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B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
B244
Vehicle
Sponsored by
AOBiome LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female subjects 18 to 65 years of age.
  2. Pruritus of at least 4 weeks duration prior to the initial Screening visit and during the 2 week washout period.

    a. Subjects using stable doses of oral H1 antihistamines at the initial Screening visit must be willing to continue these at the same doses and frequencies throughout the study inclusive of the follow-up period.

  3. Worst Itch Numeric Rating Scale (WI-NRS) score ≥ 7 in the 24-hour period prior to the initial Screening as well as Baseline visits.
  4. Average weekly WI-NRS score ≥6 for each week of the washout period, as recorded in the eDiary.
  5. A history of atopic dermatitis for greater than 12 months consistent with a diagnosis of atopic dermatitis, as defined by the 2014 American Academy of Dermatology (AAD) Guidelines of Care for the Management of Atopic Dermatitis.

    1. Subjects using bland emollients at the initial Screening visit will be allowed to continue to use their emollient of choice at the same dose and frequency throughout the study.
    2. Subjects using low- to mid-potency topical corticosteroids at the initial Screening visit will be allowed to use their topical corticosteroid of choice at the same dose and frequency no more than 7 days per month throughout the study as rescue medication.
  6. A minimum of 10% and not more than 40% 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) at Screening and Baseline.

    a. Subjects' BSA can include face and body OR body alone BUT NOT face alone.

  7. An Investigator Global Assessment (IGA) score of 2-3 at Screening and Baseline.
  8. Willing and able to complete once-daily eDiary entries within a consistent timeframe for the duration of the study and have ≥80% eDiary compliance rate during the washout period.
  9. Judged to be in good health in the investigator's opinion.,

Exclusion Criteria:

  1. Clearly defined etiology for pruritus other than atopic dermatitis. These include but are not limited to urticaria, psoriasis or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, untreated hyperthyroidism, parasite presence and presence of acute infection either systemically or in the AD lesions.
  2. Presence of any acute condition which may risk inducing an atopic dermatitis flare during the course of the study, such as impetigo or active herpes simplex infection.
  3. Treatment with systemic corticosteroids within 4 weeks prior to randomization.
  4. Treatment with Class III or higher potency topical corticosteroids or any topical anti-pruritic therapies (other than stable doses of low- or mid-potency topical corticosteroids or bland emollients) within 4 weeks prior to randomization.
  5. Treatment with systemic therapies with recognized anti-pruritic (e.g. tricyclic antidepressants, sedatives, tranquilizers, gabapentin, marijuana or other cannabinoids, opioid receptor agonists/antagonists) or pruritic (e.g. opioids, angiotensin-converting enzyme inhibitors, cocaine,,antimalarials) properties within 4 weeks prior to randomization.

    a. Stable doses of H1 antihistamines will be permitted. Subjects must be willing to continue these at the same doses and frequencies throughout the study inclusive of the follow-up period.

  6. Any clinically significant changes in type, dose, or frequency of bland emollients, low- or mid-potency corticosteroids, and/or oral H1 antihistamines throughout the study from screening to follow-up.
  7. Treatment with systemic immunosuppressive/ immunomodulatory therapies within 4 weeks prior to randomization (including but not limited to phosphodiesterase-4 inhibitors, cyclosporine, mycophenolate-mofetil, methotrexate, azathioprine, interferon-gamma, or phototherapy).
  8. Treatment with biologic therapies within 12 weeks or 5 half-lives prior to randomization, whichever is longer.
  9. Use of an indoor tanning facility within 4 weeks prior to randomization.
  10. Treatment with any investigational therapy within 4 weeks prior to randomization.
  11. Allergen immunotherapy within 6 months prior to randomization.
  12. Prior use of AO+ Mist.
  13. History of malignancy within 5 years prior to randomization, with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
  14. History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt.
  15. Known active hepatitis infection.
  16. Known history of human immunodeficiency virus (HIV) infection.
  17. Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
  18. Currently pregnant or breastfeeding, or male subject with a pregnant or breastfeeding partner.
  19. Females of childbearing potential who are unable or unwilling to practice highly effective contraception (pregnancy prevention); fertile males who are unable or unwilling to use condoms with female partners of childbearing potential.

Sites / Locations

  • Cahaba Dermatology
  • Elite Clinical Studies, LLC
  • Cognitive Clinical Trials
  • Dermatology Trial Associates
  • Applied Research Center of Arkansas, Inc
  • Core Healthcare Group
  • Encino Research Center
  • Center for Dermatology, INC
  • Antelope Valley Clinical Trials
  • Long Beach Clinical Trials Services
  • L.A. Universal Research Center Inc
  • Providence Clinical Research
  • Syrentis Clinical Research
  • IMMUNOe Research Centers
  • Tampa Bay Medical Research
  • Meridian International Research
  • South Coast Research Center, Inc
  • D&H National Research Center
  • NAPA Research
  • Clinical Research Trials of Florida, Inc
  • Moore Clinical Research
  • Sneeze Wheeze & Itch Associates, LLC
  • Epiphany Dermatology
  • Meridian Clinical Research
  • Continental Clinical Solutions
  • Oakland Hills Dermatology
  • Clarkston Dermatology
  • Onyx Clinical Reserach
  • mediSearch Clinical Trials
  • JDR Dermatology Research, LLC
  • ActivMed Practices & Research
  • The Dermatology Group, P. C.
  • Drug Trials Brooklyn
  • Drug Trials America
  • Saddick Research Group
  • Dermatology Consulting Services, LLC
  • Wake Research
  • Clinical Research Solutions
  • Unity Clinical Research
  • Crisor LLC C/O Clinical Research Institute of Southern Oregon, Inc
  • Dermdox Centers for Dematology
  • Peak Research LLC
  • Greater Providence Clinical Research
  • AAPRI Research
  • Omega Medical Research
  • Dermatology & Laser Center of Charleston
  • Clinical Research Solutions
  • ACRC Trials
  • Aspen Dermatology
  • Advance Clinical Research
  • Dominion Medical Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

B244 Suspension O.D. 5.0

B244 Suspension O.D. 20.0

Placebo

Arm Description

One arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension

Second arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension

Third arm of 192 subjects will receive a vehicle dosing.

Outcomes

Primary Outcome Measures

Mean change in WI-NRS from baseline to Week 4
Assessing the efficacy of B244 by measuring the mean change in WI-NRS reported by subjects from baseline to Week 4

Secondary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Assessing the safety and tolerability of B244 by monitoring the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Full Information

First Posted
July 16, 2020
Last Updated
October 7, 2022
Sponsor
AOBiome LLC
Collaborators
bioRASI, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04490109
Brief Title
B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis
Official Title
A Phase II, Randomized, Double-Blind, Vehicle Controlled Study of the Efficacy, Safety, and Tolerability of B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
January 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AOBiome LLC
Collaborators
bioRASI, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety, and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of atopic dermatitis. Subjects who meet the study entry criteria will be randomized in a 1:1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0, B244 O.D. 20.0, or vehicle (placebo) for 4 weeks.
Detailed Description
This is a Prospective, Vehicle Controlled, Double-Blind, Multicenter, Randomized Phase II Trial, comparing the effect of twice daily B244 applications for 4 weeks vs vehicle applications on treatment of mild to moderate pruritus associated with atopic dermatitis. Approximately 576 subjects may be enrolled. The total duration of the study will be approximately 11 weeks. Participants will report for a Screening visit and if all inclusion/exclusion criteria are met, subjects will go through a two-week washout phase before reporting for a Baseline visit. After screening and baseline, participants will be randomized to one of two doses of B244 or vehicle application for 4 weeks. Randomization will be 1:1:1 so that an equal number of patients will be treated in each Arm of the study. All B244 randomized subjects will be treated at the dose of O.D. 5.0 or O.D. 20.0 Subjects must be willing and able to complete diary within a consistent time frame on a daily basis and to comply with restrictions on allowable therapies for the duration of the study. All subjects will attend a screening visit not more than 21 days prior to Baseline (Day 0). Subjects will be required to return to the clinic at Baseline, Day 14 (Week 2) and Day 28 (Week 4) visits. All subjects will be asked to attend a Week 8 follow-up visit 4 weeks (28 (±3) days) after the last dose of study medication. Subjects will apply a total of 10 pumps of IP per application across all affected areas twice-a-day (i.e. 10 pumps in the morning and 10 pumps again at night) for 4 weeks. Safety evaluations will consist of review of participant's medical history at screening and on-going assessment of adverse events reported throughout the study duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind, randomized, vehicle-controlled, randomized in a 1:1:1 ratio
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B244 Suspension O.D. 5.0
Arm Type
Experimental
Arm Description
One arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension
Arm Title
B244 Suspension O.D. 20.0
Arm Type
Experimental
Arm Description
Second arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Third arm of 192 subjects will receive a vehicle dosing.
Intervention Type
Biological
Intervention Name(s)
B244
Intervention Description
B244 suspension
Intervention Type
Biological
Intervention Name(s)
Vehicle
Intervention Description
Vehicle suspension
Primary Outcome Measure Information:
Title
Mean change in WI-NRS from baseline to Week 4
Description
Assessing the efficacy of B244 by measuring the mean change in WI-NRS reported by subjects from baseline to Week 4
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Description
Assessing the safety and tolerability of B244 by monitoring the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects 18 to 65 years of age. Pruritus of at least 4 weeks duration prior to the initial Screening visit and during the 2 week washout period. a. Subjects using stable doses of oral H1 antihistamines at the initial Screening visit must be willing to continue these at the same doses and frequencies throughout the study inclusive of the follow-up period. Worst Itch Numeric Rating Scale (WI-NRS) score ≥ 7 in the 24-hour period prior to the initial Screening as well as Baseline visits. Average weekly WI-NRS score ≥6 for each week of the washout period, as recorded in the eDiary. A history of atopic dermatitis for greater than 12 months consistent with a diagnosis of atopic dermatitis, as defined by the 2014 American Academy of Dermatology (AAD) Guidelines of Care for the Management of Atopic Dermatitis. Subjects using bland emollients at the initial Screening visit will be allowed to continue to use their emollient of choice at the same dose and frequency throughout the study. Subjects using low- to mid-potency topical corticosteroids at the initial Screening visit will be allowed to use their topical corticosteroid of choice at the same dose and frequency no more than 7 days per month throughout the study as rescue medication. A minimum of 10% and not more than 40% 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) at Screening and Baseline. a. Subjects' BSA can include face and body OR body alone BUT NOT face alone. An Investigator Global Assessment (IGA) score of 2-3 at Screening and Baseline. Willing and able to complete once-daily eDiary entries within a consistent timeframe for the duration of the study and have ≥80% eDiary compliance rate during the washout period. Judged to be in good health in the investigator's opinion., Exclusion Criteria: Clearly defined etiology for pruritus other than atopic dermatitis. These include but are not limited to urticaria, psoriasis or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, untreated hyperthyroidism, parasite presence and presence of acute infection either systemically or in the AD lesions. Presence of any acute condition which may risk inducing an atopic dermatitis flare during the course of the study, such as impetigo or active herpes simplex infection. Treatment with systemic corticosteroids within 4 weeks prior to randomization. Treatment with Class III or higher potency topical corticosteroids or any topical anti-pruritic therapies (other than stable doses of low- or mid-potency topical corticosteroids or bland emollients) within 4 weeks prior to randomization. Treatment with systemic therapies with recognized anti-pruritic (e.g. tricyclic antidepressants, sedatives, tranquilizers, gabapentin, marijuana or other cannabinoids, opioid receptor agonists/antagonists) or pruritic (e.g. opioids, angiotensin-converting enzyme inhibitors, cocaine,,antimalarials) properties within 4 weeks prior to randomization. a. Stable doses of H1 antihistamines will be permitted. Subjects must be willing to continue these at the same doses and frequencies throughout the study inclusive of the follow-up period. Any clinically significant changes in type, dose, or frequency of bland emollients, low- or mid-potency corticosteroids, and/or oral H1 antihistamines throughout the study from screening to follow-up. Treatment with systemic immunosuppressive/ immunomodulatory therapies within 4 weeks prior to randomization (including but not limited to phosphodiesterase-4 inhibitors, cyclosporine, mycophenolate-mofetil, methotrexate, azathioprine, interferon-gamma, or phototherapy). Treatment with biologic therapies within 12 weeks or 5 half-lives prior to randomization, whichever is longer. Use of an indoor tanning facility within 4 weeks prior to randomization. Treatment with any investigational therapy within 4 weeks prior to randomization. Allergen immunotherapy within 6 months prior to randomization. Prior use of AO+ Mist. History of malignancy within 5 years prior to randomization, with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin. History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt. Known active hepatitis infection. Known history of human immunodeficiency virus (HIV) infection. Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject. Currently pregnant or breastfeeding, or male subject with a pregnant or breastfeeding partner. Females of childbearing potential who are unable or unwilling to practice highly effective contraception (pregnancy prevention); fertile males who are unable or unwilling to use condoms with female partners of childbearing potential.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Kim, PhD
Organizational Affiliation
AOBiome LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Dermatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Cognitive Clinical Trials
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Dermatology Trial Associates
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Applied Research Center of Arkansas, Inc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Core Healthcare Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Center for Dermatology, INC
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Antelope Valley Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Long Beach Clinical Trials Services
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
L.A. Universal Research Center Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Meridian International Research
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
South Coast Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
D&H National Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
NAPA Research
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Moore Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Sneeze Wheeze & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Epiphany Dermatology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Meridian Clinical Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Continental Clinical Solutions
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Oakland Hills Dermatology
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
Clarkston Dermatology
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Onyx Clinical Reserach
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
mediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
JDR Dermatology Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
ActivMed Practices & Research
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
The Dermatology Group, P. C.
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Drug Trials Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Saddick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Dermatology Consulting Services, LLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Clinical Research Solutions
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Unity Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Crisor LLC C/O Clinical Research Institute of Southern Oregon, Inc
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Dermdox Centers for Dematology
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Facility Name
Peak Research LLC
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Greater Providence Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
AAPRI Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Dermatology & Laser Center of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Clinical Research Solutions
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
ACRC Trials
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Aspen Dermatology
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Advance Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Dominion Medical Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis

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