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

NCT07234591 | Recruiting

• 1 other identifier: CN101
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis; Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (4)

dose level 1

EXPERIMENTAL

Drug: Tyk2 inhibitor

dose level 2

EXPERIMENTAL

Drug: Tyk2 inhibitor

dose level 3

EXPERIMENTAL

Drug: Tyk2 inhibitor

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tyk2 inhibitor DRUG

Specific dose of Tyk2 inhibitor on specific days

dose level 1; dose level 2; dose level 3

Placebo DRUG

Specified dose of Placebo on specified days.

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Usynova Pharmaceuticals Ltd.: lead

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, China

RECRUITING

Central Study Contacts

Yang Zhang

CONTACT

+8613636393195; yang_zhang@usynova.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 21, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

CN (1)