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

Phase 2

Completed

Conditions: Atopic Dermatitis Eczema

Interventions: Biological: B244
Biological: Vehicle

Registration Number: NCT03235024

Lead Sponsor: AOBiome LLC

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 122

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B244	B244	B244 suspension in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.
Vehicle	Vehicle	Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups	Baseline to Day 28	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.

Trial Locations

Locations (16): Encino Research Center
🇺🇸
Encino, California, United States
FXM Research Miramar
🇺🇸
Miramar, Florida, United States
Clarkston Skin Research
🇺🇸
Clarkston, Michigan, United States
Columbus Regional Research Institute
🇺🇸
Columbus, Georgia, United States
Neostart Corporation d.b.a AGA Clinical Trials
🇺🇸
Hialeah, Florida, United States
Central Sooner Research
🇺🇸
Norman, Oklahoma, United States
Paddington Testing Co.
🇺🇸
Philadelphia, Pennsylvania, United States
Central Research Associates
🇺🇸
Birmingham, Alabama, United States
Elite Clinical Studies
🇺🇸
Phoenix, Arizona, United States
Clinical Research Trials of Florida, Inc.
🇺🇸
Tampa, Florida, United States
Orange County Research Center
🇺🇸
Tustin, California, United States
FXM Research Corp.
🇺🇸
Miami, Florida, United States
MediSearch Clinical Trials
🇺🇸
Saint Joseph, Missouri, United States
Clinical Neuroscience Solution, Inc
🇺🇸
Orlando, Florida, United States
LoveLace Scientific Resources
🇺🇸
Albuquerque, New Mexico, United States
DeNova Research dba Arano, LLC
🇺🇸
Chicago, Illinois, United States