RecruitingNot ApplicableNCT07234591

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

Sponsor

Usynova Pharmaceuticals Ltd.

Enrollment

140 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Plaque Psoriasis Moderate to Severe Plaque Psoriasis

Summary

A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

Male and female, ages 18 to 70 years
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 Criteria7

Diagnosed with non-plaque psoriasis
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.

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