Recruiting NCT07234591
A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tyk2 inhibitor, Placebo.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis, Moderate to Severe Plaque Psoriasis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks
Interventions
- Drug Tyk2 inhibitor
Specific dose of Tyk2 inhibitor on specific days - Drug Placebo
Specified dose of Placebo on specified days.
Primary outcome measures
- The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12 [Time frame: Baseline to Week 12]
Secondary outcome measures (8)
- Percentage of Participants With PASI-90, PASI-100 on Week 12 [Time frame: Baseline to Week 12]
- Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate) [Time frame: Baseline to Week 12]
- Change From Baseline in DLQI Scores to Week 12 [Time frame: Baseline to Week 12]
- Change From Baseline in BSA to Week 12 [Time frame: Baseline to Week 12]
- Number of Participants With Adverse Events [Time frame: From enrollment to Day 112]
- Mean steady-state plasma concentration of the drug (Cav,ss) [Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84]
- Steady-state trough plasma concentration of the drug (Ctrough, ss) [Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84]
- The area under the steady-state blood drug concentration-time curve (AUCss) [Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Skin Disease Hospital — Shanghai
Identifiers
NCT: NCT07234591 · CN101