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

NCT07752108 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: TAK-279-PsO-3007
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Palmoplantar Psoriasis

Keywords

Drug Therapy; Psoriasis; Plaque Psoriasis; Moderate to Severe Plaque Psoriasis; Plaque Psoriasis with Palmoplantar (Non-Pustular)

Outcome Measures

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."

  At Week 16

Secondary Outcomes (31)

• 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

  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

  At Week 16

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

  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

  At Week 16

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

  At Week 16

Study Arms (3)

Part 1: Zasocitinib 30 mg

EXPERIMENTAL

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.

Drug: Zasocitinib

Part 2: Zasocitinib 30 mg

EXPERIMENTAL

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.

Drug: Zasocitinib

Optional Long-Term Extension (LTE): Zasocitinib

EXPERIMENTAL

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.

Drug: Zasocitinib

Interventions

Zasocitinib DRUG

Zasocitinib oral tablet.

Also known as: TAK-279, NDI-034858

Optional Long-Term Extension (LTE): Zasocitinib; Part 1: Zasocitinib 30 mg; Part 2: Zasocitinib 30 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Related Links

• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): February 15, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.