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NCT07250802PHASE3Recruiting

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

Takeda

Start Date

12/4/2025

Completion Date

1/24/2033

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 Criteria

Age Range: 4 years to 17 years

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.

Interventions

DRUG

Zasocitinib

DRUG

Placebo

DRUG

Zasocitinib

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Conditions

Plaque Psoriasis

Locations

Exalt Clinical Research

Chula Vista, California 91910

United States

First OC Dermatology Research Inc.

Fountain Valley, California 92708

United States

Direct Helpers Medical Center

Hialeah, Florida 33012

United States

Arlington Dermatology

Rolling Meadows, Illinois 60008-3811

United States

Apex Clinical Research Center, LLC

Canton, Ohio 44718

United States

Wright State Physicians

Fairborn, Ohio 45324

United States

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio 44124-4005

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

UT Physicians Dermatology - Bellaire Station

Bellaire, Texas 77401

United States

Texas Dermatology and Laser Specialists-San Antonio

San Antonio, Texas 78218-3128

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Beijing Children Hospital, Capital Medical University

Beijing, Beijing Municipality 100045

China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong 510091

China

Hunan Children's Hospital

Changsha, Hunan 410007

China

Hangzhou First People's Hospital

Hangzhou, Zhejiang 310006

China

Peking University Third Hospital

Beijing, 100191

China

Huashan Hospital Fudan University

Shanghai, 200040

China

Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt am Main, Hesse 60596

Germany

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony 48455

Germany

Uniklinik Koln, Klinik fur Dermatologie und Venerologie

Cologne, North Rhine-Westphalia 50937

Germany

University Hospital of Muenster

Münster, North Rhine-Westphalia 48145

Germany

Universitätsklinikum Bonn

Bonn, 53127

Germany

Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

Mainz, 55131

Germany

Presidio Ospedaliero Gaspare Rodolico

Catania, Sicily 95123

Italy

Universita Degli Studi Di Padova

Padova, 35121

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168

Italy

Nagoya City University Hospital

Nagoya, Aichi-ken 467-8602

Japan

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-shi, Fukuoka 807-8555

Japan

Mie University Hospital

Tsu, Mie, Mie-ken 514-8507

Japan

Nippon Life Hospital

Osaka, Osaka 550-0006

Japan

Teikyo University Hospital

Itabashi-Ku, Tokyo 173-0003

Japan

Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p

Wroclaw, Lower Silesian Voivodeship 50-566

Poland

Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska

Lublin, Lublin Voivodeship 20-573

Poland

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, Podkarpackie Voivodeship 35-055

Poland

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

Gdansk, Pomeranian Voivodeship 80-546

Poland

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

Lodz, 90-265

Poland

Dermoklinika-Centrum Medyczne s.c

Lodz, 90-436

Poland

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna 15706

Spain

Hospital de La Santa Creu i Sant Pau - Dermatologia

Barcelona, 08041

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain