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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Tyk2 inhibitor
DrugSpecific dose of Tyk2 inhibitor on specific days
Placebo
DrugSpecified dose of Placebo on specified days.
Treatment groups
Trial outcomes
Primary outcomes
The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12
Secondary outcomes
Percentage of Participants With PASI-90, PASI-100 on Week 12
Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate)
Change From Baseline in DLQI Scores to Week 12
Change From Baseline in BSA to Week 12
Sponsors and contacts
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