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

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ClinicalTrials.gov Identifier: NCT03235024
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Veristat, Inc.
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Biological: B244 Biological: Vehicle Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
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
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: 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

Biological: B244
B244 suspension

Placebo Comparator: Vehicle

Vehicle, 30ml/bottle

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

Biological: Vehicle
Vehicle suspension




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Baseline to Day 42 ]
    Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.


Secondary Outcome Measures :
  1. Change in Atopic Dermatitis Area Severity Index (EASI) Score between the active and vehicle groups [ Time Frame: Baseline to Day 28 ]

Other Outcome Measures:
  1. Change in Visual Analog Scale (VAS) Score for Pruritus between the active and vehicle group [ Time Frame: Baseline and Day 28 ]
  2. Change in the Skindex 16 Score between the active and vehicle group [ Time Frame: Baseline and Day 28 ]
  3. Change in the IGA score between the active and vehicle groups [ Time Frame: Baseline and Day 28 ]
  4. Difference in Actigraphy Movement Count per Hour during the night between the active and vehicle group [ Time Frame: Baseline to Day 28 ]
  5. Difference in biomarkers between active and vehicle groups [ Time Frame: Baseline and Day 28 ]
    To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers

  6. Microbial content [ Time Frame: Baseline and Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235024


Contacts
Contact: Robert Calhoun 617.639.9980 RCalhoun@aobiome.com
Contact: Masha Gaber 617.639.9980

Locations
United States, Alabama
Central Research Associates Active, not recruiting
Birmingham, Alabama, United States, 35205
United States, Arizona
Elite Clinical Studies Recruiting
Phoenix, Arizona, United States, 85018
Contact: Nicole Ossino    602-788-4868    Nicole@eliteclinicalstudies.com   
United States, California
Encino Research Center Recruiting
Encino, California, United States, 91436
Contact: Sarah Emert    818-788-5060    sarah@drraoof.com   
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Contact: Joel Neutel, MD    714-550-9990      
United States, Florida
Neostart Corporation d.b.a AGA Clinical Trials Active, not recruiting
Hialeah, Florida, United States, 33012
Clinical Neuroscience Solution, Inc Recruiting
Jacksonville, Florida, United States, 32256
Contact: Kaylie Conlin    904-287-5757    kconlin@cnshealthcare.com   
FXM Research Corp. Recruiting
Miami, Florida, United States, 33175
Contact: Yaneysi Alonso         
Contact    305 220 5222      
Principal Investigator: Hector Wiltz, MD         
FXM Research Miramar Recruiting
Miramar, Florida, United States, 33027
Contact: Maritza Diego    954-430-1097      
Principal Investigator: Francisco Flores, MD         
Clinical Neuroscience Solution, Inc Recruiting
Orlando, Florida, United States, 32801
Contact: Tania Alidina    407-425-5100    talidina@cnshealthcare.com   
Clinical Research Trials of Florida, Inc. Recruiting
Tampa, Florida, United States, 33607
Contact: Ricardo Alpizar    813-873-8102    ralpizar@crtfi.com   
United States, Georgia
Columbus Regional Research Institute Recruiting
Columbus, Georgia, United States, 31904
Contact: Alyssa Middlebrook       amiddlebrook@iacthealth.com   
United States, Illinois
DeNova Research dba Arano, LLC Recruiting
Chicago, Illinois, United States, 60611
Contact: Selika Gutierrez-Borst       Selika@denovaresearch.com   
United States, Michigan
Clarkston Skin Research Recruiting
Clarkston, Michigan, United States, 48349
Contact: Brianna Cole, CCRC    248-620-3376 ext 116      
Principal Investigator: Wendy McFalda, MD         
United States, Missouri
MediSearch Clinical Trials Active, not recruiting
Saint Joseph, Missouri, United States, 64506
United States, New Mexico
LoveLace Scientific Resources Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Bonnie Gutierrez, LPN       bgutierrez@lrri.org   
United States, Oklahoma
Central Sooner Research Recruiting
Norman, Oklahoma, United States, 73071
Contact: Kurt Smith       ksmith@centralsooner.com   
United States, Pennsylvania
Paddington Testing Co. Active, not recruiting
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
AOBiome LLC
Veristat, Inc.
Investigators
Study Director: Judith Ng-Cashin, MD Chief Medical Officer
Study Director: Spiros Jamas, ScD AOBiome LLC

Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT03235024     History of Changes
Other Study ID Numbers: ADB244-001
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases