A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03775434|
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : July 31, 2020
An open-label, multicenter, Phase Ib study of B244 delivered as a topical spray to assess safety in pediatric subjects aged 2 to 17 years with atopic dermatitis
Condition or disease Intervention/treatment Phase Atopic Dermatitis (Eczema) Biological: B244 Phase 1b
|Condition or disease||Intervention/treatment||Phase|
|Eczema Atopic Dermatitis||Drug: Experimental: B244||Phase 1|
This is a Phase 1b, open-label, single arm, multiple site study assessing twice daily B244 application for 28 days in pediatric subjects with mild to moderate atopic dermatitis.
Number of Subjects:
The study will enroll 36 subjects in 3 cohorts of 12 subjects:
- Cohort 1: subjects aged 2 to 5 years.
- Cohort 2: subjects aged 6 to 11 years.
- Cohort 3, subjects aged 12 to 17 years.
At Screening and Baseline, all subjects must have confirmed diagnosis of atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% but no more than 60% body surface area and a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scale of 2 or 3.
The duration of the study will be approximately 7 weeks. Subjects will attend for a Screening visit between Days -21 and -14. If all eligibility criteria and none of the exclusion criteria are met, subjects will be enrolled into the study and will be required to undergo a 14 day washout period (Days-14 to -1). Subjects will attend the study center on Day 1 and the Baseline assessments will be performed before application of the first dose.
On confirmation of continued eligibility the subject and parent or guardian of the subject will be coached on how to apply medication, depending on the affected areas. They will be instructed to apply B244 twice daily (approximately 12 hours apart) for 28 days.
The first dose will be applied in the clinic under the supervision of clinical staff. Details of dose administration will be recorded in the study diary provided. The subjects with their parent or guardian will return to the study center on Days 7, 14, and 21 for completion of study assessments.
There will be a final study visit on Day 28, this will be defined as the end of the study for the subjects. A time window of ±2 day will be permitted for these 4 visits. There will not be a period of confinement in the study center all visits will be outpatient visits. Safety monitoring will include review of TEAEs, vital signs and physical examination. Efficacy will be assessed using EASI, vIGA-AD scale, POEM and ItchMan scores.
|Study Type :||Interventional|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects will receive active product|
|Masking:||None (Open Label)|
|Masking Description:||This is a single arm open label study. Subjects will be assigned to the study treatment arm. Each participant will be scheduled to receive investigational product (IP).|
|Official Title:||An Open-label, Multicenter, Phase Ib Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects Aged 2 to 17 Years With Atopic Dermatitis|
|Actual Study Start Date :||December 7, 2018|
|Actual Primary Completion Date :||May 18, 2019|
|Actual Study Completion Date :||June 10, 2019|
B244 suspension in 30ml/bottle
Drug: Experimental: B244
B244 suspension in 30ml/bottle
- Incidence of treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0 [ Time Frame: Baseline to Day 28 ]Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
- Clinically significant changes from baseline in physical exam. [ Time Frame: Baseline to Day 28 ]A physical exam will be conducted by a physician assessing systems (General appearance, Dermatological, Musculoskeletal, Thyroid, HEENT, Lyphatic, Respiratory, Gastrointestinal, Cardiovascular, Neurological, Extremeties, and other). Clinical significance of the physical exam will be determined at investigator's discretion.
- Clinically significant changes from baseline in Vital Signs [ Time Frame: Baseline to Day 28 ]Vital signs (temperature, respiratory rate, and pulse, ) will be obtained. Clinical significance of vital signs will be determined at the investigator's discretion.
- Changes in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). [ Time Frame: Baseline to Day 28 ]The vIGA-AD is a physician assessment ranking of Atopic Dermatitis symptoms from 0-clear, to 4- severe
- Changes in Area Severity Index (EASI) score. [ Time Frame: Baseline to Day 28 ]The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
- Changes in Patient Oriented Eczema Measure (POEM total score and each of the 7 components). [ Time Frame: Baseline to Day 28 ]This survey is 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points. A higher total score indicates a higher severity of disease.
- Changes in patient reported outcome (self-reported ItchMan scale). [ Time Frame: Baseline to Day 28 ]The Burn Man Itch Scale is used as a self report tool for subjects to indicate how itchy the area of atopic dermatitis feels at the timepoints during the study. It's reported on a scale between 0-comfortable, no itch and 4-Itches most terribly; impossible to sit still; concentrate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775434
|United States, Arkansas|
|Dermatology Trial Associates|
|Bryant, Arkansas, United States, 72022|
|United States, California|
|L.A. Universal Research Center, Inc.|
|Los Angeles, California, United States, 90057|
|United States, Indiana|
|The Indiana Clinical Trials Center|
|Plainfield, Indiana, United States, 46168|
|United States, Minnesota|
|Minnesota Clinical Study Center|
|Fridley, Minnesota, United States, 55432|
|United States, Nebraska|
|Skin Specialists, PC|
|Omaha, Nebraska, United States, 68144|
|United States, Virginia|
|Virginia Clinical Research, INC|
|Norfolk, Virginia, United States, 23502|
|Study Director:||Judith Ng-Cashin, MD||Chief Medical Officer|
|Study Director:||Spiros Jamas, ScD||AOBiome Therapeutics|