A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Multiple Intravenous Doses of FB825 in Adults With Atopic Dermatitis

Oneness Biotech Co., Ltd.18 sites in 1 country99 target enrollmentMarch 10, 2020

ConditionsAtopic Dermatitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Oneness Biotech Co., Ltd.
Enrollment: 99
Locations: 18
Primary Endpoint: The mean change of Eczema Area and Severity Index [EASI] from baseline to Week 16
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study aims to evaluate the efficacy, improvement from baseline in Eczema Area and Severity Index (EASI) score, of multiple intravenous (IV) doses of FB825 in subjects with atopic dermatitis

Detailed Description

IgE plays an important role in mediating hypersensitivity reactions responsible for most of the allergic diseases, such as atopic dermatitis, asthma etc. which remain poorly controlled. FB825 blocks the biological pathway of IgE synthesis and thus can be used to treat IgE-mediated allergic diseases. FB825 was found to be safe when given IV repeat dose in toxicology study in monkey. No adverse effects of FB825 were observed in parameters included electrocardiograms for cardiovascular, ophthalmic examinations and other clinical, CNS and respiratory safety observations. The safety and tolerability of FB825 was demonstrated in the US phase I randomized, double-blind study with healthy subjects. Also, the FB825 was proved by in vivo study that it is able to block the biological pathway of IgE synthesis and thus can be used to treat IgE-mediated allergic diseases. Therefore, in this study, the effects of IgE in patients with atopic dermatitis receiving FB825 treatment will be investigated. The study will evaluate safety and efficacy in adults with atopic dermatitis.

Registry

clinicaltrials.gov

Start Date

March 10, 2020

End Date

June 30, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oneness Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject is male or female between 18 and 70 years of age.
•The subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on 2 years history of symptoms defined by the Eichenfield revised criteria of Hannifin and Rajka.
•Eczema Area and Severity Index (EASI) score ≧16 at the screening and baseline (Day 1) visits.
•Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≧ 3 (5-point scale) at the screening and baseline (Day 1) visits.
•≧10 % body surface area (BSA) of AD involvement at the screening and baseline (Day 1) visits.
•Note: BSA is measured as Part A (Extent) of SCORAD.
•Baseline pruritus numerical rating scale (NRS) average score for maximum itch intensity of ≧3, based on the average of daily pruritus NRS scores for maximum itch intensity reported during the 7 days prior to randomization.
•History of inadequate response to a stable (4 weeks) regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD within 6 months before the screening visit. (The regimen of topical corticosteroids means medium to higher potency, applied for at least 4 weeks or for the maximum duration recommended by product prescribing information.) 7.1 Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to vIGA-AD 0=clear to 2=mild) 7.2 Subjects with systemic treatment for AD in the past 6 months were also considered as inadequate responders to topical treatments and were potentially eligible for treatment with FB825 after appropriate washout.
•Patients must be applying stable doses of an additive-free, basic bland emollient twice-daily for at least 1 week immediately before the baseline visit (Day 1).
•Note: See exclusion criterion #11 for limitations regarding emollients

Exclusion Criteria

•Female subjects who are pregnant or lactating.
•The subject has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus antibodies at screening. Having a history of human immunodeficiency virus (HIV) infection.
•The subject has a history of drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
•The subject has a clinically significant, 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 is ineligible to participate in the study as judged by the investigator.
•The subject has a clinically significant history, as determined by the investigator, of drug allergies or hypersensitivity such as, but not limited to, sulfonamides and penicillin, or a drug allergy witnessed in a previous study with experimental drugs.
•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 TCS or TCI within 7 days before the baseline visit (Day 1).
•The subject has received any immunoglobulin products or blood products within 3 months of baseline visit (Day 1).
•The subject has received a biologic product (including investigational biologic product):

Outcomes

Primary Outcomes

The mean change of Eczema Area and Severity Index [EASI] from baseline to Week 16

Time Frame: 16 weeks

An EASI score is used to measure the extent (area) and severity of atopic eczema, the minimum EASI score is 0 and the maximum EASI score is 72, with the higher scores reflecting the worse severity of AD. The mean change of EASI reflects the participants whose disease changes.

Secondary Outcomes

The mean percentage change from baseline in Eczema Area and Severity Index [EASI ]score at Weeks 2, 4, 8, 12, 16, 20 and 24.(2, 4, 8, 12, 16, 20 and 24 weeks)
Proportion of patients with both validated Investigator Global Assessment [vIGA-AD] 0 to 1 and a reduction from baseline of ≥2 points at Weeks 2, 4, 8, 12, 16, 20 and 24.(2, 4, 8, 12, 16, 20 and 24 weeks)
The mean percentage change from baseline in validated Investigator Global Assessment [vIGA-AD] score at Weeks 2, 4, 8, 12, 16, 20 and 24.(2, 4, 8, 12, 16, 20 and 24 weeks)
Proportion of patients with Eczema Area and Severity Index≥50% [ EASI-50] ( ≥50% improvement from baseline) at Weeks 2, 4, 8, 12, 16, 20 and 24(2, 4, 8, 12, 16, 20 and 24 weeks)
Measure the profile of FB825 concentration in blood serum after administrating FB825.(1, 2, 3, 15, 29, 57, 85, 113, 141 and 169 days)
The mean percentage change from baseline in Eczema Area and Severity Index [EASI] score at Weeks 2, 4, 8, 12, 16, 20 and 24 in the population with at least one allergen-specific IgE response.(2, 4, 8, 12, 16, 20 and 24 weeks)
Proportion of patients with Eczema Area and Severity Index≥75% [ EASI-75] ( ≥75% improvement from baseline) at Weeks 2, 4, 8, 12, 16, 20 and 24(2, 4, 8, 12, 16, 20 and 24 weeks)
The mean percentage change from baseline in total IgE and allergen-specific IgE at Weeks 2, 4, 8, 12, 16, 20 and 24.(2, 4, 8, 12, 16, 20 and 24 weeks)
The incidence of adverse events(From day 1 to Day 169)
Proportion of patients with Eczema Area and Severity Index [EASI-90] ( ≥90 % improvement from baseline) at Weeks 2, 4, 8, 12, 16, 20 and 24(2, 4, 8, 12, 16, 20 and 24 weeks)
The mean percentage change from baseline in Pruritus Numerical Rating Scale (NRS) Score at Weeks 2, 4, 8, 12, 16, 20 and 24.(2, 4, 8, 12, 16, 20 and 24 weeks)
The mean change from baseline in Dermatology Life Quality Index [DLQI] score at Weeks 2, 4, 8, 12, 16, 20 and 24.(2, 4, 8, 12, 16, 20 and 24 weeks)