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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUsynova Pharmaceuticals Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tyk2 inhibitor

    Drug

    Specific dose of Tyk2 inhibitor on specific days

  • Placebo

    Drug

    Specified dose of Placebo on specified days.

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: dose level 1Experimental treatment 1 intervention
Group B: dose level 2Experimental treatment 1 intervention
Group C: dose level 3Experimental treatment 1 intervention
Group D: placeboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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