Actively Recruiting
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a TYK2 Inhibitor in Adults With Moderate to Severe Plaque Psoriasis
Led by Usynova Pharmaceuticals Ltd. · Updated on 2025-11-18
140
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a TYK2 inhibitor in adults with moderate to severe plaque psoriasis. This study aims to understand how well this drug works to improve symptoms over a 12-week treatment period. Participants will be adults between 18 and 70 years old who have had plaque psoriasis for at least six months. Participants will be randomly assigned to receive one of three different doses of the TYK2 inhibitor or a placebo. The treatment is given according to specific dosing schedules over 12 weeks. This double-blind study means neither participants nor researchers know who is receiving the active drug or placebo during the trial. During the study, participants will have regular assessments to monitor their skin condition using the PASI score and other measures like sPGA, DLQI, and body surface area affected by psoriasis. Blood samples will be taken at multiple time points to measure drug levels, and safety will be tracked by recording any adverse events. The study lasts about 12 weeks, with follow-ups to evaluate treatment effects and safety.
CONDITIONS
Brief Title
A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 70 years
- Body weight greater than 40 kg and body mass index (BMI) between 18 and 40 kg/m2
- Clinical diagnosis of plaque psoriasis for at least 6 months before the baseline visit
- Women of childbearing potential and sexually active males must agree to use contraception methods
You will not qualify if you...
- Diagnosis of non-plaque psoriasis
- Previous treatment with tyrosine kinase 2 (TYK2) inhibitors
- Recent use of biological agents, immunoregulators, or hormonal drugs for psoriasis that may affect immunity
- Participation in any clinical trials within 30 days or 5 half-lives of a drug prior to first administration
- History of chronic diseases or severe infectious diseases that could affect the study, including active or untreated latent tuberculosis and severe bone or joint infections within 6 months before screening
- Known or suspected skin or systemic autoimmune diseases other than psoriasis and psoriatic arthritis
- Other conditions deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive specific doses of a TYK2 inhibitor or placebo to evaluate effectiveness and safety in treating moderate to severe plaque psoriasis.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Shanghai Skin Disease Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Yang Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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