Clinical trial NCT04504279: Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
microbiome
probiotic
commensal Gram-negative bacteria
transdermal water loss
allergic diseases
dermatitis
eczema
skin diseases
skin diseases, eczematous
immune system diseases
Lead sponsor: Forte Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 154
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: EASI 50
timeFrame: 16 weeks
Secondary outcomes:
measure: Includes percent change in EASI
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Clarksville
country: United States
facility: DS Research
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Rockville
country: United States
facility: Lawrence J. Green MD LLC
state: Maryland
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Newtown Square
country: United States
facility: KGL Skin Study Center LLC
state: Pennsylvania
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
Study officials:
References:
citation: Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.