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Completed

NCT Number: NCT03758716

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

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

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FB825, FB825-15D11, Anti-CemX

Drug

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

Other names: FB825-15D11, Lot # 16-2056

Primary outcomes

  1. % Change From Baseline in Total IgE

    Time frame: Day 169

    Detect total IgE in serum by ImmunoCAP.

  2. % Change From Baseline in Allergen-specific IgE

    Time frame: Day 169

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

Secondary outcomes

  1. Change From Baseline in Total IgE

    Time frame: 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.

  2. % Change From Baseline in Allergen-specific IgE

    Time frame: 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)

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

    Time frame: Days 85

    VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.

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

    Time frame: Day 85

    EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

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

    Time frame: Days 169

    SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.

  6. % Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis

    Time frame: Days 169

    IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient.

  7. % Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis

    Time frame: Days 169

    BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient.

  8. Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs)

    Time frame: 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.

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

    Time frame: Day 57

    EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

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

    Time frame: Day 113

    EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

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

    Time frame: Day 141

    EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

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

    Time frame: Day 169

    EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

Sponsors and collaborators

Lead sponsor

Fountain Biopharma Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2018
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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