Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis

The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs and symptoms following the application of FB-401 in patients 2 years or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will be assessed by assessment of the skin and patient reports.

Inclusion Criteria:

• Male or female, ≥ 2 years of age
• Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit
• Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baseline/Day 1 using the validated IGA scale for atopic dermatitis
• EASI score ≥ 5 at the screening and the Baseline visit
• 5% to 30% (inclusive) body surface area of atopic dermatitis involvement at the screening and the baseline visit

Exclusion Criteria:

• Previous treatment within 4 weeks prior to the baseline visit with any of the following:
• Immunosuppressive or immunomodulating systemic drugs such as systemic (intravenous, oral, intra-articular or intramuscular) corticosteroids, azathioprine, methotrexate, cyclosporine
• Phototherapy or photo chemotherapy for atopic dermatitis
• Previous treatment within 1 week prior to the baseline visit with any of the following:
• Topical corticosteroids (does not include inhaled, intranasal or ophthalmic) or topical calcineurin inhibitors
• Topical phosphodiesterase type 4 (PDE4) inhibitor
• Use of emollients other than provided for the study
• Bleach baths
• Within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the baseline visit with Janus kinase inhibitors or other investigational drug
• Within16 weeks or 5 half-lives, whichever is longer, prior to the baseline visit with dupilumab or other biologic agent to treat atopic dermatitis
• Within 1 year prior to the baseline visit with any live bacterial therapy
• Pregnant (or planning to become pregnant during the period of the study) or lactating females