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

Forte Biosciences

Status and phase

Completed

Phase 2

Conditions

Atopic Dermatitis

Treatments

Biological: FB-401

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04504279

FB401-01

Details and patient eligibility

About

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.

Enrollment

154 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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