Atopic Dermatitis, Pruritus
Conditions
Brief summary
This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety, and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of atopic dermatitis. Subjects who meet the study entry criteria will be randomized in a 1:1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0, B244 O.D. 20.0, or vehicle (placebo) for 4 weeks.
Detailed description
This is a Prospective, Vehicle Controlled, Double-Blind, Multicenter, Randomized Phase II Trial, comparing the effect of twice daily B244 applications for 4 weeks vs vehicle applications on treatment of mild to moderate pruritus associated with atopic dermatitis. * Approximately 576 subjects may be enrolled. * The total duration of the study will be approximately 11 weeks. Participants will report for a Screening visit and if all inclusion/exclusion criteria are met, subjects will go through a two-week washout phase before reporting for a Baseline visit. * After screening and baseline, participants will be randomized to one of two doses of B244 or vehicle application for 4 weeks. * Randomization will be 1:1:1 so that an equal number of patients will be treated in each Arm of the study. * All B244 randomized subjects will be treated at the dose of O.D. 5.0 or O.D. 20.0 * Subjects must be willing and able to complete diary within a consistent time frame on a daily basis and to comply with restrictions on allowable therapies for the duration of the study. * All subjects will attend a screening visit not more than 21 days prior to Baseline (Day 0). * Subjects will be required to return to the clinic at Baseline, Day 14 (Week 2) and Day 28 (Week 4) visits. All subjects will be asked to attend a Week 8 follow-up visit 4 weeks (28 (±3) days) after the last dose of study medication. * Subjects will apply a total of 10 pumps of IP per application across all affected areas twice-a-day (i.e. 10 pumps in the morning and 10 pumps again at night) for 4 weeks. * Safety evaluations will consist of review of participant's medical history at screening and on-going assessment of adverse events reported throughout the study duration.
Interventions
BIOLOGICALB244
B244 suspension
BIOLOGICALVehicle
Vehicle suspension
Sponsors
bioRASI, LLC
AOBiome LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind, randomized, vehicle-controlled, randomized in a 1:1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Worst Itch Numeric Rating Scale (WI-NRS) | Baseline to Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | Baseline to Day 28 | 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. |
| Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | Baseline to Day 28 | 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 Change in Average Itch Numeric Rating Scale (AI-NRS) | Baseline to Day 28 | 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. |
| Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS) | Baseline to Day 28 | 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. |
| Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS) | Baseline to Day 28 | 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 Change in Worst Itch Numeric Rating Scale (WI-NRS) | Baseline to Day 14 | 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. |
| Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | Baseline to Day 14 | 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 Change in Patient Oriented Eczema Measure (POEM) | Baseline to Day 28 | 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 Change in 5-D Pruritus Scale | Baseline to Day 28 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement | Baseline to Day 28 | 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). |
| Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4 | Baseline to Day 28 | 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). |
| Proportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4 | Baseline to Day 28 | 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). |
| Proportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50) | 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. |
| Proportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75) | 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. |
| Proportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90) | 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. |
| Mean Change in Eczema Area Severity Index (EASI) | 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. |
| Mean Change in Investigator's Global Assessment (IGA) | Baseline to Day 28 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 172 |
| 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 | 172 |
| 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 | 177 |
| Total | 521 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 10 | 4 |
| Overall Study | Other Reason | 4 | 1 | 1 |
| Overall Study | Physician Decision | 0 | 2 | 3 |
| Overall Study | Significant Clinical Event | 0 | 1 | 0 |
| Overall Study | Significant Non-Compliance | 2 | 4 | 4 |
| Overall Study | Withdrawal by Subject | 8 | 6 | 9 |
Baseline characteristics
| Characteristic | B244 O.D. 5.0 | Total | Vehicle | B244 O.D. 20.0 |
|---|---|---|---|---|
| 5-D Pruritus Scale Total Score | 17.0 score on a scale STANDARD_DEVIATION 2.59 | 16.9 score on a scale STANDARD_DEVIATION 2.79 | 17.0 score on a scale STANDARD_DEVIATION 2.89 | 16.6 score on a scale STANDARD_DEVIATION 2.86 |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 12.93 | 42.1 years STANDARD_DEVIATION 13.17 | 42.1 years STANDARD_DEVIATION 13.15 | 42.1 years STANDARD_DEVIATION 13.49 |
| Age, Customized 18 to 40 years | 78 Participants | 232 Participants | 74 Participants | 80 Participants |
| Age, Customized 41 to 54 years | 57 Participants | 173 Participants | 64 Participants | 52 Participants |
| Age, Customized 55 to 65 years | 37 Participants | 116 Participants | 39 Participants | 40 Participants |
| Average Itch Numeric Rating Scale (AI-NRS) | 7.53 score on a scale STANDARD_DEVIATION 1.062 | 7.45 score on a scale STANDARD_DEVIATION 1.268 | 7.39 score on a scale STANDARD_DEVIATION 1.374 | 7.42 score on a scale STANDARD_DEVIATION 1.344 |
| Body Mass Index (BMI) | 30.576 kilograms/meters^2 STANDARD_DEVIATION 8.112 | 29.969 kilograms/meters^2 STANDARD_DEVIATION 7.389 | 29.729 kilograms/meters^2 STANDARD_DEVIATION 7.403 | 29.610 kilograms/meters^2 STANDARD_DEVIATION 6.577 |
| Body Surface Area (BSA) 10-20% | 108 Participants | 339 Participants | 118 Participants | 113 Participants |
| Body Surface Area (BSA) >20-30% | 53 Participants | 157 Participants | 52 Participants | 52 Participants |
| Body Surface Area (BSA) >30-40% | 11 Participants | 25 Participants | 7 Participants | 7 Participants |
| Body Surface Area (BSA) | 18.82 percentage of body surface STANDARD_DEVIATION 7.247 | 18.30 percentage of body surface STANDARD_DEVIATION 6.653 | 18.08 percentage of body surface STANDARD_DEVIATION 6.6 | 18.02 percentage of body surface STANDARD_DEVIATION 6.069 |
| Eczema Area Severity Index (EASI) <=10 | 125 Participants | 363 Participants | 122 Participants | 116 Participants |
| Eczema Area Severity Index (EASI) >10 | 47 Participants | 158 Participants | 55 Participants | 56 Participants |
| Eczema Area Severity Index (EASI) Total Score | 9.23 score on a scale STANDARD_DEVIATION 5.463 | 9.04 score on a scale STANDARD_DEVIATION 4.797 | 8.92 score on a scale STANDARD_DEVIATION 4.56 | 8.98 score on a scale STANDARD_DEVIATION 4.321 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 87 Participants | 260 Participants | 85 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 261 Participants | 92 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 166.100 centimeters STANDARD_DEVIATION 9.706 | 165.938 centimeters STANDARD_DEVIATION 9.479 | 166.102 centimeters STANDARD_DEVIATION 8.836 | 165.608 centimeters STANDARD_DEVIATION 9.923 |
| Investigator's Global Assessment (IGA) Mild | 53 Participants | 154 Participants | 48 Participants | 53 Participants |
| Investigator's Global Assessment (IGA) Moderate | 117 Participants | 365 Participants | 129 Participants | 119 Participants |
| Investigator's Global Assessment (IGA) Severe | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Investigator's Global Assessment (IGA) | 2.7 score on a scale STANDARD_DEVIATION 0.48 | 2.7 score on a scale STANDARD_DEVIATION 0.46 | 2.7 score on a scale STANDARD_DEVIATION 0.45 | 2.7 score on a scale STANDARD_DEVIATION 0.46 |
| Patient Oriented Eczema Measure (POEM) Total Score | 16.6 score on a scale STANDARD_DEVIATION 5.03 | 16.1 score on a scale STANDARD_DEVIATION 5.14 | 16.1 score on a scale STANDARD_DEVIATION 5.49 | 15.7 score on a scale STANDARD_DEVIATION 4.88 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 58 Participants | 21 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 116 Participants | 39 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 8 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 113 Participants | 338 Participants | 114 Participants | 111 Participants |
| Rescue Medication No | 142 Participants | 431 Participants | 144 Participants | 145 Participants |
| Rescue Medication Yes | 30 Participants | 90 Participants | 33 Participants | 27 Participants |
| Rescue Medication Days | 1.4 days STANDARD_DEVIATION 0.72 | 1.5 days STANDARD_DEVIATION 1.26 | 1.7 days STANDARD_DEVIATION 1.85 | 1.3 days STANDARD_DEVIATION 0.78 |
| Sex: Female, Male Female | 118 Participants | 351 Participants | 122 Participants | 111 Participants |
| Sex: Female, Male Male | 54 Participants | 170 Participants | 55 Participants | 61 Participants |
| Smoking Status No | 142 Participants | 434 Participants | 148 Participants | 144 Participants |
| Smoking Status Yes | 30 Participants | 87 Participants | 29 Participants | 28 Participants |
| Weight | 84.144 kilograms STANDARD_DEVIATION 22.104 | 82.462 kilograms STANDARD_DEVIATION 20.805 | 81.908 kilograms STANDARD_DEVIATION 20.653 | 81.351 kilograms STANDARD_DEVIATION 19.603 |
| Worst Itch Numeric Rating Scale (WI-NRS) | 8.21 score on a scale STANDARD_DEVIATION 0.913 | 8.24 score on a scale STANDARD_DEVIATION 1.006 | 8.26 score on a scale STANDARD_DEVIATION 1.094 | 8.26 score on a scale STANDARD_DEVIATION 1.004 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 180 | 0 / 180 | 0 / 186 |
| other Total, other adverse events | 33 / 180 | 29 / 180 | 17 / 186 |
| serious Total, serious adverse events | 0 / 180 | 0 / 180 | 0 / 186 |
Outcome results
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| B244 O.D. 5.0 | Mean Change in Worst Itch Numeric Rating Scale (WI-NRS) | -2.8 score on a scale | Standard Error 0.184 |
| B244 O.D. 20.0 | Mean Change in Worst Itch Numeric Rating Scale (WI-NRS) | -2.8 score on a scale | Standard Error 0.184 |
| Vehicle | Mean Change in Worst Itch Numeric Rating Scale (WI-NRS) | -2.1 score on a scale | Standard Error 0.18 |
Comparison: 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.p-value: 0.0148ANCOVA
Comparison: 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.p-value: 0.0143ANCOVA
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.
Time frame: Baseline to Day 28
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| B244 O.D. 5.0 | Mean Change in 5-D Pruritus Scale | -5.2 score on a scale | Standard Error 0.228 |
| B244 O.D. 20.0 | Mean Change in 5-D Pruritus Scale | -5.2 score on a scale | Standard Error 0.229 |
| Vehicle | Mean Change in 5-D Pruritus Scale | -4.2 score on a scale | Standard Error 0.262 |
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0045Mixed Models Analysis
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0043Mixed Models Analysis
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| B244 O.D. 5.0 | Mean Change in Average Itch Numeric Rating Scale (AI-NRS) | -2.7 score on a scale | Standard Error 0.132 |
| B244 O.D. 20.0 | Mean Change in Average Itch Numeric Rating Scale (AI-NRS) | -2.7 score on a scale | Standard Error 0.132 |
| Vehicle | Mean Change in Average Itch Numeric Rating Scale (AI-NRS) | -2.1 score on a scale | Standard Error 0.164 |
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0044Mixed Models Analysis
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0077Mixed Models Analysis
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| B244 O.D. 5.0 | Mean Change in Patient Oriented Eczema Measure (POEM) | -6.4 score on a scale | Standard Error 0.342 |
| B244 O.D. 20.0 | Mean Change in Patient Oriented Eczema Measure (POEM) | -6.0 score on a scale | Standard Error 0.343 |
| Vehicle | Mean Change in Patient Oriented Eczema Measure (POEM) | -5.2 score on a scale | Standard Error 0.394 |
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0293Mixed Models Analysis
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.
Time frame: Baseline to Day 14
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| B244 O.D. 5.0 | Mean Change in Worst Itch Numeric Rating Scale (WI-NRS) | -2.0 score on a scale | Standard Error 0.138 |
| B244 O.D. 20.0 | Mean Change in Worst Itch Numeric Rating Scale (WI-NRS) | -2.0 score on a scale | Standard Error 0.137 |
| Vehicle | Mean Change in Worst Itch Numeric Rating Scale (WI-NRS) | -1.5 score on a scale | Standard Error 0.17 |
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0246Mixed Models Analysis
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0366Mixed Models Analysis
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.
Time frame: Baseline to Day 28
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 51 Participants |
| B244 O.D. 20.0 | Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 51 Participants |
| Vehicle | Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 38 Participants |
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS) | 54 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS) | 53 Participants |
| Vehicle | Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS) | 39 Participants |
Comparison: The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.p-value: 0.04Regression, Logistic
Comparison: The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.p-value: 0.0486Regression, Logistic
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.
Time frame: Baseline to Day 14
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 34 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 30 Participants |
| Vehicle | Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 21 Participants |
Comparison: The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.p-value: 0.0467Regression, Logistic
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS) | 118 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS) | 112 Participants |
| Vehicle | Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS) | 110 Participants |
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 120 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 115 Participants |
| Vehicle | Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS) | 105 Participants |
Comparison: The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.p-value: 0.0205Regression, Logistic
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| B244 O.D. 5.0 | Mean Change in Eczema Area Severity Index (EASI) | -3.9 score on a scale | Standard Error 0.249 |
| B244 O.D. 20.0 | Mean Change in Eczema Area Severity Index (EASI) | -4.0 score on a scale | Standard Error 0.25 |
| Vehicle | Mean Change in Eczema Area Severity Index (EASI) | -3.1 score on a scale | Standard Error 0.289 |
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0348Mixed Models Analysis
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0173Mixed Models Analysis
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).
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| B244 O.D. 5.0 | Mean Change in Investigator's Global Assessment (IGA) | -0.8 score on a scale | Standard Error 0.056 |
| B244 O.D. 20.0 | Mean Change in Investigator's Global Assessment (IGA) | -0.8 score on a scale | Standard Error 0.056 |
| Vehicle | Mean Change in Investigator's Global Assessment (IGA) | -0.5 score on a scale | Standard Error 0.064 |
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0026Mixed Models Analysis
Comparison: The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.p-value: 0.0005Mixed Models Analysis
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50) | 74 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50) | 76 Participants |
| Vehicle | Proportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50) | 60 Participants |
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0365Regression, Logistic
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75) | 46 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75) | 48 Participants |
| Vehicle | Proportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75) | 27 Participants |
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0086Regression, Logistic
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0035Regression, Logistic
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.
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90) | 25 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90) | 30 Participants |
| Vehicle | Proportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90) | 10 Participants |
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0074Regression, Logistic
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0008Regression, Logistic
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).
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4 | 81 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4 | 91 Participants |
| Vehicle | Proportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4 | 73 Participants |
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0195Regression, Logistic
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).
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement | 36 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement | 43 Participants |
| Vehicle | Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement | 21 Participants |
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0228Regression, Logistic
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0015Regression, Logistic
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).
Time frame: Baseline to Day 28
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 O.D. 5.0 | Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4 | 46 Participants |
| B244 O.D. 20.0 | Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4 | 62 Participants |
| Vehicle | Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4 | 34 Participants |
Comparison: Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.p-value: 0.0003Regression, Logistic