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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Zasocitinib oral tablet.
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
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."
Time frame: At Week 16
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
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.
Time frame: At Week 16
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
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.
Time frame: At Week 16
Part 1: Percentage of Participants Achieving an sPGA 0 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.
Time frame: At Week 16
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
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.
Time frame: At Week 16
Part 1: Percentage of Participants who Achieve a Score of 0 or 1 in Itch NRS 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.
Time frame: At Week 16
Part 2: Percentage of Participants Achieving PPASI-75, PPASI-90 and PPASI-100 From Baseline 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.
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants Achieving PPASI-75, PPASI-90 and PPASI-100 From Week 16 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).
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants Achieving sPGA 0 or 1 ("Clear" or "Almost Clear") From Baseline 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.
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants Achieving sPGA 0 or 1 ("Clear" or "Almost Clear") From Week 16 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.
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants Achieving sPGA of 0 From Baseline 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.
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants Achieving sPGA of 0 From Week 16 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.
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants Achieving ppIGA 0 From Baseline 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."
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants Achieving ppIGA 0 From Week 16 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."
Time frame: Week 16 up to Week 52
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
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'.
Time frame: Baseline up to Week 52
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
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'.
Time frame: Week 16 up to Week 52
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
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'.
Time frame: Baseline up to Week 52
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
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'.
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants who Achieve an Itch NRS of 0 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.
Time frame: At Week 52
Part 2: Change in Itch NRS From Baseline 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.
Time frame: Baseline up to Week 52
Part 2: Change in Itch NRS From Week 16 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.
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants With a Change in the Psoriasis Symptom Scale (PSS) From Baseline 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.
Time frame: Baseline up to Week 52
Part 2: Percentage of Participants With a Change in the PSS From Week 16 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.
Time frame: Week 16 up to Week 52
Part 2: Change in Palmoplantar Quality of Life Instrument (PPQLI) From Baseline 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.
Time frame: Baseline up to Week 52
Part 2: Change in PPQLI From Week 16 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.
Time frame: Week 16 up to Week 52
Part 2: Change in Dermatology Life Quality Index (DLQI) From Baseline 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).
Time frame: Baseline up to Week 52
Part 2: Change in DLQI From Week 16 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).
Time frame: Week 16 up to Week 52
Part 2: Percentage of Participants Achieving a DLQI Score of 0 or 1 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).
Time frame: At Week 52
Parts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs) and Serious Adverse Events (SAEs)
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.
Time frame: From screening up to follow up (up to 108 weeks)
Parts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Signs Values
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.
Time frame: From screening up to follow up (up to 108 weeks)
Parts 1 and 2: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values
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.
Time frame: From Baseline up to follow up (up to 108 weeks)
Parts 1 and 2: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Values
12-lead ECG will be evaluated. Any clinically significant changes from baseline in ECG values will be determined at the investigator's discretion.
Time frame: From Baseline up to follow up (up to 108 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.