Ireland
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Recruiting Not applicable

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

NCT07234591 · tracked via the Priya Life Science China tracker
Sponsor
Usynova Pharmaceuticals Ltd
Phase
Not applicable
Started
2025-10-21
Last updated
2025-11-18

Condition(s) studied

Plaque PsoriasisModerate to Severe Plaque Psoriasis

Investigational drug(s) / intervention(s)

Tyk2 inhibitorPlacebo

Tyk2 inhibitor: Specific dose of Tyk2 inhibitor on specific days

Placebo: Specified dose of Placebo on specified days.

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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. Other protocol defined inclusion/exclusion criteria could apply

Primary outcome measure(s)

  • The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12 — Baseline to Week 12

Trial sites (1)

FacilityCityRegionStatus
Shanghai Skin Disease Hospital Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07234591 on ClinicalTrials.gov ↗ ← All trials in China