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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Tyk2 inhibitor

Specific dose of Tyk2 inhibitor on specific days

DRUG

Placebo

Specified dose of Placebo on specified days.

Locations (1)

Shanghai Skin Disease Hospital
Shanghai, China