TYK2 inhibitor for adults 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

This will test whether a TYK2 inhibitor taken for 12 weeks helps adults with moderate to severe plaque psoriasis improve their skin and symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Usynova Pharmaceuticals Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07234591 on ClinicalTrials.gov

What this trial studies

This interventional trial compares a TYK2 inhibitor against placebo in adults with moderate to severe plaque psoriasis treated for 12 weeks. Eligible participants are adults aged 18–70 with at least six months of plaque psoriasis and specific weight and BMI requirements. Participants will receive either the TYK2 inhibitor or placebo and will be monitored for changes in skin disease severity and for side effects. The protocol excludes people with non-plaque psoriasis, prior TYK2 inhibitor use, recent systemic or biologic psoriasis treatments, or certain chronic or severe infections.

Who should consider this trial

Good fit: Adults 18–70 years old with a clinical diagnosis of plaque psoriasis for at least six months, weighing over 40 kg with BMI 18–40 kg/m2, and who agree to required contraception measures are the intended participants.

Not a fit: People with non-plaque forms of psoriasis, prior TYK2 inhibitor exposure, recent biologic or other specified systemic psoriasis treatments, active severe infections, or disqualifying chronic diseases may not receive benefit or be eligible.

Why it matters

Potential benefit: If successful, the drug could offer clearer skin and symptom relief for people with moderate to severe plaque psoriasis as an additional targeted oral treatment option.

How similar studies have performed: Selective TYK2 inhibitors have produced positive results in other trials and at least one TYK2 inhibitor (deucravacitinib) has been approved for plaque psoriasis, so this mechanism has demonstrated clinical success.

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

Where this trial is running

Shanghai

• Shanghai Skin Disease Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yang Zhang

Conditions Plaque Psoriasis; Moderate to Severe Plaque Psoriasis