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

NCT ID: NCT03235024

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-03-20

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.

Conditions

Atopic Dermatitis Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

B244

Intervention Type: BIOLOGICAL

B244 suspension

Vehicle

Vehicle, 30ml/bottle

Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: BIOLOGICAL

Vehicle suspension

Interventions

B244

B244 suspension

Intervention Type: BIOLOGICAL

Vehicle

Vehicle suspension

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veristat, Inc.

OTHER

Sponsor Role: collaborator

AOBiome LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Ng-Cashin, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Spiros Jamas, ScD

Role: STUDY_DIRECTOR

AOBiome LLC

Locations

Central Research Associates

Birmingham, Alabama, United States

Elite Clinical Studies

Phoenix, Arizona, United States

Encino Research Center

Encino, California, United States

Orange County Research Center

Tustin, California, United States

Neostart Corporation d.b.a AGA Clinical Trials

Hialeah, Florida, United States

Clinical Neuroscience Solution, Inc

Jacksonville, Florida, United States

FXM Research Corp.

Miami, Florida, United States

FXM Research Miramar

Miramar, Florida, United States

Clinical Neuroscience Solution, Inc

Orlando, Florida, United States

Clinical Research Trials of Florida, Inc.

Tampa, Florida, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

DeNova Research dba Arano, LLC

Chicago, Illinois, United States

Clarkston Skin Research

Clarkston, Michigan, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

LoveLace Scientific Resources

Albuquerque, New Mexico, United States

Central Sooner Research

Norman, Oklahoma, United States

Paddington Testing Co.

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ADB244-001

Identifier Type: -

Identifier Source: org_study_id