Clinical trial NCT03235024: Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis Eczema
Lead sponsor: AOBiome LLC
Sponsor class: INDUSTRY
Collaborators: name: Veristat, Inc.
First posted: 2017-08-01
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Baseline to Day 42
Secondary outcomes:
measure: Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups
timeFrame: Baseline to Day 28
Other outcomes:
measure: Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group
timeFrame: Baseline to Day 28
measure: Change in the Skindex 16 Score Between the Active and Vehicle Group
timeFrame: Baseline to Day 28
measure: Change in the IGA Score Between the Active and Vehicle Groups
timeFrame: Baseline to Day 28
measure: Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group
timeFrame: Baseline to Day 28
measure: Difference in Biomarkers Between Active and Vehicle Groups.
timeFrame: Baseline and Day 28
measure: Microbial Content
timeFrame: Baseline and Day 28
Locations:
city: Birmingham
country: United States
facility: Central Research Associates
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Encino
country: United States
facility: Encino Research Center
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Hialeah
country: United States
facility: Neostart Corporation d.b.a AGA Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solution, Inc
state: Florida
city: Miami
country: United States
facility: FXM Research Corp.
state: Florida
city: Miramar
country: United States
facility: FXM Research Miramar
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solution, Inc
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc.
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Chicago
country: United States
facility: DeNova Research dba Arano, LLC
state: Illinois
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Albuquerque
country: United States
facility: LoveLace Scientific Resources
state: New Mexico
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Paddington Testing Co.
state: Pennsylvania
Study officials:
affiliation: Chief Medical Officer
name: Judith Ng-Cashin, MD
role: STUDY_DIRECTOR
affiliation: AOBiome LLC
name: Spiros Jamas, ScD
role: STUDY_DIRECTOR
References: