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A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
Sponsor: Takeda
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.
Official title: 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
Key Details
Gender
All
Age Range
4 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2025-12-04
Completion Date
2033-01-24
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Zasocitinib
Zasocitinib.
Placebo
Zasocitinib matching placebo.
Zasocitinib
Zasocitinib.
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
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Beijing Children Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Hunan Children's Hospital
Changsha, Hunan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Peking University Third Hospital
Beijing, China
Huashan Hospital Fudan University
Shanghai, China
Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Hesse, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany
Uniklinik Koln, Klinik fur Dermatologie und Venerologie
Cologne, North Rhine-Westphalia, Germany
University Hospital of Muenster
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, Germany
Presidio Ospedaliero Gaspare Rodolico
Catania, Sicily, Italy
Universita Degli Studi Di Padova
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Fukuoka, Japan
Mie University Hospital
Tsu, Mie, Mie-ken, Japan
Nippon Life Hospital
Osaka, Osaka, Japan
Teikyo University Hospital
Itabashi-Ku, Tokyo, Japan
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
Wroclaw, Lower Silesian Voivodeship, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
Lublin, Lublin Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, Poland
Centrum Badan Klinicznych Pi-house Sp. Z O. O.
Gdansk, Pomeranian Voivodeship, Poland
"DERMED" Centrum Medyczne Sp. z o. o.
Lodz, Poland
Dermoklinika-Centrum Medyczne s.c
Lodz, Poland
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital de La Santa Creu i Sant Pau - Dermatologia
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain