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

Fountain Biopharma Inc.12 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

FB825, FB825-15D11, Anti-CemXDRUG

Pharmaceutical form: 20mg/ml solution Route of administration: IV

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

% Change From Baseline in Total IgE

Detect total IgE in serum by ImmunoCAP.

Time frame: Day 169

% Change From Baseline in Allergen-specific IgE

Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)

Time frame: Day 169

Secondary Outcomes

Change From Baseline in Total IgE

Detect total IgE in serum by ImmunoCAP.

Time frame: Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)

% Change From Baseline in Allergen-specific IgE

Detect specific IgE in serum by ImmunoCAP. (Dog dander)

Time frame: Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)

% Changes From Baseline in Irritability Visual Analogue Scale (VAS)

VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.

Time frame: Days 85

% Changes From Baseline in Eczema Area and Severity Index (EASI)

EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

Time frame: Day 85

% Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)

SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.

Time frame: Days 169

Data from ClinicalTrials.gov

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