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

NCT03235024 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADB244-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 17

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

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups

  Baseline to Day 28

Other Outcomes (6)

• Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group

  Baseline to Day 28

• Change in the Skindex 16 Score Between the Active and Vehicle Group

  Baseline to Day 28

• Change in the IGA Score Between the Active and Vehicle Groups

  Baseline to Day 28

Study Arms (2)

B244

ACTIVE COMPARATOR

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

Vehicle

PLACEBO COMPARATOR

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

Biological: Vehicle

Interventions

B244 BIOLOGICAL

B244 suspension

B244

Vehicle BIOLOGICAL

Vehicle suspension

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AOBiome LLC: lead
• Veristat, Inc.: collaborator

Study Sites (17)

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Neostart Corporation d.b.a AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

Clinical Neuroscience Solution, Inc

Jacksonville, Florida, 32256, United States

Location

FXM Research Corp.

Miami, Florida, 33175, United States

Location

FXM Research Miramar

Miramar, Florida, 33027, United States

Location

Clinical Neuroscience Solution, Inc

Orlando, Florida, 32801, United States

Location

Clinical Research Trials of Florida, Inc.

Tampa, Florida, 33607, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

DeNova Research dba Arano, LLC

Chicago, Illinois, 60611, United States

Location

Clarkston Skin Research

Clarkston, Michigan, 48349, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

LoveLace Scientific Resources

Albuquerque, New Mexico, 87108, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Paddington Testing Co.

Philadelphia, Pennsylvania, 19103, United States

Location

Results Point of Contact

• Title: Hyun Kim, Vice President Clinical Operations
• Organization: AOBiome Therapeutics

hkim@aobiome.com

617-639-9980

Study Officials

• Judith Ng-Cashin, MD

  Chief Medical Officer

  STUDY DIRECTOR

• Spiros Jamas, ScD

  AOBiome LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind study. Participants will be assigned to study treatment in accordance with the randomization schedule generated for the allocation of vehicle or B244 prior to the initiation of the trial. Randomization will be centrally-based and performed using an appropriate IWRS (an automated randomization system). Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 1, 2017
• Study Start: January 15, 2018
• Primary Completion: February 27, 2019
• Study Completion: March 20, 2019
• Last Updated: October 10, 2022
• Results First Posted: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)