Zasocitinib for Plaque Psoriasis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
This study is for children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis. They must have been diagnosed at least 6 months prior, have stable psoriasis without significant changes recently, and need phototherapy or systemic therapy. Teens must weigh at least 40 kg.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Zasocitinib
Trial Overview
The trial tests Zasocitinib's effectiveness and safety in young patients with plaque psoriasis over up to four years. Initially, teens may receive the drug or a placebo for 16 weeks; afterwards, all participants get Zasocitinib. Younger kids start directly on the drug.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
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