Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD

Detailed Description
-----------------
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the VAS scale (at least moderate). The total duration of the study will be approximately 9 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a two week washout phase before reporting for a Baseline visit. Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be conducted at Day 42 (Week 6). Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual Analog Scale (VAS). Blood and urine samples will be collected for standard safety laboratory tests and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study. Investigators plan to enroll approximately 130 total patients. Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.

Official Title
-----------------
A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis Eczema

Intervention / Treatment
-----------------
* Biological: B244
* Biological: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects ≥18 years of age In good general health as determined by a thorough medical history and physical examination, and vital signs Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of Hanifin and Rajka Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21 A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, excoriation, with the excoriation serving as the physical examination correlate of pruritus) An IGA score of 2-3 Patient has a history of AD for ≥12 months Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure Exclusion Criteria: Pregnant and lactating women by urine pregnancy testing Subjects with any significant clinical abnormalities which may interfere with study participation Any skin condition which may interfere with evaluation of AD Atopic dermatitis only on the head or scalp Subjects with Atopic dermatitis on the face Unstable or actively infected atopic dermatitis Patients suffering from pruritus from conditions other than AD Patients with chronic pruritus due to systemic disease Patients with conditions requiring inhaled steroids Have concurrent skin disease of such severity in the study area that it could interfere with the study evaluation Have active skin infections on the treatment area Have received or planning to receive topical corticosteroids, topical coal tar, topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy, oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics, glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents, systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within 2 weeks of Baseline visit. Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex® and Trexall™ or its generic versions such as Methotrexate History of being seropositive for human immunodeficiency virus (HIV) at screening by laboratory testing at Screening History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening History of renal disease Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than five times the drug's half-life, whichever is longer Use of any biologic within a period of 5 times its half-life Use of vinegar or bleach baths within 2 weeks of starting the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B244<br>B244 suspension in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day. | Biological: B244<br>* B244 suspension<br>|
| Placebo Comparator: Vehicle<br>Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day. | Biological: Vehicle<br>* Vehicle suspension<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability endpoints will consist of all adverse events reporting during the study duration. | Baseline to Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups | EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis. | Baseline to Day 28 |