Plaque PsoriasisNCT07234591
A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis
A study testing Tyk2 inhibitor in people with Plaque Psoriasis and Moderate to Severe Plaque Psoriasis, run by Usynova Pharmaceuticals Ltd. at 1 site in China.
Trial summary
A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis, Moderate to Severe Plaque Psoriasis
- What is being tested?
- Tyk2 inhibitor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2025to 30 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
A Study to evaluate efficacy and safety in subjects with moderate to severe Plaque Psoriasis treated with a TYK2 Inhibitor for 12 weeks
- Being tested
- Tyk2 inhibitor, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyk2 inhibitorDrug
Specific dose of Tyk2 inhibitor on specific days
PlaceboDrug
Specified dose of Placebo on specified days.
| Study group | Role | What they receive |
|---|---|---|
| dose level 1 | Experimental | Not described Receives: Drug: Tyk2 inhibitor |
| dose level 2 | Experimental | Not described Receives: Drug: Tyk2 inhibitor |
| dose level 3 | Experimental | Not described Receives: Drug: Tyk2 inhibitor |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Week 12
Measured: Baseline to Week 12
Secondary outcomes (8)
Percentage of Participants With PASI-90, PASI-100 on Week 12
Measured: Baseline to Week 12
Percentage of Participants on Week 12 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate)
Measured: Baseline to Week 12
Change From Baseline in DLQI Scores to Week 12
Measured: Baseline to Week 12
Change From Baseline in BSA to Week 12
Measured: Baseline to Week 12
Number of Participants With Adverse Events
Measured: From enrollment to Day 112
Mean steady-state plasma concentration of the drug (Cav,ss)
Measured: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84
Steady-state trough plasma concentration of the drug (Ctrough, ss)
Measured: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84
The area under the steady-state blood drug concentration-time curve (AUCss)
Measured: Day 1, Day 8, Day 15, Day 29, Day 57, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start21 Oct 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Usynova Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234591
- Sponsor's protocol ID
- CN101
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No