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| Name | Class |
|---|---|
| bioRASI, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B244 Suspension O.D. 5.0 | Experimental | One arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension |
|
| B244 Suspension O.D. 20.0 | Experimental | Second arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension |
|
| Placebo | Placebo Comparator | Third arm of 192 subjects will receive a vehicle dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B244 | Biological | B244 suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Day 28 |
| Mean Change in Eczema Area Severity Index (EASI) |
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Kim, PhD | AOBiome LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology | Birmingham | Alabama | 35244 | United States | ||
| Elite Clinical Studies, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37396805 | Derived | Silverberg JI, Lio PA, Simpson EL, Li C, Brownell DR, Gryllos I, Ng-Cashin J, Krueger T, Swaidan VR, Bliss RL, Kim HD. Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: a randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial. EClinicalMedicine. 2023 May 16;60:102002. doi: 10.1016/j.eclinm.2023.102002. eCollection 2023 Jun. |
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| ID | Title | Description |
|---|---|---|
| FG000 | B244 O.D. 5.0 | B244 suspension (1x10E10 cells/ml) in 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension |
| FG001 | B244 O.D. 20.0 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2020 | Oct 3, 2024 |
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Double-blind, randomized, vehicle-controlled, randomized in a 1:1:1 ratio
| Vehicle |
| Biological |
Vehicle suspension |
|
| Baseline to Day 28 |
| 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." | Baseline to Day 28 |
| 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." | Baseline to Day 28 |
| 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." | Baseline to Day 28 |
| 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." | Baseline to Day 28 |
| 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." | Baseline to Day 14 |
| 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." | Baseline to Day 14 |
| 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. | Baseline to Day 28 |
| 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. | Baseline to Day 28 |
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. |
| Baseline to Day 28 |
| 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). | Baseline to Day 28 |
| 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). | Baseline to Day 28 |
| 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). | Baseline to Day 28 |
| 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. | Baseline to Day 28 |
| 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. | Baseline to Day 28 |
| 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. | Baseline to Day 28 |
| 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 |
| South Coast Research Center, Inc | Miami | Florida | 33136 | United States |
| D&H National Research Center | Miami | Florida | 33155 | United States |
| Meridian International Research | Miami Gardens | Florida | 33014 | 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 |
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
| FG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | B244 O.D. 5.0 | B244 suspension (1x10E10 cells/ml) in 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension |
| BG001 | B244 O.D. 20.0 | B244 suspension (4x10E10 cells/ml) in 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension |
| BG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Height | Mean | Standard Deviation | centimeters |
| ||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| ||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms/meters^2 |
| ||||||||||
| Body Surface Area (BSA) | Count of Participants | Participants |
| |||||||||||
| Body Surface Area (BSA) | Mean | Standard Deviation | percentage of body surface |
| ||||||||||
| Smoking Status | Count of Participants | Participants |
| |||||||||||
| Rescue Medication | Count of Participants | Participants |
| |||||||||||
| Rescue Medication Days | The population analyzed in this row represents only the participants who used a rescue medication. | Mean | Standard Deviation | days |
| |||||||||
| 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." | Mean | Standard Deviation | score on a scale |
| |||||||||
| 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." | Mean | Standard Deviation | score on a scale |
| |||||||||
| 5-D Pruritus Scale Total Score | The 5-D Pruritus Scale is a validated, multi-dimensional measure of itching that assesses the five domains of degree, duration, direction, disability, and distribution. 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). | Mean | Standard Deviation | score on a scale |
| |||||||||
| 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 and area of 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. | Count of Participants | Participants |
| ||||||||||
| Eczema Area Severity Index (EASI) Total Score | 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 and area of 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. | Mean | Standard Deviation | score on a scale |
| |||||||||
| 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). | Count of Participants | Participants |
| ||||||||||
| 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). | Mean | Standard Deviation | score on a scale |
| |||||||||
| Patient Oriented Eczema Measure (POEM) Total Score | 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. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 28 |
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| Secondary | 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." | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28. | Posted | Count of Participants | Participants | Baseline to Day 28 |
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| Secondary | 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." | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
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| Secondary | 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." | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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." | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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." | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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." | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 14 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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." | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 14 | Posted | Count of Participants | Participants | Baseline to Day 14 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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). | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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). | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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). | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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). | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28 | Posted | Count of Participants | Participants | Baseline to Day 28 |
|
Screening visit to Week 8.
All adverse events (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. AEs believed to be possibly related to IP must have been followed until their resolution.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B244 O.D. 5.0 | B244 suspension (1x10E10 cells/ml) in 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension | 0 | 180 | 0 | 180 | 33 | 180 |
| EG001 | B244 O.D. 20.0 | B244 suspension (4x10E10 cells/ml) in 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension | 0 | 180 | 0 | 180 | 29 | 180 |
| EG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension | 0 | 186 | 0 | 186 | 17 | 186 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Application site dryness | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vaccination site discomfort | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
Sponsor shall have 60 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 90 days to enable Sponsor to seek patent protections.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hyun Kim, Vice President Clinical Operations | AOBiome Therapeutics | 617-639-9980 | hkim@aobiome.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2022 | Nov 12, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
|
| 41 to 54 years |
|
|
| 55 to 65 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| >10 |
|
|
|
|
| Moderate |
|
|
| Severe |
|
|
|
|
| Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10. | ANCOVA | 0.0143 | Superiority | The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI. |
| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 |
| Vehicle |
Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| B244 O.D. 20.0 |
B244 suspension (4x10E10 cells/ml) in 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension |
| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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| OG002 | Vehicle | Vehicle, 30ml/bottle Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension |
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