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

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

Detailed Description
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: FB825, FB825-15D11, Anti-CemX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FB825<br>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. | Drug: FB825, FB825-15D11, Anti-CemX<br>* Pharmaceutical form: 20mg/ml solution Route of administration: IV<br>* Other names: FB825-15D11, Lot # 16-2056;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Change From Baseline in Total IgE | Detect total IgE in serum by ImmunoCAP. | Day 169 | 
| % Change From Baseline in Allergen-specific IgE | Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed) | Day 169 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total IgE | Detect total IgE in serum by ImmunoCAP. | 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) | 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. | 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. | 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. | Days 169 | 
| % Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis | IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient. | Days 169 | 
| % Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis | BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient. | Days 169 | 
| Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs) | Safety will be assessed by monitoring and recording of adverse events (AEs) and serious adverse event (SAEs); physical examination findings and vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature), clinical laboratory test results (hematology, coagulation, serum chemistry [including liver function tests, blood glucose level], and urinalysis); 12-lead ECG results. | through study completion, an average of 1 year. | 
| % 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. | Day 57 | 
| % 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. | Day 113 | 
| % 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. | Day 141 | 
| % 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. | Day 169 |