A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects 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

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

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis; Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: Tyk2 inhibitor; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Zhang; Phone Number: +8613636393195; Email: yang_zhang@usynova.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai skin disease hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; Specified dose of Placebo on specified days.
Experimental: dose level 1	Drug: Tyk2 inhibitor; Specific dose of Tyk2 inhibitor on specific days
Experimental: dose level 2	Drug: Tyk2 inhibitor; Specific dose of Tyk2 inhibitor on specific days
Experimental: dose level 3	Drug: Tyk2 inhibitor; Specific dose of Tyk2 inhibitor on specific days

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With PASI-90, PASI-100 on Week 12	Baseline to Week 12
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
Number of Participants With Adverse Events	From enrollment to Day 112
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

Collaborators and Investigators

• Sponsor: Usynova Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CN101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No