CClinicalTrials.gg
Sign In
CompletedNCT03235024Updated Oct 10, 2022Results posted

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

A Phase 2 interventional study of B244 and Vehicle in Atopic Dermatitis Eczema, sponsored by AOBiome LLC. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-10.

Sponsored by AOBiome LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Atopic Dermatitis Eczema
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalB244

    B244 suspension

  • BiologicalVehicle

    Vehicle suspension

05

What researchers measure

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.

    Time frame: Baseline to Day 42

Secondary outcomes

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

    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.

    Time frame: Baseline to Day 28

Other outcomes

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

    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.

    Time frame: Baseline to Day 28

  2. Change in the Skindex 16 Score Between the Active and Vehicle Group

    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.

    Time frame: Baseline to Day 28

  3. Change in the IGA Score Between the Active and Vehicle Groups

    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).

    Time frame: Baseline to Day 28

  4. Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group

    Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.

    Time frame: Baseline to Day 28

  5. Difference in Biomarkers Between Active and Vehicle Groups.

    To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers.

    Time frame: Baseline and Day 28

  6. Microbial Content

    Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.

    Time frame: Baseline and Day 28

06

Results

Posted Oct 10, 2022

Participant flow

Participant flow — Overall Study
MilestoneB244Vehicle
Started6161
Completed5551
Not completed610
Withdrew: Adverse event22
Withdrew: Death10
Withdrew: Lost to follow-up25
Withdrew: Protocol violation10
Withdrew: Withdrawal by subject03

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline to Day 42
Reported as:
Count of participants · Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
ParticipantsB244Vehicle
At Least 1 Treatment-Related TEAE24
At Least 1 Treatment-Related Grade 3 or 4 TEAE00
At Least 1 Treatment-Related Serious TEAE00
SecondaryChange in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups

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.

Time frame:
Baseline to Day 28
Reported as:
Mean · score on a scale
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups
score on a scaleB244Vehicle
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups-5.7 ± 4.46-5.9 ± 5.90
Other pre-specifiedChange in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group

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.

Time frame:
Baseline to Day 28
Reported as:
Mean · score on a scale
Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group
score on a scaleB244Vehicle
Week 2 Change from Baseline-1.5 ± 2.23-0.6 ± 1.92
Week 4 Change from Baseline-1.8 ± 2.81-1.4 ± 2.32
Statistical analysis
  • B244 vs Vehicle · t-test, 1 sided · p = 0.0228 (At Week 2)
Other pre-specifiedChange in the Skindex 16 Score Between the Active and Vehicle Group

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.

Time frame:
Baseline to Day 28
Reported as:
Mean · score on a scale
Change in the Skindex 16 Score Between the Active and Vehicle Group
score on a scaleB244Vehicle
Change in the Skindex 16 Score Between the Active and Vehicle Group-0.2 ± 5.74-0.8 ± 1.28
Other pre-specifiedChange in the IGA Score Between the Active and Vehicle Groups

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).

Time frame:
Baseline to Day 28
Reported as:
Mean · score on a scale
Change in the IGA Score Between the Active and Vehicle Groups
score on a scaleB244Vehicle
Change in the IGA Score Between the Active and Vehicle Groups-0.6 ± 0.82-0.7 ± 0.94
Other pre-specifiedDifference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group

Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.

Time frame:
Baseline to Day 28
Reported as:
Mean · average scratching events per hour
Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group
average scratching events per hourB244Vehicle
Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group-3.4 ± 8.263 ± 7.92
Other pre-specifiedDifference in Biomarkers Between Active and Vehicle Groups.

To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers.

Time frame:
Baseline and Day 28

No measurements were reported for this outcome.

Other pre-specifiedMicrobial Content

Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.

Time frame:
Baseline and Day 28

No measurements were reported for this outcome.

Adverse events

Collected over Baseline to Week 6.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
B2441/61 (1.6%)1/61 (1.6%)16/61 (26.2%)
Vehicle0/61 (0%)0/61 (0%)14/61 (23%)
Most frequent serious events
Most frequent serious events
EventB244Vehicle
ArteriosclerosisVascular disorders1/610/61
Most frequent other events
Showing 10 of 31
Most frequent other events
EventB244Vehicle
HeadacheNervous system disorders3/613/61
BronchitisInfections and infestations2/610/61
Upper respiratory infectionInfections and infestations2/611/61
Dermatitis atopicSkin and subcutaneous tissue disorders0/612/61
Dermatitis contactSkin and subcutaneous tissue disorders2/611/61
PruritusSkin and subcutaneous tissue disorders0/612/61
SuperinfectionInfections and infestations1/610/61
Urinary tract infectionInfections and infestations0/611/61
Viral upper respiratory tract infectionInfections and infestations1/611/61
DermatitisSkin and subcutaneous tissue disorders1/610/61

Baseline characteristics

Intent to Treat (ITT) population included all randomized subjects.

Age, Customized
Age, Customized(Participants)B244VehicleTotal
< 30 years121224
≥ 30 years494998
Sex: Female, Male
Sex: Female, Male(Participants)B244VehicleTotal
Female364480
Male251742
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)B244VehicleTotal
Hispanic or Latino151025
Not Hispanic or Latino465096
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)B244VehicleTotal
American Indian or Alaska Native101
Asian549
Native Hawaiian or Other Pacific Islander011
Black or African American252853
White272754
More than one race000
Unknown or Not Reported314
Weight
Weight(kg)B244VehicleTotal
Mean85.420 ± 24.902085.542 ± 22.879485.481 ± 23.8132
BMI
BMI(kg/m^2)B244VehicleTotal
Mean30.027 ± 9.223730.551 ± 7.028630.289 ± 8.1702
BMI Category
BMI Category(Participants)B244VehicleTotal
<20 kg/m^2527
20 to <25 kg/m^2151227
25 to <30 kg/m^2122234
≥30 kg/m^2292554
Smoking History
Smoking History(Participants)B244VehicleTotal
Never323971
Former10313
Current191938
07

Study locations

17 sites
  • Central Research Associates
    Birmingham, Alabama 35205, United States
  • Elite Clinical Studies
    Phoenix, Arizona 85018, United States
  • Encino Research Center
    Encino, California 91436, United States
  • Orange County Research Center
    Tustin, California 92780, United States
  • Neostart Corporation d.b.a AGA Clinical Trials
    Hialeah, Florida 33012, United States
  • Clinical Neuroscience Solution, Inc
    Jacksonville, Florida 32256, United States
  • FXM Research Corp.
    Miami, Florida 33175, United States
  • FXM Research Miramar
    Miramar, Florida 33027, United States
  • Clinical Neuroscience Solution, Inc
    Orlando, Florida 32801, United States
  • Clinical Research Trials of Florida, Inc.
    Tampa, Florida 33607, United States
  • Columbus Regional Research Institute
    Columbus, Georgia 31904, United States
  • DeNova Research dba Arano, LLC
    Chicago, Illinois 60611, United States
  • Clarkston Skin Research
    Clarkston, Michigan 48349, United States
  • MediSearch Clinical Trials
    Saint Joseph, Missouri 64506, United States
  • LoveLace Scientific Resources
    Albuquerque, New Mexico 87108, United States
  • Central Sooner Research
    Norman, Oklahoma 73071, United States
  • Paddington Testing Co.
    Philadelphia, Pennsylvania 19103, United States
08

References and documents

Study documents

  • Study protocol · Oct 5, 2018
  • Statistical analysis plan · Oct 30, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03235024
Lead sponsor
AOBiome LLC
Collaborators
Veristat, Inc.
Responsible party
Sponsor
First posted
Aug 1, 2017
Start date
Jan 15, 2018
Primary completion
Feb 27, 2019
Completion
Mar 20, 2019
Results posted
Oct 10, 2022
Last update
Oct 10, 2022

Study contacts

Judith Ng-Cashin, MD
study director · Chief Medical Officer
Spiros Jamas, ScD
study director · AOBiome LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dermatitis, Atopic→

Other studies from this sponsor

AOBiome LLC

Start the discussion