A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Eczema, Atopic Dermatitis

Intervention / Treatment
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* Drug: Experimental: B244


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: Male and female subjects 2 to 17 years of age, inclusive. Confirmed diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria. A minimum of 10% but no more than 60% of the subjects' body surface area (see Appendix 6 for guidance) is affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, and excoriation; with the excoriation serving as the physical examination correlate of pruritus). A vIGA-AD scale of 2 or 3 at Screening and Baseline. Subject, or the parent or guardian, to provide written informed consent and authorization for protected health information disclosure. Subjects must be generally in good health based on Investigator's assessment (other than atopic dermatitis). Normal vital signs, or with no clinically significant vital signs that in the opinion of the Investigator, would place the subject at increased risk or would confound the objectives of the study. Females must not be pregnant, as confirmed by negative urine pregnancy testing. Female subjects aged ≥11 years old, or female patients <11 years old who have started menstruating, will have urinary pregnancy test performed at Screening and prior to the first dose with negative results in order to participate in the study. Females must either practice abstinence from heterosexual contact or use one of the highly effective contraceptive options described in the Appendix 5. Male subjects of reproductive potential, must be willing to practice effective contraception during the study while receiving study treatment from Day 1 and for 7 days after the last study visit (Day 28). Ability to comprehend and comply with study procedures. Agree to commit to participate in the current protocol. Provide written informed consent prior to any study procedure being performed. Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: Clinically significant physical or mental disorder which, in the opinion of the Investigator, would place the subject at increased risk or would confound the objectives of the study. Subjects with atopic dermatitis on the face only. Active cutaneous bacterial, viral or fungal infection in any treatment area at Baseline (eg, clinically infected atopic dermatitis). History or presence of immunological deficiencies or diseases, organ transplant, human immunodeficiency virus (HIV), diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant renal disease severe hepatic disorders, or other severe uncontrolled conditions (eg, drug or alcohol abuse), that are significant and/or that may pose a health risk to the subject in the study or may have an impact on the study assessments. Unstable atopic dermatitis or a consistent requirement for high-potency corticosteroids (class I-III steroids). Active systemic or localized infection (including infected AD). Subjects unable to comply with the excluded medication/therapy restriction Known hypersensitivity to the study treatment. Known to have hepatitis B, hepatitis C or HIV I or II tests. Details will be recorded in medical history, a blood sample will not be collected for confirmation. Female subject who is pregnant, breastfeeding, or considering pregnancy during the study. Any skin condition which in the Investigator's opinion may interfere with the evaluation of atopic dermatitis. Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than 5 times the drug's half-life, whichever is longer. Use of any biologic within a period of 5 times its half-life. Children or relatives of the Sponsor, clinical research organization, or the Study Site personnel are excluded from participating in the study.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive active product
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B244<br>B244 suspension in 30ml/bottle | Drug: Experimental: B244<br>* B244 suspension in 30ml/bottle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0 | Safety and tolerability endpoints will consist of all adverse events reporting during the study duration. | Baseline to Day 28 | 
| Clinically significant changes from baseline in physical exam. | 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. | Baseline to Day 28 | 
| Clinically significant changes from baseline in Vital Signs | Vital signs (temperature, respiratory rate, and pulse, ) will be obtained. Clinical significance of vital signs will be determined at the investigator's discretion. | Baseline to Day 28 |