A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis
NCT ID: NCT07234591
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2025-10-21
2026-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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dose level 1
Tyk2 inhibitor
Specific dose of Tyk2 inhibitor on specific days
dose level 2
Tyk2 inhibitor
Specific dose of Tyk2 inhibitor on specific days
dose level 3
Tyk2 inhibitor
Specific dose of Tyk2 inhibitor on specific days
placebo
Placebo
Specified dose of Placebo on specified days.
Interventions
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Tyk2 inhibitor
Specific dose of Tyk2 inhibitor on specific days
Placebo
Specified dose of Placebo on specified days.
Eligibility Criteria
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Inclusion Criteria
* Body weight \>40 kg, body mass index (BMI) of 18 to 40 kg/m2
* Clinical diagnosis of plaque psoriasis for ≥6 months before the Baseline visit
* Women of childbearing potential (WOCBP) and males who are sexucally active must agree to follow instructions for method(s) of contraception.
Exclusion Criteria
* Previously received tyrosine kinase 2 (TYK2) inhibitors
* Previously received other psoriasis treatments such as biological agents, immunoregulators, or hormonal drugs within a specific period before administration, and the investigator deems it may affect the immunity of the subjects
* Has participated in any clinical trials within 30 days or 5 half-lives of the drug before the first administration, or currently undergoing visits for other clinical trials;
* Has history of chronic disease that may affect the study, or acute or chronic severe infectious diseases, such as a history of active or inadequately treated latent tuberculosis infection, severe bone or joint infections within 6 months before screening, and other acute infectious diseases.
* Has known or suspected skin or systemic autoimmune diseases other than psoriasis and psoriatic arthritis;
* Other conditions that the investigator deems unsuitable for participation in this study.
18 Years
70 Years
ALL
No
Sponsors
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Usynova Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Skin Disease Hospital
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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CN101
Identifier Type: -
Identifier Source: org_study_id
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