Evaluate Efficacy of FB825 in Adults With Atopic Dermatitis

NCT05059509 | Completed Phase 2

• 1 other identifier: FB825CLIIS-04-AD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open labeled exploratory study to evaluate efficacy of FB825 in adults with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan. Approximately 20 subjects with atopic dermatitis (AD), who meet the criteria for study entry, will be enrolled to the study. All eligible subjects will receive FB825, 5mg/kg, by 1 hour IV infusion on Day 1. Subjects will return to the study site on Days 15, 29 and 57 for the safety and efficacy evaluation. Subjects who premature withdraw from the study will have an end of study (EOS) visit within 7 days.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• The mean change in mIgE (Membrane bound Immunoglobulin E) B cell count (absolute and percentage) from baseline

  week 2 and 4

Secondary Outcomes (6)

• The mean percentage change in Pruritus Visual Analogue Scale (VAS) from baseline

  week 2 and 4

• The mean percentage change in Eczema Area and Severity Index (EASI) from baseline

  week 2 and 4

• The mean percentage change in Severity Scoring of Atopic Dermatitis Index (SCORAD) from baseline

  week 2 and 4

• The mean percentage change in Investigator Global Assessment (IGA) from baseline

  Weeks 2 and 4

• The mean percentage change in Body Surface Area (BSA) involved in atopic dermatitis from baseline to

  Weeks 2 and 4

Study Arms (1)

FB825

EXPERIMENTAL

One dose FB825, 5mg/kg, by 1 hour IV infusion on Day 1

Biological: FB825

Interventions

FB825 BIOLOGICAL

FB825, 5mg/kg, by 1 hour IV infusion on Day 1

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 between 20 and 65 years of age, inclusive.
• The subject has a physician confirmed diagnosis of chronic atopic dermatitis based on 3 year history of symptoms defined by the Eichenfield revised criteria of Hannifin and Rajka and supported by positive allergen specific IgE (immunoglobulin E) at the screening visit.
• Eczema Area and Severity Index (EASI) score 16 at the screening and baseline visits.
• Investigator's Global Assessment (IGA) score 3 (5 point scale) at the screening and baseline visits.
• % body surface area (BSA) of AD involvement at the screening and baseline visits.
• History of inadequate response to a stable (1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit. (The regimen of topical corticosteroids means medium to high potency, applied for at least 28 days or for the maximum duration recommended by product prescribing information.)
• Patients must be applying stable doses of emollient provided for atopic dermatitis twice daily for at least 7 days before the baseline visit.
• Female subjects of childbearing potential must use at least two forms of birth control. One must be barrier protection (i.e., condom or female condom) and the other is one of acceptable method of birth control (ie, diaphragm, intrauterine device, hormonal contraceptives, or abstinence) throughout the study. Subjects who are surgically sterile (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or postmenopausal (defined as amenorrhea for 12 consecutive months and documented serum follicle stimulating hormone level \>40 mU/mL) will be considered as no childbearing potential. All female subjects must have a negative serum pregnancy test prior to dosing.
• Note: The subject must use the method of contraception mentioned above during study period and in 16 weeks or 5 half lives after the last dosing of FB825.
• The subject has a body weight ≥ 40 kg at screening and a body mass index of 18.0 to 30.0 kg/m2, inclusive.
• The subject has a normal, as determined by the investigator, 12 lead electrocardiogram (ECG) with normal cardiac conduction parameters:
• Heart rate between 45 and 100 bpm;
• Fridericia corrected QT interval (QTcF) ≤450 milliseconds (men) or ≤470 milliseconds (women);
• QRS interval lower than 120 milliseconds.
• The subject is healthy, except atopic diseases, as determined by the investigator, on the basis of clinical laboratory test results performed at screening. If the results are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal not to be clinically significant.

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 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.
• The subject is under judicial supervision or curatorship.
• The subject has a clinically relevant, currently active or underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory (with the exception of uncomplicated allergic rhinitis), inflammatory, immunological, endocrine, diabetes, or infectious disease and ineligible to participate in the study judged by investigator.
• The subject has any history of a previous anaphylactic reaction.
• The subject has any condition that, in the opinion of the investigator, would compromise the study or the well being of the subject or prevent the subject from meeting or performing study requirements.
• The subject has received any immunoglobulin products or blood products within 3 months prior to dosing.
• The subject has received an biologic product:
• The subject has received any cell depleting agents, not only limited to rituximab, within 6 months prior to dosing, or before the lymphocyte count returns to normal, whichever is longer.
• The subject has received other biologics within 5 half lives (if known) or 16 weeks, which is longer, prior to dosing).
• The subject has one or more of the following laboratory abnormalities at screening as defined by Division of Microbiology and Infectious Diseases Adult Toxicity Table 2007:
• Aspartate aminotransferase or alanine aminotransferase (\>2 × upper limit of normal \[ULN\]) or higher

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: 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

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: September 17, 2021
• First Posted: September 28, 2021
• Study Start: February 6, 2020
• Primary Completion: May 10, 2021
• Study Completion: March 31, 2022
• Last Updated: April 4, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)