An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis

Fountain Biopharma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: FB825, FB825-15D11, Anti-CemX

Study type: Interventional

Funder types: Industry

Identifiers

NCT03758716

FB825CLIIS-01-AD

Details and patient eligibility

About

The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis

Full 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 subjects with atopic dermatitis (AD), who meet the criteria for study entry, will be enrolled to the one-arm-study.

Enrollment: 12 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects between 20 and 65 years of age, inclusive.
2. 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.
3. Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits.
4. Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and baseline visits.
5. ≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.

Exclusion criteria

1. Female subjects who are pregnant or lactating.
2. The subject is on diet or with poor intake.
3. The subject has a history of heart arrhythmias (any clinically relevant).
4. 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.
5. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

FB825

Experimental group

Description:

Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.

Treatment:

Drug: FB825, FB825-15D11, Anti-CemX