Recruiting
Phase 3

Zasocitinib

Sponsor:

Takeda

Code:

NCT07250802

Conditions

Plaque Psoriasis

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Zasocitinib

Placebo

Zasocitinib

Study Details

Brief 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.

Conditions

Plaque Psoriasis

Study ID

NCT07250802

Start date

Dec 4, 2025

Status verified date

Jul, 2026

Completion date

Jan 24, 2033

Anticipated

Primary completion date

Jan 24, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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.
6. Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (<) 18 years, inclusive.
7. Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to <12 years, inclusive.
8. Inclusion Criteria for Part A Cohort 1: The participant must weigh >=40 kilograms (kg) at the time of screening.

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.

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A (Cohort 1): Zasocitinib (Dose A)

Participants (Adolescent) aged 12 to less than (<)18 years will receive zasocitinib Dose A once daily (QD), orally, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib, from Week 16 to Week 208 during the open-label period.

experimental: Part A (Cohort 2): Zasocitinib (Multiple Doses)

Participants (Children) aged 4 to <12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib from Week 16 to Week 208 during the open-label period.

placebo comparator: Part A (Cohort 1 and Cohort 2): Placebo

Participants in Cohort 1 (Adolescent aged 12 to <18 years) and Cohort 2 (Children aged 4 to <12 years) will receive zasocitinib matching placebo QD from Week 1 to Week 16 during the double-blind placebo-controlled period.

experimental: Part B: Zasocitinib (Multiple Doses)

Participants (Children) aged 4 to <12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 208 during the open-label period.

Interventions

Zasocitinib

Zasocitinib.

Placebo

Zasocitinib matching placebo.

Zasocitinib

Zasocitinib.

Primary outcome measure

  • Part A: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater than or Equal to (>=) 2-Point Decrease From Baseline at Week 16 [ Time Frame: At Week 16 ]
  • Part A: Percentage of Participants Achieving >= 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 [ Time Frame: At Week 16 ]
  • Part B: Maximum Observed Plasma Concentration (Cmax) of Zasocitinib [ Time Frame: Pre-dose and Post-dose on Day 7 ]
  • Part B: Time to Maximum Concentration (Tmax) of Zasocitinib [ Time Frame: Pre-dose and Post-dose on Day 7 ]
  • Part B: Area Under the Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-Last) of Zasocitinib [ Time Frame: Pre-dose and Post-dose on Day 7 ]

Central Contacts and Locations

Central contacts

Locations

Exalt Clinical Research

Recruiting

Chula Vista, California, United States, 91910

Contacts

Principal Investigator:

Jaqueline McKesey

First OC Dermatology Research Inc.

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Principal Investigator:

Vivian Laquer

Direct Helpers Medical Center

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Principal Investigator:

Frank Don

Arlington Dermatology

Recruiting

Rolling Meadows, Illinois, United States, 60008-3811

Contacts

Principal Investigator:

Michael Bukhalo

Apex Clinical Research Center, LLC

Recruiting

Canton, Ohio, United States, 44718

Contacts

Principal Investigator:

Jorge Garcia-Zuazaga

Wright State Physicians

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Principal Investigator:

Craig Rohan

Apex Clinical Research Center, LLC

Recruiting

Mayfield Heights, Ohio, United States, 44124-4005

Contacts

Principal Investigator:

Jorge Garcia-Zuazaga

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Lara Wine Lee

Texas Dermatology and Laser Specialists-San Antonio

Recruiting

San Antonio, Texas, United States, 78218-3128

Contacts

Principal Investigator:

John Browning

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site contact

kholland@mcw.edu

Principal Investigator:

Kristen Holland

More Information

Sponsor

Takeda

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Drug Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Takeda on 2026-07-21.