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A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

NCT07250802•Takeda

View on ClinicalTrials.gov

Summary

The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children. At first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib. Participants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study. Participants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.

Eligibility

Age

4 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (\>=) 6 months prior to the screening visit.
•2. Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for \>=6 months before screening.
•3. Participant has moderate-to-severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score \>=12 and a Static Physician's Global Assessment (sPGA) score \>=3 at screening and Day 1.
•4. Participant has plaque psoriasis covering \>=10 percent (%) of total body surface area (BSA) at screening and Day 1.
•5. Participant must be a candidate for phototherapy or systemic therapy.

Exclusion Criteria

•1. Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
•2. Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease.
•3. Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
•4. Participant has history of active TB infection, regardless of treatment status and has signs or symptoms of active TB or evidence of latent tuberculosis infection (LTBI).
•5. Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 or a history of serious herpetic infection.
•6. Participant has a history of chronic or recurrent bacterial disease.
•7. Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
•8. Participant has any clinically significant medical condition, evidence of an unstable clinical condition or vital signs/physical examination/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results.
•9. Participant has any previous exposure to zasocitinib (also known as TAK-279 or NDI-034858) or other TYK2 inhibitors or participated in any trial that included a tyrosine kinase 2 (TYK2) inhibitor, unless participant has documentation of posttrial unblinding that confirms the participant did not receive a TYK2 inhibitor.
•10. Participant is not up to date on all required vaccinations according to current immunization guidelines as noted by country-specific pediatric authorities.

Locations (40)

Exalt Clinical Research

Chula Vista, California, United States

First OC Dermatology Research Inc.

Fountain Valley, California, United States

Direct Helpers Medical Center

Hialeah, Florida, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Apex Clinical Research Center, LLC

Canton, Ohio, United States

Wright State Physicians

Fairborn, Ohio, United States

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

UT Physicians Dermatology - Bellaire Station

Bellaire, Texas, United States

Texas Dermatology and Laser Specialists-San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

December 4, 2025

Primary Completion Date

January 24, 2033

Completion Date

January 24, 2033

Last Updated

March 9, 2026

Enrollment

110

ESTIMATED participants

Conditions

Plaque Psoriasis

Interventions

Zasocitinib

DRUG

Placebo

DRUG

Zasocitinib

DRUG

Contacts

Takeda Contact

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

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A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

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