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
Qualifiers
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
Treatments tested in this trial
- Zasocitinib
Treatment groups
40 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov