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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235024
Recruitment Status : Completed
First Posted : August 1, 2017
Results First Posted : October 10, 2022
Last Update Posted : October 10, 2022
Sponsor:
Collaborator:
Veristat, Inc.
Information provided by (Responsible Party):
AOBiome LLC

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE August 1, 2017
Results First Submitted Date  ICMJE July 19, 2022
Results First Posted Date  ICMJE October 10, 2022
Last Update Posted Date October 10, 2022
Actual Study Start Date  ICMJE January 15, 2018
Actual Primary Completion Date February 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2022)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • 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.
  • Change in Atopic Dermatitis Area Severity Index (EASI) Score between the active and vehicle groups [ Time Frame: Baseline to Day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2022)
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • Change in Visual Analog Scale (VAS) Score for Pruritus between the active and vehicle group [ Time Frame: Baseline to Day 28 ]
  • Change in the Skindex 16 Score between the active and vehicle group [ Time Frame: Baseline to Day 28 ]
Current Other Pre-specified Outcome Measures
 (submitted: August 23, 2022)
  • Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group [ Time Frame: Baseline to Day 28 ]
    VAS (Visual Analog Scale) was performed as a measure of pruritus. The VAS is composed of a 10-cm line divided into a scale from 0 to 10, and subjects were to indicate the score that best represented the intensity of their itching over the 24-hour period before each visit where a higher score indicated greater severity in pruritus.
  • Change in the Skindex 16 Score Between the Active and Vehicle Group [ Time Frame: Baseline to Day 28 ]
    The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.
  • Change in the IGA Score Between the Active and Vehicle Groups [ Time Frame: Baseline to Day 28 ]
    IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).
  • Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group [ Time Frame: Baseline to Day 28 ]
    Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.
  • 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.
  • Microbial Content [ Time Frame: Baseline and Day 28 ]
    Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
Original Other Pre-specified Outcome Measures
 (submitted: July 31, 2017)
  • Difference in Actigraphy Movement Count per Hour during the night between the active and vehicle group [ Time Frame: Baseline to Day 28 ]
  • 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
  • Microbial content [ Time Frame: Baseline and Day 28 ]
 
Descriptive Information
Brief Title  ICMJE Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Atopic Dermatitis Eczema
Intervention  ICMJE
  • Biological: B244
    B244 suspension
  • Biological: Vehicle
    Vehicle suspension
Study Arms  ICMJE
  • 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.

    Intervention: Biological: B244
  • 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.

    Intervention: Biological: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2019)
122
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2017)
130
Actual Study Completion Date  ICMJE March 20, 2019
Actual Primary Completion Date February 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03235024
Other Study ID Numbers  ICMJE ADB244-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AOBiome LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AOBiome LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Veristat, Inc.
Investigators  ICMJE
Study Director: Judith Ng-Cashin, MD Chief Medical Officer
Study Director: Spiros Jamas, ScD AOBiome LLC
PRS Account AOBiome LLC
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP