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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Biological: FB-401
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FB-401<br>FB-401 applied topically for 16 weeks. | Biological: FB-401<br>* Topical application<br>|
| Placebo Comparator: Placebo<br>Placebo applied topically for 16 weeks. | Biological: Placebo<br>* Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI 50 | The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16 | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Includes percent change in EASI | Percent change in EASI score is measured from baseline to Week 16 | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, microbiome, probiotic, commensal Gram-negative bacteria, transdermal water loss, allergic diseases, dermatitis, eczema, skin diseases, skin diseases, eczematous, immune system diseases