Status:
COMPLETED
An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
Lead Sponsor:
Fountain Biopharma Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis
Detailed Description
This is an open-labeled exploratory study to evaluate safety and efficacy of FB825 in adults with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan. Approximately 12 s...
Eligibility Criteria
Inclusion
- Male or female subjects between 20 and 65 years of age, inclusive.
- The subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on 3 years history of symptoms defined by the Eichenfield revised criteria of Hannifin and Rajka and supported by positive allergen-specific IgE at the screening visit.
- Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits.
- Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and baseline visits.
- ≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.
Exclusion
- Female subjects who are pregnant or lactating.
- The subject is on diet or with poor intake.
- The subject has a history of heart arrhythmias (any clinically relevant).
- The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 and 2 antibodies at screening.
- The subject has a history of alcohol or drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
Key Trial Info
Start Date :
July 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03758716
Start Date
July 3 2017
End Date
September 19 2019
Last Update
April 22 2021
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan