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

StatusRecruiting
PhasePhase 3
SponsorTakeda
Started2025-12-04
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 8 times since 2025-11-18; most recent filed 2026-07-20. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-07-20
Amendment Study Status, Contacts/Locations v8
2026-06-16
Amendment Study Status, Contacts/Locations v7
2026-05-07
Amendment Study Status, Contacts/Locations v6
2026-04-03
Amendment Study Status, Contacts/Locations v5
2026-03-06
Amendment Study Status, Contacts/Locations v4
2026-02-11
Amendment Study Status, Contacts/Locations, References v3
2026-01-15
Amendment Study Identification, Study Status, Contacts/Locations v2
2025-12-17
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations, References v1
2025-11-18
Original filing
Trial Details
NCT Number NCT07250802
Lead Sponsor Takeda
Conditions Plaque Psoriasis
Enrollment 110 participants
Start Date 2025-12-04
Primary Completion 2033-01-24 (estimated)
Study Completion 2033-01-24 (estimated)
Updated on ClinicalTrials.gov 2026-07-21