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New pill could clear skin in kids with psoriasis – trial underway

NCT ID NCT07250802

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether zasocitinib, an oral medication, can safely and effectively treat moderate-to-severe plaque psoriasis in children and teens aged 4 to 17. The study involves 110 participants and lasts up to 4 years. In the first part, some receive the drug and others a placebo for 16 weeks; after that, everyone gets the drug. The goal is to see if the drug can clear or nearly clear the skin and reduce psoriasis severity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zasocitinib (a pill that targets inflammation)
What this could lead to
If it works, this could provide a new treatment option for children and teens with moderate-to-severe plaque psoriasis, potentially clearing or nearly clearing their skin.
What could go wrong
This is still a clinical trial, so it's not yet proven to work in children. Possible side effects include infections or other inflammatory-related issues. The study is relatively small (110 participants), so results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plaque psoriasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    39 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • "DERMED" Centrum Medyczne Sp. z o. o.

    RECRUITING

    Lodz, 90-265, Poland

  • Apex Clinical Research Center, LLC

    RECRUITING

    Canton, Ohio, 44718, United States

  • Apex Clinical Research Center, LLC

    RECRUITING

    Mayfield Heights, Ohio, 44124-4005, United States

  • Arlington Dermatology

    RECRUITING

    Rolling Meadows, Illinois, 60008-3811, United States

  • Beijing Children Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100045, China

  • Centrum Badan Klinicznych Pi-house Sp. Z O. O.

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

  • Complejo Hospitalario Universitario de Santiago de Compostela

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

  • Dermatology Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510091, China

  • Dermoklinika-Centrum Medyczne s.c

    RECRUITING

    Lodz, 90-436, Poland

  • Direct Helpers Medical Center

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Exalt Clinical Research

    RECRUITING

    Chula Vista, California, 91910, United States

  • Fachklinik Bad Bentheim

    RECRUITING

    Bad Bentheim, Lower Saxony, 48455, Germany

  • First OC Dermatology Research Inc.

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

  • Hangzhou First People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital de La Santa Creu i Sant Pau - Dermatologia

    RECRUITING

    Barcelona, 08041, Spain

  • Hospital of the University of Occupational and Environmental Health, Japan

    RECRUITING

    Kitakyushu-shi, Fukuoka, 807-8555, Japan

  • Huashan Hospital Fudan University

    RECRUITING

    Shanghai, 200040, China

  • Hunan Children's Hospital

    RECRUITING

    Changsha, Hunan, 410007, China

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska

    RECRUITING

    Lublin, Lublin Voivodeship, 20-573, Poland

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mie University Hospital

    RECRUITING

    Tsu, Mie, Mie-ken, 514-8507, Japan

  • Nagoya City University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • Nippon Life Hospital

    RECRUITING

    Osaka, Osaka, 550-0006, Japan

  • Peking University Third Hospital

    RECRUITING

    Beijing, 100191, China

  • Presidio Ospedaliero Gaspare Rodolico

    RECRUITING

    Catania, Sicily, 95123, Italy

  • Teikyo University Hospital

    RECRUITING

    Itabashi-Ku, Tokyo, 173-0003, Japan

  • Texas Dermatology and Laser Specialists-San Antonio

    RECRUITING

    San Antonio, Texas, 78218-3128, United States

  • UT Physicians Dermatology - Bellaire Station

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Uniklinik Koln, Klinik fur Dermatologie und Venerologie

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universita Degli Studi Di Padova

    NOT_YET_RECRUITING

    Padova, 35121, Italy

  • Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

  • University Hospital of Muenster

    RECRUITING

    Münster, North Rhine-Westphalia, 48145, Germany

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

    RECRUITING

    Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

  • Wright State Physicians

    RECRUITING

    Fairborn, Ohio, 45324, United States

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