity.

  22. Part 2: Percentage of Participants With a Change in the PSS From Week 16 to Week 52

    Time frame: Week 16 up to Week 52

    The PSS is a participant-reported outcome instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are pain, redness, itching and stinging. Participants rate severity of each symptom using a 5-point scale ranging from 0 (none) to 4 (very severe). Higher score indicates greater disease severity.

  23. Part 2: Change in Palmoplantar Quality of Life Instrument (PPQLI) From Baseline to Week 52

    Time frame: Baseline up to Week 52

    The ppQLI assesses impact on participant quality of life due to palmoplantar psoriasis. Seventeen items evaluate hand functionality, disease symptoms (pain, burning and itch) and social impact due to psoriasis. Fifteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicates more severe disease.

  24. Part 2: Change in PPQLI From Week 16 to Week 52

    Time frame: Week 16 up to Week 52

    The ppQLI assesses impact on participant quality of life due to palmoplantar psoriasis. Seventeen items evaluate hand functionality, disease symptoms (pain, burning and itch) and social impact due to psoriasis. Fifteen items evaluate foot functionality, pain, and physical limitations due to psoriasis. All items use verbal rating scales ranging from 1 to 5. The ppQLI yields a score for hands, ranging from 16 to 80, and a score for feet, ranging from 14 to 70. Higher score indicates more severe disease.

  25. Part 2: Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 52

    Time frame: Baseline up to Week 52

    The DLQI is a 10-item validated questionnaire completed by participants which is used to assess the impact of skin disease on the participant's quality of life (QoL). The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).

  26. Part 2: Change in DLQI From Week 16 to Week 52

    Time frame: Week 16 up to Week 52

    The DLQI is a 10-item validated questionnaire completed by participants which is used to assess the impact of skin disease on the participant's quality of life (QoL). The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).

  27. Part 2: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 52

    Time frame: At Week 52

    The DLQI is a 10-item validated questionnaire completed by participants which is used to assess the impact of skin disease on the participant's quality of life (QoL). The questionnaire covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).

  28. Parts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs) and Serious Adverse Events (SAEs)

    Time frame: From screening up to follow up (up to 108 weeks)

    TEAE: Any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to trial intervention or medicinal product. SAE: Any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a suspected transmission of any infectious agent via an authorized medicinal product. An AESI (serious or nonserious) is one of scientific and medical concern specific to the compound or program and includes Infections that are severe or serious or opportunistic, for which ongoing monitoring and rapid communication by the investigator may be appropriate.

  29. Parts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Signs Values

    Time frame: From screening up to follow up (up to 108 weeks)

    Vital signs will include body temperature, sitting blood pressure (systolic and diastolic) and pulse. Any clinically significant changes in vital signs will be determined at the investigator's discretion.

  30. Parts 1 and 2: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values

    Time frame: From Baseline up to follow up (up to 108 weeks)

    Clinical laboratory parameters will include hematology, serum chemistry, and urinalysis. Any clinically significant changes from baseline in laboratory values will be determined at the investigator's discretion.

  31. Parts 1 and 2: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Values

    Time frame: From Baseline up to follow up (up to 108 weeks)

    12-lead ECG will be evaluated. Any clinically significant changes from baseline in ECG values will be determined at the investigator's discretion.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Moderate-to-severe Non-pustular Palmoplantar Psoriasis (PPPsO)

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Aug 7, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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