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NCT Number: NCT07234591

A Study to Evaluate Effectiveness 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

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Skin Disease Hospital

Shanghai, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tyk2 inhibitor

Drug

Specific dose of Tyk2 inhibitor on specific days

Placebo

Drug

Specified dose of Placebo on specified days.

Primary outcomes

  1. The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Percentage of Participants With PASI-90, PASI-100 on Week 12

    Time frame: Baseline to Week 12

  2. Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate)

    Time frame: Baseline to Week 12

  3. Change From Baseline in DLQI Scores to Week 12

    Time frame: Baseline to Week 12

  4. Change From Baseline in BSA to Week 12

    Time frame: Baseline to Week 12

  5. Number of Participants With Adverse Events

    Time frame: From enrollment to Day 112

  6. Mean steady-state plasma concentration of the drug (Cav,ss)

    Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84

  7. Steady-state trough plasma concentration of the drug (Ctrough, ss)

    Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84

  8. The area under the steady-state blood drug concentration-time curve (AUCss)

    Time frame: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Zhang

CONTACT

[email protected]

+8613636393195

Sponsors and collaborators

Lead sponsor

Usynova Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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