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
Phase 2
Terminated
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: FB-401
- Registration Number
- NCT04936113
- Lead Sponsor
- Forte Biosciences, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FB-401 FB-401 FB-401 applied topically
- Primary Outcome Measures
Name Time Method Number of adverse events 52 weeks Safety evaluations
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
MedaPhase, Inc
🇺🇸Newnan, Georgia, United States
DS Research
🇺🇸Louisville, Kentucky, United States
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States