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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis Eczema
Interventions Biological: B244
Biological: Vehicle
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title B244 Vehicle
Hide Arm/Group Description

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Period Title: Overall Study
Started 61 61
Completed 55 51
Not Completed 6 10
Reason Not Completed
Adverse Event             2             2
Death             1             0
Lost to Follow-up             2             5
Protocol Violation             1             0
Withdrawal by Subject             0             3
Arm/Group Title B244 Vehicle Total
Hide Arm/Group Description

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Total of all reporting groups
Overall Number of Baseline Participants 61 61 122
Hide Baseline Analysis Population Description
Intent to Treat (ITT) population included all randomized subjects.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
< 30 years
12
  19.7%
12
  19.7%
24
  19.7%
≥ 30 years
49
  80.3%
49
  80.3%
98
  80.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Female
36
  59.0%
44
  72.1%
80
  65.6%
Male
25
  41.0%
17
  27.9%
42
  34.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Hispanic or Latino
15
  24.6%
10
  16.4%
25
  20.5%
Not Hispanic or Latino
46
  75.4%
50
  82.0%
96
  78.7%
Unknown or Not Reported
0
   0.0%
1
   1.6%
1
   0.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
American Indian or Alaska Native
1
   1.6%
0
   0.0%
1
   0.8%
Asian
5
   8.2%
4
   6.6%
9
   7.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.6%
1
   0.8%
Black or African American
25
  41.0%
28
  45.9%
53
  43.4%
White
27
  44.3%
27
  44.3%
54
  44.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   4.9%
1
   1.6%
4
   3.3%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 61 participants 61 participants 122 participants
85.420  (24.9020) 85.542  (22.8794) 85.481  (23.8132)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 61 participants 61 participants 122 participants
30.027  (9.2237) 30.551  (7.0286) 30.289  (8.1702)
BMI Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
<20 kg/m^2
5
   8.2%
2
   3.3%
7
   5.7%
20 to <25 kg/m^2
15
  24.6%
12
  19.7%
27
  22.1%
25 to <30 kg/m^2
12
  19.7%
22
  36.1%
34
  27.9%
≥30 kg/m^2
29
  47.5%
25
  41.0%
54
  44.3%
Smoking History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Never
32
  52.5%
39
  63.9%
71
  58.2%
Former
10
  16.4%
3
   4.9%
13
  10.7%
Current
19
  31.1%
19
  31.1%
38
  31.1%
1.Primary Outcome
Title Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Hide Description Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
Time Frame Baseline to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population included all randomized subjects.
Arm/Group Title B244 Vehicle
Hide Arm/Group Description:

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Overall Number of Participants Analyzed 61 61
Measure Type: Count of Participants
Unit of Measure: Participants
At Least 1 Treatment-Related TEAE
2
   3.3%
4
   6.6%
At Least 1 Treatment-Related Grade 3 or 4 TEAE
0
   0.0%
0
   0.0%
At Least 1 Treatment-Related Serious TEAE
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.
Arm/Group Title B244 Vehicle
Hide Arm/Group Description:

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Overall Number of Participants Analyzed 56 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
-5.7  (4.46) -5.9  (5.90)
3.Other Pre-specified Outcome
Title Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.
Arm/Group Title B244 Vehicle
Hide Arm/Group Description:

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Overall Number of Participants Analyzed 56 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B244, Vehicle
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments A sample size of 52 per group would achieve >80% power to reject the null hypothesis of equal means when the population mean difference is μ1 - μ2 = (-1.4) - (-5.3) = 3.9 with a standard deviation for both groups of 7.0 and with a significance level (alpha) of 0.025 using a 1-sided 2-sample equal variance t-test.
Statistical Test of Hypothesis P-Value 0.0228
Comments At Week 2
Method t-test, 1 sided
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Change in the Skindex 16 Score Between the Active and Vehicle Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.
Arm/Group Title B244 Vehicle
Hide Arm/Group Description:

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Overall Number of Participants Analyzed 56 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.2  (5.74) -0.8  (1.28)
5.Other Pre-specified Outcome
Title Change in the IGA Score Between the Active and Vehicle Groups
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.
Arm/Group Title B244 Vehicle
Hide Arm/Group Description:

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Overall Number of Participants Analyzed 56 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.6  (0.82) -0.7  (0.94)
6.Other Pre-specified Outcome
Title Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28 with data collected from Actigraphy watches (subjects with missing data were excluded from analysis).
Arm/Group Title B244 Vehicle
Hide Arm/Group Description:

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Overall Number of Participants Analyzed 7 4
Mean (Standard Deviation)
Unit of Measure: average scratching events per hour
-3.4  (8.26) 3  (7.92)
7.Other Pre-specified Outcome
Title Difference in Biomarkers Between Active and Vehicle Groups.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this exploratory endpoint.
Arm/Group Title B244 Vehicle
Hide Arm/Group Description:

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Microbial Content
Hide Description Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this exploratory endpoint.
Arm/Group Title B244 Vehicle
Hide Arm/Group Description:

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline to Week 6.
Adverse Event Reporting Description All AEs occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. Adverse events believed to be possibly related to IP must have been followed until their resolution.
 
Arm/Group Title B244 Vehicle
Hide Arm/Group Description

B244 suspension (4x10E9 cells/ml) in 30ml/bottle

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

B244: B244 suspension

Vehicle, 30ml/bottle

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

Vehicle: Vehicle suspension

All-Cause Mortality
B244 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   1/61 (1.64%)      0/61 (0.00%)    
Hide Serious Adverse Events
B244 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/61 (1.64%)      0/61 (0.00%)    
Vascular disorders     
Arteriosclerosis   1/61 (1.64%)  1 0/61 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
B244 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/61 (26.23%)      14/61 (22.95%)    
Ear and labyrinth disorders     
Ear swelling   1/61 (1.64%)  0/61 (0.00%) 
Gastrointestinal disorders     
Abdominal Discomfort   1/61 (1.64%)  0/61 (0.00%) 
Diarrhoea   1/61 (1.64%)  0/61 (0.00%) 
Lip Swelling   1/61 (1.64%)  0/61 (0.00%) 
Toothache   0/61 (0.00%)  1/61 (1.64%) 
General disorders     
Application site pain   1/61 (1.64%)  1/61 (1.64%) 
Application site pruritus   1/61 (1.64%)  0/61 (0.00%) 
Immune system disorders     
Seasonal allergy   0/61 (0.00%)  1/61 (1.64%) 
Infections and infestations     
Bronchitis   2/61 (3.28%)  0/61 (0.00%) 
Superinfection   1/61 (1.64%)  0/61 (0.00%) 
Upper respiratory infection   2/61 (3.28%)  1/61 (1.64%) 
Urinary tract infection   0/61 (0.00%)  1/61 (1.64%) 
Viral upper respiratory tract infection   1/61 (1.64%)  1/61 (1.64%) 
Injury, poisoning and procedural complications     
Concussion   1/61 (1.64%)  0/61 (0.00%) 
Facial bones fracture   1/61 (1.64%)  0/61 (0.00%) 
Foot fracture   1/61 (1.64%)  0/61 (0.00%) 
Contusion   1/61 (1.64%)  0/61 (0.00%) 
Investigations     
Haemeoglobin decreased   1/61 (1.64%)  0/61 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain   1/61 (1.64%)  1/61 (1.64%) 
Pain in extremity   0/61 (0.00%)  1/61 (1.64%) 
Nervous system disorders     
Burning Sensation   0/61 (0.00%)  1/61 (1.64%) 
Headache   3/61 (4.92%)  3/61 (4.92%) 
Reproductive system and breast disorders     
Uterine cyst   1/61 (1.64%)  0/61 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis   1/61 (1.64%)  0/61 (0.00%) 
Dermatitis atopic   0/61 (0.00%)  2/61 (3.28%) 
Dermatitis contact   2/61 (3.28%)  1/61 (1.64%) 
Pruritus   0/61 (0.00%)  2/61 (3.28%) 
Rosacea   0/61 (0.00%)  1/61 (1.64%) 
Urticaria   1/61 (1.64%)  0/61 (0.00%) 
Vascular disorders     
Arteriosclerosis   1/61 (1.64%)  0/61 (0.00%) 
Hypertension   0/61 (0.00%)  1/61 (1.64%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor shall have 45 days to review the papers. Sponsor shall have the right to require Institution/Principal Investigator, as applicable, to remove specifically identified confidential information and/or delay the proposed publication or presentation for an additional one hundred twenty (120) days to enable Sponsor to seek patent protections.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hyun Kim, Vice President Clinical Operations
Organization: AOBiome Therapeutics
Phone: 617-639-9980
EMail: hkim@aobiome.com
Layout table for additonal information
Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT03235024    
Other Study ID Numbers: ADB244-001
First Submitted: July 20, 2017
First Posted: August 1, 2017
Results First Submitted: July 19, 2022
Results First Posted: October 10, 2022
Last Update Posted: October 10, 2022