AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.

Official Title
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A Multicenter, Randomized, Double-Blind, 12-Week Study Of The Safety And Efficacy Of AN2728 Versus AN2728 Vehicle In The Treatment Of Patients With Mild-To-Moderate Plaque-Type Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: AN2728 ointment, 2%
* Drug: Ointment Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits Women of childbearing potential must agree to use contraception for the entire study period Exclusion Criteria: Any dermatological conditions that could interfere with clinical evaluations Concurrent or recent use of certain topical or systemic medications without a sufficient washout period Significant confounding conditions as assessed by study doctor Participated in any other trial of an investigational drug within 30 days or participation in a research study concurrent with this study Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil) Use of a beta-blocking medication (e.g., propranolol) if the dose has not been stabilized for at least 3 months Pregnancy or lactation

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: AN2728 ointment, 2%<br>AN2728 ointment, 2% | Drug: AN2728 ointment, 2%<br>* AN2728 ointment, 2%, applied twice daily for 12 weeks<br>|
| Placebo Comparator: Ointment Vehicle<br>Ointment Vehicle | Drug: Ointment Vehicle<br>* Ointment Vehicle, applied twice daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84 | PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84. | Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70 | PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70. | Day 14, Day 28, Day 42, Day 56, Day 70 | 
| Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84 | Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported. | Baseline (Day 1), Day 84 | 
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE. | Baseline (Day 1) up to Day 84 | 
| Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant's usual function b) moderate =AEs interfered to some extent with participant's usual function c) severe =AEs interfered significantly with participant's usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported. | Baseline (Day 1) up to Day 84 | 
| Number of Participants With Local Tolerability Symptoms: Burning/Stinging | Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported. | Baseline (Day 1) up to Day 84 | 
| Number of Participants With Local Tolerability Symptoms: Pruritus | Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported. | Baseline (Day 1) up to Day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis