A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects With Atopic Dermatitis
Condition: Eczema; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      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: 
      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.
    

Intervention name(s): Experimental: B244
Intervention type(s): Drug
Intervention description(s): B244 suspension in 30ml/bottle
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive active product
Masking: None (Open Label)
Primary purpose: Treatment