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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758716
• Other study ID #: FB825CLIIS-01-AD
• Status: Completed
• Phase: Phase 2
• Start date: July 3, 2017
• Est. completion date: September 19, 2019

Study information

• Verified date: April 2021
• Source: Fountain Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 19, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• FB825, FB825-15D11, Anti-CemX
Pharmaceutical form: 20mg/ml solution Route of administration: IV

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Fountain Biopharma Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Change From Baseline in Total IgE	Detect total IgE in serum by ImmunoCAP.	Day 169
Primary	% Change From Baseline in Allergen-specific IgE	Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)	Day 169
Secondary	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)
Secondary	% 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)
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	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.
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	% 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