Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study
NCT ID: NCT04936113
Last Updated: 2021-10-28
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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TERMINATED
PHASE2
36 participants
INTERVENTIONAL
2021-06-02
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FB-401
FB-401 applied topically
FB-401
Topical
Interventions
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FB-401
Topical
Eligibility Criteria
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Inclusion Criteria
* Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor
Exclusion Criteria
* Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological
* 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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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
DS Research
Louisville, Kentucky, United States
Cyn3rgy Research
New Brighton, Minnesota, United States
Cyn3rgy Research
Gresham, Oregon, United States
Bellaire Dermatology Associates
Bellaire, 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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FB401-02
Identifier Type: -
Identifier Source: org_study_id