Study of FB-401 in patients with atopic dermatitis
Forte Biosciences, Inc is starting a new clinical trial of 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.
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.
The clinical trial started in June 2, 2021 and will continue throughout August 2022.
Adverse Events will be primary outcome measure. Safety evaluations.
The inclusion parameter is 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
Exclusion Criteria: - 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.
The excluding condition is 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.
The contacts and locations are the Center for Dermatology Clinical Research, Inc, Fremont, California, 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. For more details: https://ichgcp.net/clinical-trials-registry/NCT0493611
