Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis

Study Overview
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Brief Summary
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This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment. Pharmacokinetic samples will be obtained pre-and post treatment.

Official Title
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Proof of Principle, Randomized, Parallel-Group, Double-Blind, Vehicle-Controlled, Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis

Conditions
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Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: E6201 0.005%
* Drug: E6201 0.01%
* Drug: E6201 0.03%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Males and females 18 years or older with a clinical diagnosis of mild-to-moderate plaque-type psoriasis for ≥12 months prior to screening Female participants postmenopausal >1 year or surgically sterile Two representative and similar target lesions for the condition, each of 15-25 centimeters squared (cm^2), up to 50 cm^2 in surface area Target lesion severity score of 4-8 on a scale of 0 to 12, where, in the opinion of the Investigator, 0 equals no evidence of disease and 12 equals severe induration, erythema, scaling, and pruritus Prescription medications, if applicable, for chronic conditions allowed but must be on a stable regimen prior to and during the study; this is also applicable for dietary supplements and over-the-counter (OTC) drugs Participants able and willing to give informed consent EXCLUSION CRITERIA Use of any, concomitant, topical treatment for psoriasis, excluding emollients Use of any, concomitant, systemic treatment for psoriasis, including ultraviolet radiation (UVR) light Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, psychiatric, musculoskeletal, rheumatologic, or cardiovascular system abnormalities Evidence of any clinically significant deviation from normal with respect to medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory determinations. If any participant has an abnormal clinical laboratory test finding that meets specified criteria, that participant will be re-tested by repeated blood draw and clinical laboratory assessment. If the abnormal test finding is confirmed, the participant will be excluded from the study.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E6201 0.005% BID<br>Participants applied E6201 0.005% cream to a pre-identified marker lesion twice a day (BID) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. | Drug: E6201 0.005%<br> <br> Drug: Placebo<br> <br> |
| Experimental: E6201 0.01% BID<br>Participants applied E6201 0.01% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. | Drug: E6201 0.01%<br> <br> Drug: Placebo<br> <br> |
| Experimental: E6201 0.03% BID<br>Participants applied E6201 0.03% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. | Drug: E6201 0.03%<br> <br> Drug: Placebo<br> <br> |
| Experimental: E6201 0.03% QD<br>Participants applied E6201 0.03% cream to a pre-identified marker lesion once a day (QD) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. | Drug: E6201 0.03%<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Symptom Severity (TSS) at week 8. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK) |  | Up to 12 weeks |