Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
NCT ID: NCT04504279
Last Updated: 2021-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2020-10-13
2021-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FB-401
FB-401 applied topically for 16 weeks.
FB-401
Topical application
Placebo
Placebo applied topically for 16 weeks.
Placebo
Vehicle
Interventions
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FB-401
Topical application
Placebo
Vehicle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
ALL
No
Sponsors
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Forte Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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First OC Dermatology
Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
DS Research
Clarksville, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
DS Research
Louisville, Kentucky, United States
Lawrence J. Green MD LLC
Rockville, Maryland, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States
Cyn3rgy Research
Gresham, Oregon, United States
KGL Skin Study Center LLC
Newtown Square, Pennsylvania, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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FB401-01
Identifier Type: -
Identifier Source: org_study_id
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