A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis

Usynova Pharmaceuticals Ltd.

Status: Enrolling

Conditions: Moderate to Severe Plaque Psoriasis; Plaque Psoriasis

Treatments: Drug: Tyk2 inhibitor; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07234591

CN101

Details and patient eligibility

About

A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 4 patient groups, including a placebo group

dose level 1

Experimental group

Treatment:

Drug: Tyk2 inhibitor

dose level 2

Experimental group

Treatment:

Drug: Tyk2 inhibitor

dose level 3

Experimental group

Treatment:

Drug: Tyk2 inhibitor

placebo

Placebo Comparator group

Treatment:

Drug: Placebo