Moderate to Severe Plaque Psoriasis, Plaque Psoriasis
Conditions
Brief summary
A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks
Interventions
DRUGTyk2 inhibitor
Specific dose of Tyk2 inhibitor on specific days
DRUGPlacebo
Specified dose of Placebo on specified days.
Sponsors
Usynova Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate) | Baseline to Week 12 |
| Change From Baseline in DLQI Scores to Week 12 | Baseline to Week 12 |
| Change From Baseline in BSA to Week 12 | Baseline to Week 12 |
| Percentage of Participants With PASI-90, PASI-100 on Week 12 | Baseline to Week 12 |
| Mean steady-state plasma concentration of the drug (Cav,ss) | Day 1, Day 8, Day 15, Day 29, Day 57, Day 84 |
| Steady-state trough plasma concentration of the drug (Ctrough, ss) | Day 1, Day 8, Day 15, Day 29, Day 57, Day 84 |
| The area under the steady-state blood drug concentration-time curve (AUCss) | Day 1, Day 8, Day 15, Day 29, Day 57, Day 84 |
| Number of Participants With Adverse Events | From enrollment to Day 112 |
Countries
China
Contacts
Primary ContactYang Zhang
Outcome results
None listed