Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07250802
PHASE3

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

Sponsor: 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.

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

Interventions

DRUG

Zasocitinib

Zasocitinib.

DRUG

Placebo

Zasocitinib matching placebo.

DRUG

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