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
Stopped early · Phase 2
Conditions studied: Atopic Dermatitis
In brief
The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.
Key facts
- Study ID
- NCT04936113
- Run by
- Forte Biosciences, Inc.
- People needed
- 36
- Starts
- 2021-06-02
- Expected to finish
- 2021-09-30
- Last updated by the study team
- 2021-10-28
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study
- Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor
You may not qualify if…
- Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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