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

NCT ID: NCT07234591

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-21

Study Completion Date

2026-05-30

Brief Summary

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

Detailed Description

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Conditions

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Plaque Psoriasis Moderate to Severe Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dose level 1

Group Type EXPERIMENTAL

Tyk2 inhibitor

Intervention Type DRUG

Specific dose of Tyk2 inhibitor on specific days

dose level 2

Group Type EXPERIMENTAL

Tyk2 inhibitor

Intervention Type DRUG

Specific dose of Tyk2 inhibitor on specific days

dose level 3

Group Type EXPERIMENTAL

Tyk2 inhibitor

Intervention Type DRUG

Specific dose of Tyk2 inhibitor on specific days

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Specified dose of Placebo on specified days.

Interventions

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Tyk2 inhibitor

Specific dose of Tyk2 inhibitor on specific days

Intervention Type DRUG

Placebo

Specified dose of Placebo on specified days.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Usynova Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Skin Disease Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Zhang

Role: CONTACT

+8613636393195

Other Identifiers

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CN101

Identifier Type: -

Identifier Source: org_study_id

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