Evaluate Efficacy, PK, and Safety of FB825 in Adults With Atopic Dermatitis

NCT04413942 | Unknown Phase 2 FDA Drug

• 1 other identifier: FB825CLRS01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 18

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  16 weeks

Secondary Outcomes (12)

• 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 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 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

• 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 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

Study Arms (2)

FB825

ACTIVE COMPARATOR

FB825

Biological: FB825

Placebo

PLACEBO COMPARATOR

Formulation buffer

Other: Placebo

Interventions

FB825 BIOLOGICAL

Humanized monoclonal IgG1 specifically targeting the CεmX domain of membrane-bound IgE

FB825

Placebo OTHER

Formulation buffer

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Female subjects of childbearing potential must use an acceptable method of birth control (i.e., diaphragm, intrauterine device, condom, hormonal contraceptives, or abstinence) throughout the study or be surgically sterile (i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or postmenopausal (defined as amenorrhea 12 consecutive months and documented serum follicle stimulating hormone level \>40 mU/mL). All female subjects must have a negative serum pregnancy test at screening and baseline (Day 1) visits.
• Note: The subject must use the method of effective contraception during study period and in 16 weeks or 5 half-lives after the last dosing of FB825.
• The subject is able to provide written informed consent.
• The subject agrees to comply with all protocol requirements.

You may not qualify if:

• 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):
• Any cell-depleting agents, not only limited to rituximab, within 6 months of baseline visit (Day 1), or before the lymphocyte count returns to normal, whichever is longer.
• Other biologics such as dupilumab within 5 half-lives (if known) or within 16 weeks, whichever is longer, before the study treatment.
• Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
• The subject has received an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before study treatment.
• The subject is a member of the professional or ancillary personnel involved in the study.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (18)

Zenith Research

Beverly Hills, California, 90212, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

Marvel Research 002, LLC

Huntington Beach, California, 92647, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

ACRC Studies

San Diego, California, 92119, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 991403, United States

Location

University Clinical Research - Deland, LLC

DeLand, Florida, 32720, United States

Location

FXM Clinical Research Ft. Lauderdale, LLC.

Fort Lauderdale, Florida, 33308, United States

Location

Sweet Hope Research Specialty

Hialeah, Florida, 33016, United States

Location

Universal Axon - Homestead, LLC

Homestead, Florida, 33030, United States

Location

FXM Clinical Research Miramar, LLC

Miramar, Florida, 33027, United States

Location

FXM Clinical Research Miami, LLC

Miramar, Florida, 33175, United States

Location

Moore Clinical Research

Tampa, Florida, 33609, United States

Location

Avita Clinical Research (PCRS Network)

Tampa, Florida, 33613, United States

Location

Oakland Hills Dermatology (PCRS Network)

Auburn Hills, Michigan, 48326, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Clinical Research Partners

Richmond, Virginia, 23226, United States

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 Officials

• NienYi Chen, PhD

  Oneness Biotech

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm A: FB825 Arm B: Placebo

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: June 4, 2020
• Study Start: March 10, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: April 4, 2022

Record last verified: 2021-09

Locations

US (18)