Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.

Official Title
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A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Efficacy and Safety of ME3183 Administered Orally in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: ME3183
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female, ages 18 to 75 years Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration. Exclusion Criteria: Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease. Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening. Hepatitis B surface antigen positive at Screening. History of HIV or Positive for the HIV antibodies at Screening. History of allergy to any component of the study treatment. Active tuberculosis (TB) or a history of incompletely treated TB. Active infection (bacteria, viral, fungal, etc.) requiring treatment with systemic antibiotics within 4 weeks of Screening. Malignancy or history of malignancy except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence. Pregnant or breast feeding Received ustekinumab, secukinumab, brodalumab, ixekizumab, guselkumab, risankizumab, tildrakizumab, or briakinumab within 24 weeks of first administration of study treatment. Received TNF-α inhibitor(s)/blocker(s) within 8 weeks of first administration of study treatment. Received rituximab within 24 weeks of first administration of study treatment. Received phototherapy or any systemic medications/treatments within 4 weeks of the first administration of study treatment. Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ME3183 Dose 1, BID<br>Specified dose of ME3183 capsule for 16 weeks | Drug: ME3183<br>* ME3183 capsule<br>|
| Experimental: ME3183 Dose 2, QD<br>Specified dose of ME3183 capsule for 16 weeks | Drug: ME3183<br>* ME3183 capsule<br>|
| Experimental: ME3183 Dose 3, BID<br>Specified dose of ME3183 capsule for 16 weeks | Drug: ME3183<br>* ME3183 capsule<br>|
| Experimental: ME3183 Dose 4, QD<br>Specified dose of ME3183 capsule for 16 weeks | Drug: ME3183<br>* ME3183 capsule<br>|
| Placebo Comparator: Placebo<br>Placebo capsule of ME3183 for 16 weeks | Drug: Placebo<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving 75% improvement in Psoriasis Area Severity Index (PASI) Score (PASI-75) at Week 16 from Baseline |  | Baseline to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from Baseline in PASI score at all visits from Week 1 to Week 16 |  | Baseline to Week 16 | 
| Proportion of subjects achieving PASI-50, PASI-75, PASI-90, PASI-100 at all visits from Week 1 to Week 16 |  | Baseline to Week 16 | 
| Time to PASI-50 and PASI-75 |  | Baseline to Week 16 | 
| Proportion of subjects achieving a Static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) combined with 2-point reduction on the 5-point sPGA scale at all visits from Week 1 to Week 16 |  | Baseline to Week 16 | 
| Change from Baseline in affected Body Surface Area (BSA) at all visits from Week 1 to Week 16 |  | Baseline to Week 16 | 
| Change from Baseline in the Itch Numerical Rating Scale (NRS) at all visits from Week 1 to Week 16 |  | Baseline to Week 16 | 
| Percentage of subjects with at least a 5-point reduction from Baseline in the Dermatology Life Quality Index (DLQI) score at all visits from Week 1 to Week 16 |  | Baseline to Week 16 | 
| The incidence, severity, and seriousness of adverse events (AEs) reported over the 16-week Treatment Period and the 4-week Follow-up Period |  | Baseline to Week 20 |