Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.

Detailed Description
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This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.

Official Title
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A Double-Blind, Randomized Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: AN2728
* Drug: AN2728 Ointment Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female >18 years of age at time of enrollment. The clinical diagnosis of stable plaque psoriasis. Two target plaques of similar severity ≥ 5 cm2 but ≤ 100 cm2 computed by multiplying the greatest diameter of the plaque by the diameter of the plaque perpendicular to the greatest diameter. Bilaterally located (right/left) plaques on the arms or plaques located on the upper and lower trunk. Plaques located on the trunk were to be separated by at least 10 cm and designated by the Investigator as either left/right or front/back. Target plaque severity score of 2-4 (mild to moderate). Normal or not clinically significant screening laboratory results. Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits. Subjects who had the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures. Exclusion Criteria: Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below) Known sensitivity to any of the components of the study medication Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis Concomitant use of topical or systemic therapies that might alter the course of psoriasis Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (oophorectomy) Washout periods of: Topical drugs that might alter the course of psoriasis: 2 weeks Oral retinoids: 8 weeks Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks PUVA: 4 weeks UVB therapy: 4 weeks Use of emollients/moisturizers on area(s) to be treated: 2 days prior to baseline visit AIDS or AIDS related illness Concurrent participation in another drug research study or within 30 days of enrollment Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil) Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months

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 |
| --- | --- |
| Active Comparator: 1<br>AN2728 Ointment, 5% | Drug: AN2728<br>* AN2728 Ointment, 5%, twice daily for 4 weeks<br>* Other names: AN2728 Ointment, 5%;|
| Placebo Comparator: 2<br>AN2728 Ointment Vehicle | Drug: AN2728 Ointment Vehicle<br>* AN2728 Ointment Vehicle, twice daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28 | OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. | Baseline (Day 1), Day 7,14, 21, 28, 35 | 
| Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition. | Baseline (Day 1), Day 7,14, 21, 28, 35 | 
| Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition. | Baseline (Day 1), Day 7,14, 21, 28, 35 | 
| Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition. | Baseline (Day 1), Day 7,14, 21, 28, 35 | 
| Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 21 and 35 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'. | Day 7,14, 21, 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque Type Psoriasis, Topical