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

NCT03758716 | Completed Phase 2 Results

• 1 other identifier: FB825CLIIS-01-AD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• % Change From Baseline in Total IgE

  Detect total IgE in serum by ImmunoCAP.

  Day 169

• % Change From Baseline in Allergen-specific IgE

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

  Day 169

Secondary Outcomes (12)

• 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)

• % 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)

• % Changes From Baseline in Irritability Visual Analogue Scale (VAS)

  Days 85

• % Changes From Baseline in Eczema Area and Severity Index (EASI)

  Day 85

• % Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)

  Days 169

Study Arms (1)

FB825

EXPERIMENTAL

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.

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

Interventions

FB825, FB825-15D11, Anti-CemX DRUG

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

Also known as: FB825-15D11, Lot # 16-2056

FB825

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fountain Biopharma Inc.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: NienYi Chen PhD
• Organization: Oneness Biotech Co., Ltd.

nienyichen@onenessbio.com.tw

+886 2 2655 8687

Study Officials

• Chia-Yu Chu, MD-PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 29, 2018
• Study Start: July 3, 2017
• Primary Completion: January 28, 2019
• Study Completion: September 19, 2019
• Last Updated: April 22, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)