Clinical trial NCT03758716: An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
Official title: An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Fountain Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: % Change From Baseline in Total IgE
timeFrame: Day 169
measure: % Change From Baseline in Allergen-specific IgE
timeFrame: Day 169
Secondary outcomes:
measure: Change From Baseline in Total IgE
timeFrame: Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)
measure: % Change From Baseline in Allergen-specific IgE
timeFrame: Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)
measure: % Changes From Baseline in Irritability Visual Analogue Scale (VAS)
timeFrame: Days 85
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Day 85
measure: % Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)
timeFrame: Days 169
measure: % Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis
timeFrame: Days 169
measure: % Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis
timeFrame: Days 169
measure: Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs)
timeFrame: through study completion, an average of 1 year.
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Day 57
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Day 113
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Day 141
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Day 169
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chia-Yu Chu, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: