A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).

Official Title
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A Multicenter, Double-Blind, Randomized, Vehicle-Controlled Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 Gel in Subjects With Plaque Psoriasis

Conditions
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Psoriatic Plaque

Intervention / Treatment
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* Drug: ESR-114
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a history of plaque psoriasis for at least 6 months. Subject has PGA of mild (2) or moderate (3) at Day 1. Subject has total LSS of ≥6 at Day 1. Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1. Exclusion Criteria: Subject has non-plaque psoriasis at Screening and Day 1. Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day 1. Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESR-114 1.5%<br>ESR-114 1.5% Topical Gel BID for 6 weeks | Drug: ESR-114<br>* ESR-114 Topical Gel<br>|
| Experimental: ESR-114 5.0%<br>ESR-114 5.0% Topical Gel BID for 6 weeks | Drug: ESR-114<br>* ESR-114 Topical Gel<br>|
| Placebo Comparator: Vehicle Gel<br>Placebo Topical Gel BID for 6 weeks | Other: Placebo<br>* Placebo Topical Gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Lesion Severity Score | Change from Baseline in Total Lesion Severity Score (sum of scores for Induration, Erythema, & Desquamation; score range: 0-12; lower score is better outcome) at Week 6 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with clear or almost clear on the Physician Global Assessment | Proportion of subjects with clear or almost clear on the Physician Global Assessment (PGA) at Week 6 | 6 weeks | 
| Proportion of subjects with PASI75 | Proportion of subjects with PASI75 at Week 6 | 6 weeks | 
| Change from Baseline in erythema score over time | Change from Baseline in erythema score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6 | 6 weeks | 
| Change from Baseline in induration score over time | Change from Baseline in induration score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6 | 6 weeks | 
| Change from Baseline in desquamation score over time | Change from Baseline in desquamation score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6 | 6 weeks |