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

NCT ID: NCT03758716

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-03
• Study Completion Date: 2019-09-19

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FB825

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.

Group Type: EXPERIMENTAL

FB825, FB825-15D11, Anti-CemX

Intervention Type: DRUG

Pharmaceutical form: 20mg/ml solution Route of administration: IV

Interventions

FB825, FB825-15D11, Anti-CemX

Pharmaceutical form: 20mg/ml solution Route of administration: IV

Intervention Type: DRUG

Other Intervention Names

FB825-15D11, Lot # 16-2056

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fountain Biopharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia-Yu Chu, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FB825CLIIS-01-AD

Identifier Type: -

Identifier Source: org_study_id