NCT04936113

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

An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Forte Biosciences, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	FB-401	Topical

Timeline

• Start date: 2021-06-02
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2021-06-23
• Last updated: 2021-10-28

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study