Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: PlaceboBiological: FB-401
- Registration Number
- NCT04504279
- Lead Sponsor
- Forte Biosciences, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo applied topically for 16 weeks. FB-401 FB-401 FB-401 applied topically for 16 weeks.
- Primary Outcome Measures
Name Time Method EASI 50 16 weeks The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
- Secondary Outcome Measures
Name Time Method Includes percent change in EASI 16 weeks Percent change in EASI score is measured from baseline to Week 16
Trial Locations
- Locations (14)
Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
Midwest Children's Health Research Institute
🇺🇸Lincoln, Nebraska, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
MedaPhase, Inc.
🇺🇸Newnan, Georgia, United States
DS Research
🇺🇸Louisville, Kentucky, United States
KGL Skin Study Center LLC
🇺🇸Newtown Square, Pennsylvania, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Dermatology Consulting Services, PLLC
🇺🇸High Point, North Carolina, United States
Lawrence J. Green MD LLC
🇺🇸Rockville, Maryland, United States
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States