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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

FB825, FB825-15D11, Anti-CemX

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FB825

Arm 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.

Outcomes

Primary Outcome Measures

% Change From Baseline in Total IgE

Detect total IgE in serum by ImmunoCAP.

% Change From Baseline in Allergen-specific IgE

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

Secondary Outcome Measures

Change From Baseline in Total IgE

Detect total IgE in serum by ImmunoCAP.

% Change From Baseline in Allergen-specific IgE

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

% 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.

% 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.

% 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.

% 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.

% 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.

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.