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
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.
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