Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.

Official Title
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A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: DUR-928 Topical Solution
* Drug: Vehicle Topical Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a male or non-pregnant female 18 years of age or older. Subject has provided written informed consent. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months. Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 2/Baseline. Males (or their female partner) must agree to use an effective method of birth control throughout the study. Subject has two similar contralateral Target Plaques. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation. Exclusion Criteria: Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis. Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient during the study. Subject is currently enrolled in an investigational drug or device study. Subject has been previously enrolled in this study and treated with test article. Other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DUR-928 Topical Solution<br>DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. | Drug: DUR-928 Topical Solution<br>* Topical solution containing active drug<br>|
| Placebo Comparator: Vehicle Topical Solution<br>Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. | Drug: Vehicle Topical Solution<br>* Topical solution containing no active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. | The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe. | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) | 
| The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) | The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe. | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) | 
| The Change From Baseline as Assessed by the Target Plaque Area. | The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured. | Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported) | 
| The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. | The I-NRS score is based on an 11-point scale where 0 represents no itching and 10 represents worst itch imaginable. | Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported) |