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Atopic DermatitisPhase 2NCT04413942

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

A Phase 2 study testing FB825 in people with Atopic Dermatitis, run by Oneness Biotech Co., Ltd. at 18 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
FB825
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
18 sitesUnited States
Study dates
10 Mar 2020to 30 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • 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.

Who cannot join

  • 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.
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  • 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):
  • 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.
  • 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.
  • The subject regular use (≧2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit (Day 1).
  • The subject has received any immunotherapy treatment within 3 months of baseline visit (Day 1).
  • 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
  • The subject has received phototherapy within 4 weeks before study treatment.
  • The subject has received live vaccine within 12 weeks before the study treatment.
  • The subject has presence of skin comorbidities that may interfere with study assessments.
  • The subject has known or suspected history of immunosuppression, including history of opportunistic infections (e.g., TB) per investigator's judgment.
  • 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.
  • 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.
  • The subject planned or anticipated use of any prohibited medications and procedures during study treatment.
  • The subject planned or anticipated major surgical procedure during the patient's participation in this study.
  • 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
  • Judged by investigator due to non-compliance with the study requirement or severe concomitant illness.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Oakland Hills Dermatology (PCRS Network)

    Auburn Hills, Michigan, 48326

  • Zenith Research

    Beverly Hills, California, 90212

  • University Clinical Research - Deland, LLC

    DeLand, Florida, 32720

  • Encino Research Center

    Encino, California, 91436

  • FXM Clinical Research Ft. Lauderdale, LLC.

    Fort Lauderdale, Florida, 33308

  • Sweet Hope Research Specialty

    Hialeah, Florida, 33016

  • Universal Axon - Homestead, LLC

    Homestead, Florida, 33030

  • Marvel Research 002, LLC

    Huntington Beach, California, 92647

  • FXM Clinical Research Miramar, LLC

    Miramar, Florida, 33027

  • FXM Clinical Research Miami, LLC

    Miramar, Florida, 33175

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Paddington Testing Co, Inc

    Philadelphia, Pennsylvania, 19103

  • Clinical Research Partners

    Richmond, Virginia, 23226

  • ACRC Studies

    San Diego, California, 92119

  • Unison Clinical Trials

    Sherman Oaks, California, 991403

  • Moore Clinical Research

    Tampa, Florida, 33609

  • Avita Clinical Research (PCRS Network)

    Tampa, Florida, 33613

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

Other trials in United States

About this study

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

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

Read the 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.

Being tested
FB825, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FB825Biological

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

  • PlaceboOther

    Formulation buffer

Study groups in NCT04413942
Study groupRoleWhat they receive
FB825Active comparatorFB825
Receives: Biological: FB825
PlaceboPlacebo comparatorFormulation buffer
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks

Secondary outcomes (12)

  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

    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.

    Measured: 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.

    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.

    Measured: 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

    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.

    Measured: 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

    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.

    Measured: 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.

    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.

    Measured: 2, 4, 8, 12, 16, 20 and 24 weeks

  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.

    Proportion of patients with both vIGA-AD 0 to 1 and a reduction from baseline

    Measured: 2, 4, 8, 12, 16, 20 and 24 weeks

  7. The mean percentage change from baseline in Pruritus Numerical Rating Scale (NRS) Score at Weeks 2, 4, 8, 12, 16, 20 and 24.

    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.

    Measured: 2, 4, 8, 12, 16, 20 and 24 weeks

  8. The mean percentage change from baseline in total IgE and allergen-specific IgE at Weeks 2, 4, 8, 12, 16, 20 and 24.

    Percentage change from baseline in total IgE and allergen-specific IgE

    Measured: 2, 4, 8, 12, 16, 20 and 24 weeks

  9. Measure the profile of FB825 concentration in blood serum after administrating FB825.

    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.

    Measured: 1, 2, 3, 15, 29, 57, 85, 113, 141 and 169 days

  10. The mean change from baseline in Dermatology Life Quality Index [DLQI] score at Weeks 2, 4, 8, 12, 16, 20 and 24.

    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.

    Measured: 2, 4, 8, 12, 16, 20 and 24 weeks

  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.

    Mean change from baseline in EASI score

    Measured: 2, 4, 8, 12, 16, 20 and 24 weeks

  12. The incidence of adverse events

    AE events

    Measured: From day 1 to Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start10 Mar 2020
  3. Primary completion31 Dec 2021
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Arm A: FB825 Arm B: Placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04413942
Sponsor's protocol ID
FB825CLRS01
Status last verified
Sep 2021
First submitted
13 Apr 2020
Last updated
4 Apr 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FB825 in people with Atopic Dermatitis, run by Oneness Biotech Co., Ltd. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean change of Eczema Area and Severity Index [EASI] from baseline to Week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04413942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.

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