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

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ClinicalTrials.gov Identifier: NCT04413942
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Oneness Biotech Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: FB825 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm A: FB825 Arm B: Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: FB825
FB825
Biological: FB825
Humanized monoclonal IgG1 specifically targeting the CεmX domain of membrane-bound IgE

Placebo Comparator: Placebo
Formulation buffer
Other: Placebo
Formulation buffer




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 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. EASI-75 responders were the participants who achieved >=75% overall improvement in EASI score at Week 2, 4, 8, 12, 16, 20 and 24 weeks.

  2. The mean percentage change from baseline in Eczema Area and Severity Index [EASI ]score at Weeks 2, 4, 8, 12, 16, 20 and 24. [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 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 from baseline at Week 2, 4, 8, 12, 16, 20 and 24 weeks.

  3. 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 [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 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. EASI-50 responders were the participants who achieved >=50% overall improvement in EASI score at Week 2, 4, 8, 12, 16, 20 and 24 weeks.

  4. 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 [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 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. EASI-90 responders were the participants who achieved >=90% overall improvement in EASI score at Week 2, 4, 8, 12, 16, 20 and 24 weeks.

  5. The mean percentage change from baseline in validated Investigator Global Assessment [vIGA-AD] score at Weeks 2, 4, 8, 12, 16, 20 and 24. [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 weeks ]
    v-IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe). The mean percentage change of vIGA-AD score reflects the participants whose disease changes from baseline at Week 2, 4, 8, 12, 16, 20 and 24.

  6. 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. [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 weeks ]
    Proportion of patients with both vIGA-AD 0 to 1 and a reduction from baseline

  7. The mean percentage change from baseline in Pruritus Numerical Rating Scale (NRS) Score at Weeks 2, 4, 8, 12, 16, 20 and 24. [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 weeks ]
    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). The mean percentage change of NRS reflects the changes of participants in itch intensity.

  8. The mean percentage change from baseline in total IgE and allergen-specific IgE at Weeks 2, 4, 8, 12, 16, 20 and 24. [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 weeks ]
    Percentage change from baseline in total IgE and allergen-specific IgE

  9. Measure the profile of FB825 concentration in blood serum after administrating FB825. [ Time Frame: 1, 2, 3, 15, 29, 57, 85, 113, 141 and 169 days ]
    Analyze how the absorption and distribution of FB825 in body, the participant's blood will be analyzed for FB825 concentration at various time points (1, 2, 3, 15, 29, 57, 85, 113, 141 and 169 days) after receiving FB825 dose.

  10. The mean change from baseline in Dermatology Life Quality Index [DLQI] score at Weeks 2, 4, 8, 12, 16, 20 and 24. [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 weeks ]
    The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL. The mean change of DLQI from baseline reflects the QOL changes of participants.

  11. 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. [ Time Frame: 2, 4, 8, 12, 16, 20 and 24 weeks ]
    Mean change from baseline in EASI score

  12. The incidence of adverse events [ Time Frame: From day 1 to Day 169 ]
    AE events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is male or female between 18 and 70 years of age.
  2. 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.
  3. Eczema Area and Severity Index (EASI) score ≧16 at the screening and baseline (Day 1) visits.
  4. Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≧ 3 (5-point scale) at the screening and baseline (Day 1) visits.
  5. ≧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.

  6. 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.
  7. 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.
  8. 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

  9. 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.

  10. The subject is able to provide written informed consent.
  11. The subject agrees to comply with all protocol requirements.

Exclusion Criteria:

  1. Female subjects who are pregnant or lactating.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. The subject has any history of a previous anaphylactic reaction.
  7. 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.
  8. The subject has received TCS or TCI within 7 days before the baseline visit (Day 1).
  9. The subject has received any immunoglobulin products or blood products within 3 months of baseline visit (Day 1).
  10. The subject has received a biologic product (including investigational biologic product):

    10.1 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.

    10.2 Other biologics such as dupilumab within 5 half-lives (if known) or within 16 weeks, whichever is longer, before the study treatment.

  11. 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)
  12. The subject has received an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before study treatment.
  13. The subject is a member of the professional or ancillary personnel involved in the study.
  14. The subject regular use (≧2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit (Day 1).
  15. The subject has received any immunotherapy treatment within 3 months of baseline visit (Day 1).
  16. The subject has used any of the following classes of medication (prescription or over the counter):

    16.1 Systemic corticosteroids within 4 weeks before the study treatment 16.2 Leukotriene modifiers within 4 weeks before the study treatment 16.3 Cyclosporine within 12 weeks before the study treatment, or other immunosuppressants (e.g. gold salts, methotrexate, azathioprine) within 4 weeks before the study treatment 16.4 IFN-gamma within 12 weeks before the study treatment, or other immunomodulating drugs within 4 weeks before the study treatment 16.5 Anti-IgE (e.g., omalizumab) within 1 year before the study treatment 16.6 Allergen immunotherapy within 1 year before the study treatment

  17. The subject has received phototherapy within 4 weeks before study treatment.
  18. The subject has received live vaccine within 12 weeks before the study treatment.
  19. The subject has presence of skin comorbidities that may interfere with study assessments.
  20. The subject has known or suspected history of immunosuppression, including history of opportunistic infections (e.g., TB) per investigator's judgment.
  21. The subject has active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.

    Note: Patients may be rescreened after infection resolves.

  22. The subject has history of malignancy within 5 years before the screening period, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
  23. The subject planned or anticipated use of any prohibited medications and procedures during study treatment.
  24. The subject planned or anticipated major surgical procedure during the patient's participation in this study.
  25. High risk of parasite infection

    Evidence of parasitic infection defined as having the following two items:

    25.1 Risk factors for parasitic disease (living in an endemic area, chronic gastrointestinal symptoms, travel within the last 6 months to regions where geohelminthic infections are endemic, and/or chronic immunosuppression) AND 25.2 Evidence of parasitic colonization or infection on stool evaluation for ova and parasites.

    Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than twice the upper limit of normal

  26. Judged by investigator due to non-compliance with the study requirement or severe concomitant illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413942


Contacts
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Contact: NienYi Chen, PhD +886 2 2655 8687 ext 653 nienyichen@onenessbio.com.tw

Locations
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United States, California
Zenith Research Recruiting
Beverly Hills, California, United States, 90212
Contact: David Stoll, MD         
Principal Investigator: David Stoll, MD         
Marvel Research 002, LLC Recruiting
Huntington Beach, California, United States, 92647
Contact: Brian Siu, MD         
Principal Investigator: Brian Siu, MD         
Providence Clinical Research Recruiting
North Hollywood, California, United States, 91606
Contact: Teresa S. Sligh, MD         
Principal Investigator: Teresa S. Sligh, MD         
ACRC Studies Not yet recruiting
San Diego, California, United States, 92119
Contact: Mirwais Saifi, MD         
Principal Investigator: Mirwais Saifi, MD         
United States, Florida
Sweet Hope Research Specialty Recruiting
Hialeah, Florida, United States, 33016
Contact: Martin Zaiac, MD         
Principal Investigator: Martin Zaiac, MD         
Universal Axon - Homestead, LLC Recruiting
Homestead, Florida, United States, 33030
Contact: Jose Cobiella, MD         
Principal Investigator: Jose Cobiella, MD         
FXM Clinical Research Miramar, LLC Recruiting
Miramar, Florida, United States, 33027
Contact: Francisco Flores, MD         
Principal Investigator: Francisco Flores, MD         
FXM Clinical Research Miami, LLC Recruiting
Miramar, Florida, United States, 33175
Contact: Hector Wiltz, MD         
Principal Investigator: Hector Wiltz, MD         
Moore Clinical Research Recruiting
Tampa, Florida, United States, 33609
Contact: Julian Melamed, MD         
Principal Investigator: Julian Melamed, MD         
Avita Clinical Research (PCRS Network) Recruiting
Tampa, Florida, United States, 33613
Contact: Thomas M. Taylor, MD         
Principal Investigator: Thomas M. Taylor, MD         
United States, Michigan
Oakland Hills Dermatology (PCRS Network) Recruiting
Auburn Hills, Michigan, United States, 48326
Contact: Christofer Buatti, MD         
Principal Investigator: Christofer Buatti, MD         
Revival Research Institute, LLC Recruiting
Troy, Michigan, United States, 48084
Contact: Ali Moiin, MD         
Principal Investigator: Ali Moiin, MD         
United States, Pennsylvania
Paddington Testing Co, Inc Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Jennifer Parish, MD         
Principal Investigator: Lawrence Parish, MD         
United States, Virginia
Clinical Research Partners Recruiting
Richmond, Virginia, United States, 23226
Contact: Robert Call, MD         
Principal Investigator: Robert Call, MD         
Sponsors and Collaborators
Oneness Biotech Co., Ltd.
Investigators
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Principal Investigator: NienYi Chen, PhD Oneness Biotech
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Responsible Party: Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04413942    
Other Study ID Numbers: FB825CLRS01
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases