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CompletedNCT04490109Updated Jan 28, 2025Results posted

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

A Phase 2 interventional study of B244 and Vehicle in Atopic Dermatitis and Pruritus, sponsored by AOBiome LLC. Completed at 56 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-28.

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

Phase
Phase 2
Study type
Interventional
Enrollment
547
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Atopic Dermatitis
  • Pruritus
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

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

Study arms

  • Experimental
    B244 Suspension O.D. 5.0

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

    Biological: B244

  • Experimental
    B244 Suspension O.D. 20.0

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

    Biological: B244

  • Placebo comparator
    Placebo

    Third arm of 192 subjects will receive a vehicle dosing.

    Biological: Vehicle

Interventions

  • BiologicalB244

    B244 suspension

  • BiologicalVehicle

    Vehicle suspension

05

What researchers measure

Primary outcomes

  1. Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Time frame: Baseline to Day 28

Secondary outcomes

  1. Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Time frame: Baseline to Day 28

  2. Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Time frame: Baseline to Day 28

  3. Mean Change in Average Itch Numeric Rating Scale (AI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

    Time frame: Baseline to Day 28

  4. Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

    Time frame: Baseline to Day 28

  5. Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

    Time frame: Baseline to Day 28

  6. Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Time frame: Baseline to Day 14

  7. Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

    The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

    Time frame: Baseline to Day 14

  8. Mean Change in Patient Oriented Eczema Measure (POEM)

    The Patient Oriented Eczema Measure (POEM) is a tool developed by the University of Nottingham, United Kingdom, for monitoring atopic dermatitis severity. The subject will complete the questionnaire at each of the assessment timepoints as outlined. Each of the 7 questions in the POEM questionnaire carries equal weight and is scored from 0 to 4: No days = 0. 1 to 2 days = 1. 3 to 4 days = 2. 5 to 6 days = 3. Every day = 4. Scores are then added to yield a total score of 0 to 28; higher scores mean the greater the severity of atopic dermatitis.

    Time frame: Baseline to Day 28

  9. Mean Change in 5-D Pruritus Scale

    The 5-D Pruritus Scale is a validated, multi-dimensional measure of itching that assesses the five domains of degree (score 1-5: 1=not present, 2=mild, 3=moderate, 4=severe, 5=unbearable), duration (score 1-5: 1=less than 6hrs/day, 2=6-12hrs/day, 3=12-18hrs/day, 4=18-23hrs/day, 5=all day), direction (score 1-5: 1=completely resolved, 2=much better/still present, 3=little bit better/still present, 4=unchanged, 5=getting worse), disability (score 1-5: 1=never affects activity, 2=rarely affects activity, 3=occasionally affects activity, 4=frequently affects activity, 5=always affects activity; highest activity score is taken), and distribution (check boxes of affected body parts; 0-2 body parts=score of 1, 3-5=score of 2, 6-10=score of 3, 11-13=score of 4, 14-16=score of 5). The domains are scored separately and then summed together to obtain a total 5-D score, ranging from 5 (no pruritus) to 25 (most severe pruritus). Subjects rate their symptoms over the preceding 2-week period.

    Time frame: Baseline to Day 28

Other outcomes

  1. Mean Change in Investigator's Global Assessment (IGA)

    Investigator's Global Assessment (IGA) 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

  2. Mean Change in Eczema Area Severity Index (EASI)

    Eczema Area Severity Index (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 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.

    Time frame: Baseline to Day 28

  3. Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement

    Investigator's Global Assessment (IGA) 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. Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4

    Investigator's Global Assessment (IGA) 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

  5. Proportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4

    Investigator's Global Assessment (IGA) 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

  6. Proportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50)

    Eczema Area Severity Index (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 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.

    Time frame: Baseline to Day 28

  7. Proportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75)

    Eczema Area Severity Index (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 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.

    Time frame: Baseline to Day 28

  8. Proportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90)

    Eczema Area Severity Index (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 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.

    Time frame: Baseline to Day 28

06

Results

Posted Dec 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneB244 O.D. 5.0B244 O.D. 20.0Vehicle
Started180180187
Treated180180186
Completed161155166
Not completed192521
Withdrew: Lost to follow-up3104
Withdrew: Withdrawal by subject869
Withdrew: Physician decision023
Withdrew: Adverse event210
Withdrew: Significant non-compliance244
Withdrew: Significant clinical event010
Withdrew: Other reason411

Outcome measures

PrimaryMean Change in Worst Itch Numeric Rating Scale (WI-NRS)

The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

Time frame:
Baseline to Day 28
Reported as:
Least squares mean · score on a scale
Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)
score on a scaleB244 O.D. 5.0B244 O.D. 20.0Vehicle
Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)-2.8 ± 0.184-2.8 ± 0.184-2.1 ± 0.180
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · ANCOVA · p = 0.0148
  • B244 O.D. 20.0 vs Vehicle · ANCOVA · p = 0.0143
SecondaryProportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)515138
SecondaryProportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS)
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS)120115105
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Regression, Logistic · p = 0.0205
SecondaryMean Change in Average Itch Numeric Rating Scale (AI-NRS)

The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

Time frame:
Baseline to Day 28
Reported as:
Least squares mean · score on a scale
Mean Change in Average Itch Numeric Rating Scale (AI-NRS)
score on a scaleB244 O.D. 5.0B244 O.D. 20.0Vehicle
Mean Change in Average Itch Numeric Rating Scale (AI-NRS)-2.7 ± .132-2.7 ± .132-2.1 ± .164
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Mixed Models Analysis · p = 0.0044
  • B244 O.D. 20.0 vs Vehicle · Mixed Models Analysis · p = 0.0077
SecondaryProportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS)

The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS)
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS)545339
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Regression, Logistic · p = 0.0400
  • B244 O.D. 20.0 vs Vehicle · Regression, Logistic · p = 0.0486
SecondaryProportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS)

The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."

Time frame:
Baseline to Day 28
Reported as:
Count of participants · Participants
Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS)
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS)118112110
SecondaryMean Change in Worst Itch Numeric Rating Scale (WI-NRS)

The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

Time frame:
Baseline to Day 14
Reported as:
Least squares mean · score on a scale
Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)
score on a scaleB244 O.D. 5.0B244 O.D. 20.0Vehicle
Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)-2.0 ± .138-2.0 ± .137-1.5 ± .170
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Mixed Models Analysis · p = 0.0246
  • B244 O.D. 20.0 vs Vehicle · Mixed Models Analysis · p = 0.0366
SecondaryProportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)

The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."

Time frame:
Baseline to Day 14
Reported as:
Count of participants · Participants
Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)343021
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Regression, Logistic · p = 0.0467
SecondaryMean Change in Patient Oriented Eczema Measure (POEM)

The Patient Oriented Eczema Measure (POEM) is a tool developed by the University of Nottingham, United Kingdom, for monitoring atopic dermatitis severity. The subject will complete the questionnaire at each of the assessment timepoints as outlined. Each of the 7 questions in the POEM questionnaire carries equal weight and is scored from 0 to 4: No days = 0. 1 to 2 days = 1. 3 to 4 days = 2. 5 to 6 days = 3. Every day = 4. Scores are then added to yield a total score of 0 to 28; higher scores mean the greater the severity of atopic dermatitis.

Time frame:
Baseline to Day 28
Reported as:
Least squares mean · score on a scale
Mean Change in Patient Oriented Eczema Measure (POEM)
score on a scaleB244 O.D. 5.0B244 O.D. 20.0Vehicle
Mean Change in Patient Oriented Eczema Measure (POEM)-6.4 ± .342-6.0 ± .343-5.2 ± .394
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Mixed Models Analysis · p = 0.0293
SecondaryMean Change in 5-D Pruritus Scale

The 5-D Pruritus Scale is a validated, multi-dimensional measure of itching that assesses the five domains of degree (score 1-5: 1=not present, 2=mild, 3=moderate, 4=severe, 5=unbearable), duration (score 1-5: 1=less than 6hrs/day, 2=6-12hrs/day, 3=12-18hrs/day, 4=18-23hrs/day, 5=all day), direction (score 1-5: 1=completely resolved, 2=much better/still present, 3=little bit better/still present, 4=unchanged, 5=getting worse), disability (score 1-5: 1=never affects activity, 2=rarely affects activity, 3=occasionally affects activity, 4=frequently affects activity, 5=always affects activity; highest activity score is taken), and distribution (check boxes of affected body parts; 0-2 body parts=score of 1, 3-5=score of 2, 6-10=score of 3, 11-13=score of 4, 14-16=score of 5). The domains are scored separately and then summed together to obtain a total 5-D score, ranging from 5 (no pruritus) to 25 (most severe pruritus). Subjects rate their symptoms over the preceding 2-week period.

Time frame:
Baseline to Day 28
Reported as:
Least squares mean · score on a scale
Mean Change in 5-D Pruritus Scale
score on a scaleB244 O.D. 5.0B244 O.D. 20.0Vehicle
Mean Change in 5-D Pruritus Scale-5.2 ± .228-5.2 ± .229-4.2 ± .262
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Mixed Models Analysis · p = 0.0045
  • B244 O.D. 20.0 vs Vehicle · Mixed Models Analysis · p = 0.0043
Other pre-specifiedMean Change in Investigator's Global Assessment (IGA)

Investigator's Global Assessment (IGA) 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:
Least squares mean · score on a scale
Mean Change in Investigator's Global Assessment (IGA)
score on a scaleB244 O.D. 5.0B244 O.D. 20.0Vehicle
Mean Change in Investigator's Global Assessment (IGA)-0.8 ± .056-0.8 ± .056-0.5 ± .064
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Mixed Models Analysis · p = 0.0026
  • B244 O.D. 20.0 vs Vehicle · Mixed Models Analysis · p = 0.0005
Other pre-specifiedMean Change in Eczema Area Severity Index (EASI)

Eczema Area Severity Index (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 0.0 to 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:
Least squares mean · score on a scale
Mean Change in Eczema Area Severity Index (EASI)
score on a scaleB244 O.D. 5.0B244 O.D. 20.0Vehicle
Mean Change in Eczema Area Severity Index (EASI)-3.9 ± .249-4.0 ± .250-3.1 ± .289
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Mixed Models Analysis · p = 0.0348
  • B244 O.D. 20.0 vs Vehicle · Mixed Models Analysis · p = 0.0173
Other pre-specifiedProportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement

Investigator's Global Assessment (IGA) 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:
Count of participants · Participants
Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement364321
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Regression, Logistic · p = 0.0228
  • B244 O.D. 20.0 vs Vehicle · Regression, Logistic · p = 0.0015
Other pre-specifiedProportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4

Investigator's Global Assessment (IGA) 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:
Count of participants · Participants
Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4466234
Statistical analysis
  • B244 O.D. 20.0 vs Vehicle · Regression, Logistic · p = 0.0003
Other pre-specifiedProportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4

Investigator's Global Assessment (IGA) 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:
Count of participants · Participants
Proportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4819173
Statistical analysis
  • B244 O.D. 20.0 vs Vehicle · Regression, Logistic · p = 0.0195
Other pre-specifiedProportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50)

Eczema Area Severity Index (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 0.0 to 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:
Count of participants · Participants
Proportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50)
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50)747660
Statistical analysis
  • B244 O.D. 20.0 vs Vehicle · Regression, Logistic · p = 0.0365
Other pre-specifiedProportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75)

Eczema Area Severity Index (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 0.0 to 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:
Count of participants · Participants
Proportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75)
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75)464827
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Regression, Logistic · p = 0.0086
  • B244 O.D. 20.0 vs Vehicle · Regression, Logistic · p = 0.0035
Other pre-specifiedProportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90)

Eczema Area Severity Index (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 0.0 to 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:
Count of participants · Participants
Proportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90)
ParticipantsB244 O.D. 5.0B244 O.D. 20.0Vehicle
Proportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90)253010
Statistical analysis
  • B244 O.D. 5.0 vs Vehicle · Regression, Logistic · p = 0.0074
  • B244 O.D. 20.0 vs Vehicle · Regression, Logistic · p = 0.0008

Adverse events

Collected over Screening visit to Week 8.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
B244 O.D. 5.00/180 (0%)0/180 (0%)33/180 (18.3%)
B244 O.D. 20.00/180 (0%)0/180 (0%)29/180 (16.1%)
Vehicle0/186 (0%)0/186 (0%)17/186 (9.1%)
Most frequent other events
Showing 10 of 48
Most frequent other events
EventB244 O.D. 5.0B244 O.D. 20.0Vehicle
HeadacheNervous system disorders6/1804/1801/186
ArthralgiaMusculoskeletal and connective tissue disorders1/1804/1800/186
Application site pruritusGeneral disorders3/1800/1800/186
Vaccination site discomfortGeneral disorders3/1800/1801/186
COVID-19Infections and infestations2/1803/1801/186
Back painMusculoskeletal and connective tissue disorders1/1803/1802/186
Abdominal pain upperGastrointestinal disorders0/1802/1800/186
DyspepsiaGastrointestinal disorders2/1800/1800/186
Application site erythemaGeneral disorders2/1800/1800/186
Gastroenteritis viralInfections and infestations0/1802/1800/186

Baseline characteristics

Population includes patients from the Modified Intent-to-Treat (mITT) population, including all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Baseline measures collected include all measures that were collected under the study protocol.

Age, Continuous
Age, Continuous(years)B244 O.D. 5.0B244 O.D. 20.0VehicleTotal
Mean42.2 ± 12.9342.1 ± 13.4942.1 ± 13.1542.1 ± 13.17
Age, Customized
Age, Customized(Participants)B244 O.D. 5.0B244 O.D. 20.0VehicleTotal
18 to 40 years788074232
41 to 54 years575264173
55 to 65 years374039116
Sex: Female, Male
Sex: Female, Male(Participants)B244 O.D. 5.0B244 O.D. 20.0VehicleTotal
Female118111122351
Male546155170
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)B244 O.D. 5.0B244 O.D. 20.0VehicleTotal
Hispanic or Latino878885260
Not Hispanic or Latino858492261
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)B244 O.D. 5.0B244 O.D. 20.0VehicleTotal
American Indian or Alaska Native0000
Asian19182158
Native Hawaiian or Other Pacific Islander0011
Black or African American364139116
White113111114338
More than one race0000
Unknown or Not Reported4228
Height
Height(centimeters)B244 O.D. 5.0B244 O.D. 20.0VehicleTotal
Mean166.100 ± 9.706165.608 ± 9.923166.102 ± 8.836165.938 ± 9.479
Weight
Weight(kilograms)B244 O.D. 5.0B244 O.D. 20.0VehicleTotal
Mean84.144 ± 22.10481.351 ± 19.60381.908 ± 20.65382.462 ± 20.805
Body Mass Index (BMI)
Body Mass Index (BMI)(kilograms/meters^2)B244 O.D. 5.0B244 O.D. 20.0VehicleTotal
Mean30.576 ± 8.11229.610 ± 6.57729.729 ± 7.40329.969 ± 7.389

13 further baseline measures are reported on the registry.

07

Study locations

56 sites
  • Cahaba Dermatology
    Birmingham, Alabama 35244, United States
  • Elite Clinical Studies, LLC
    Phoenix, Arizona 85018, United States
  • Cognitive Clinical Trials
    Scottsdale, Arizona 85260, United States
  • Dermatology Trial Associates
    Bryant, Arkansas 72022, United States
  • Applied Research Center of Arkansas, Inc
    Little Rock, Arkansas 72212, United States
  • Core Healthcare Group
    Cerritos, California 90703, United States
  • Encino Research Center
    Encino, California 91436, United States
  • Center for Dermatology, INC
    Fremont, California 94538, United States
  • Antelope Valley Clinical Trials
    Lancaster, California 93534, United States
  • Long Beach Clinical Trials Services
    Long Beach, California 90806, United States
  • L.A. Universal Research Center Inc
    Los Angeles, California 90057, United States
  • Providence Clinical Research
    North Hollywood, California 91606, United States
  • Syrentis Clinical Research
    Santa Ana, California 92705, United States
  • IMMUNOe Research Centers
    Centennial, Colorado 80112, United States
  • Tampa Bay Medical Research
    Clearwater, Florida 33761, United States
  • Palm Beach Dermatology Group
    Delray Beach, Florida 33484, United States
  • Meridian International Research
    Miami Gardens, Florida 33014, United States
  • South Coast Research Center, Inc
    Miami, Florida 33136, United States
  • D&H National Research Center
    Miami, Florida 33155, United States
  • NAPA Research
    Pompano Beach, Florida 33064, United States
  • Clinical Research Trials of Florida, Inc
    Tampa, Florida 33607, United States
  • Moore Clinical Research
    Tampa, Florida 33609, United States
  • Medical Dermatology Associates of Chicago
    Chicago, Illinois 60654, United States
  • Clinical Investigation Specialists
    Libertyville, Illinois 60048, United States
  • Sneeze Wheeze & Itch Associates, LLC
    Normal, Illinois 61761, United States
  • Epiphany Dermatology
    Overland Park, Kansas 66215, United States
  • Meridian Clinical Research
    Baton Rouge, Louisiana 70808, United States
  • Continental Clinical Solutions
    Towson, Maryland 21204, United States
  • Oakland Hills Dermatology
    Auburn Hills, Michigan 48326, United States
  • Clarkston Dermatology
    Clarkston, Michigan 48346, United States
  • Onyx Clinical Reserach
    Flint, Michigan 48507, United States
  • mediSearch Clinical Trials
    Saint Joseph, Missouri 64506, United States
  • Thomas Dermatology
    Henderson, Nevada 89052, United States
  • JDR Dermatology Research, LLC
    Las Vegas, Nevada 89148, United States
  • ActivMed Practices & Research
    Portsmouth, New Hampshire 03801, United States
  • The Dermatology Group, P. C.
    Verona, New Jersey 07044, United States
  • Drug Trials Brooklyn
    Brooklyn, New York 11230, United States
  • Drug Trials America
    Hartsdale, New York 10530, United States
  • Saddick Research Group
    New York, New York 10075, United States
  • Dermatology Consulting Services, LLC
    High Point, North Carolina 27262, United States
  • Wake Research
    Raleigh, North Carolina 27612, United States
  • Clinical Research Solutions
    Cleveland, Ohio 44130, United States
  • Unity Clinical Research
    Oklahoma City, Oklahoma 73118, United States
  • Velocity Clinical Research
    Medford, Oregon 97504, United States
  • Dermdox Centers for Dematology
    Sugarloaf, Pennsylvania 18249, United States
  • Peak Research LLC
    Upper Saint Clair, Pennsylvania 15241, United States
  • Greater Providence Clinical Research
    Cranston, Rhode Island 02920, United States
  • AAPRI Research
    Warwick, Rhode Island 02886, United States
  • Omega Medical Research
    Warwick, Rhode Island 02886, United States
  • Dermatology & Laser Center of Charleston
    Charleston, South Carolina 29407, United States
  • Peak Research LLC
    Fort Mill, South Carolina 29708, United States
  • Clinical Research Solutions
    Milan, Tennessee 38358, United States
  • ACRC Trials
    Plano, Texas 75024, United States
  • Aspen Dermatology
    Orem, Utah 84058, United States
  • Advance Clinical Research
    Salt Lake City, Utah 84117, United States
  • Dominion Medical Associates
    Richmond, Virginia 23219, United States
08

References and documents

Study documents

  • Study protocol · Feb 28, 2020
  • Statistical analysis plan · Jan 12, 2022

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
NCT04490109
Lead sponsor
AOBiome LLC
Collaborators
bioRASI, LLC
Responsible party
Sponsor
First posted
Jul 28, 2020
Start date
Jun 24, 2020
Primary completion
Dec 10, 2021
Completion
Jan 7, 2022
Results posted
Dec 19, 2024
Last update
Jan 28, 2025

Study contacts

Hyun Kim, PhD
study director · AOBiome LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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