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

Conditions

• Palmoplantar Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zasocitinib — DRUG
  Zasocitinib oral tablet.

Study Details

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.

Key Dates

First listed

Aug 7, 2026

Start date

Sep 1, 2026

Status verified

Aug 2026

Primary completion

May 30, 2027

Completion

Feb 15, 2029

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Zasocitinib 30 mg
  Participants will receive zasocitinib 30 milligrams (mg), orally, once daily (QD) from Day 1 through Week 16. Participants who complete 16 weeks treatment will be eligible to continue into Part 2 and those who do not enter Part 2, will enter a 4-week safety follow-up period.
• Experimental: Part 2: Zasocitinib 30 mg
  Eligible participants who continue from Part 1 to Part 2 (if determined by principal investigator \[PI\]) will receive zasocitinib 30 mg, orally, QD from Week 16 through Week 52, followed by a 4-week safety follow-up period.
• Experimental: Optional Long-Term Extension (LTE): Zasocitinib
  Participants who are receiving zasocitinib and complete Week 52, will have the option to continue to receive uninterrupted zasocitinib therapy for up to an additional 52 weeks or until it becomes commercially available, whichever comes first.

Primary Outcome Measure

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 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]