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

Phase 2

Completed

Conditions: Atopic Dermatitis

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

Registration Number: NCT03758716

Lead Sponsor: Fountain Biopharma Inc.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FB825	FB825, FB825-15D11, Anti-CemX	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.

Primary Outcome Measures

Name	Time	Method
% Change From Baseline in Total IgE	Day 169	Detect total IgE in serum by ImmunoCAP.
% Change From Baseline in Allergen-specific IgE	Day 169	Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)

Secondary Outcome Measures

Name	Time	Method
% Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis	Days 169	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 Eczema Area and Severity Index (EASI)	Day 169	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)	Days 169	SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.
Change From Baseline in Total IgE	Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)	Detect total IgE in serum by ImmunoCAP.
% Change From Baseline in Allergen-specific IgE	Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)	Detect specific IgE in serum by ImmunoCAP. (Dog dander)
% Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis	Days 169	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)	through study completion, an average of 1 year.	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.
% Changes From Baseline in Irritability Visual Analogue Scale (VAS)	Days 85	VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.