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
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 17
Healthy Volunteers: f
View:
• Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (\>=) 6 months prior to the screening visit.
• 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.
• 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.
• Participant has plaque psoriasis covering \>=10 percent (%) of total body surface area (BSA) at screening and Day 1.
• Participant must be a candidate for phototherapy or systemic therapy.
• Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (\<) 18 years, inclusive.
• Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to \<12 years, inclusive.
• Inclusion Criteria for Part A Cohort 1: The participant must weigh \>=40 kilograms (kg) at the time of screening.
Locations
United States
California
Exalt Clinical Research
RECRUITING
Chula Vista
First OC Dermatology Research Inc.
NOT_YET_RECRUITING
Fountain Valley
Florida
Direct Helpers Medical Center
RECRUITING
Hialeah
Illinois
Arlington Dermatology
RECRUITING
Rolling Meadows
Ohio
Apex Clinical Research Center, LLC
NOT_YET_RECRUITING
Canton
Wright State Physicians
RECRUITING
Fairborn
Apex Clinical Research Center, LLC
NOT_YET_RECRUITING
Mayfield Heights
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Texas
UT Physicians Dermatology - Bellaire Station
NOT_YET_RECRUITING
Bellaire
Texas Dermatology and Laser Specialists-San Antonio
NOT_YET_RECRUITING
San Antonio
Wisconsin
Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Other Locations
China
Beijing Children Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Hunan Children's Hospital
NOT_YET_RECRUITING
Changsha
Dermatology Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Hangzhou First People's Hospital
NOT_YET_RECRUITING
Hangzhou
Huashan Hospital Fudan University
NOT_YET_RECRUITING
Shanghai
Germany
Fachklinik Bad Bentheim
NOT_YET_RECRUITING
Bad Bentheim
Universitätsklinikum Bonn
NOT_YET_RECRUITING
Bonn
Uniklinik Koln, Klinik fur Dermatologie und Venerologie
NOT_YET_RECRUITING
Cologne
Johann Wolfgang Goethe-Universität Frankfurt am Main
NOT_YET_RECRUITING
Frankfurt Am Main
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Hospital de La Santa Creu i Sant Pau - Dermatologia
NOT_YET_RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Complejo Hospitalario Universitario de Santiago de Compostela
NOT_YET_RECRUITING
Santiago De Compostela
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date:2025-12-04
Estimated Completion Date:2033-01-24
Participants
Target number of participants:110
Treatments
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.