A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
ConditionPalmoplantar Psoriasis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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).
Disqualifiers
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Zasocitinib
DrugZasocitinib oral tablet.
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Part 1: Zasocitinib 30 mgExperimental treatment 1 intervention
Group B: Part 2: Zasocitinib 30 mgExperimental treatment 1 intervention
Group C: Optional Long-Term Extension (LTE): ZasocitinibExperimental treatment 1 intervention
Trial outcomes
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
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 16Secondary 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
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 162
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 163
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 164
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 16Locations
Source ClinicalTrials.gov
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