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Atopic DermatitisPhase 2NCT05059509

Evaluate Efficacy 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 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
FB825
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTaiwan
Study dates
6 Feb 2020to 31 Mar 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 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 10 % 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.)
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  • 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.
  • 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 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.
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  • 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
  • Total bilirubin ≥1.5 × ULN
  • Serum creatinine ≥1.6 × ULN
  • Any other laboratory abnormality higher than or equal to grade 2 with the exception of IgE level, eosinophil counts, eosinophil cationic protein (ECP) and laboratory values mentioned above.
  • Note: Laboratory values may be converted to equivalent standard units. Retesting of abnormal laboratory values that may lead to exclusion will be allowed once (without prior sponsor approval). Retesting will take place during an unscheduled visit in the screening phase (before baseline).
  • The subject has received any approved or unapproved (ie, investigational) immunotherapy treatment within the past 3 months.
  • The subject has used any of the following classes of medication (prescription or over the counter):
  • Intranasal corticosteroid (eg, fluticasone propionate) within 30 days prior to dosing.
  • Systemic corticosteroids (eg, prednisone) within 30 days prior to dosing.
  • Leukotriene modifiers (eg, montelukast) within 30 days prior to dosing.
  • Immunosuppressants (eg, gold salts, methotrexate, azathioprine, cyclosporine) within the past 30 days prior to dosing.
  • Immunomodulating drugs (eg, interferon-gamma ) within the past 30 days prior to dosing.
  • Anti IgE (eg, omalizumab) within the past 1 years prior to dosing
  • Allergen immunotherapy within the past 1 years prior to dosing
  • Orally inhaled corticosteroids (eg, budesonide) within the past 30 days prior to dosing
  • The subject has received phototherapy within 4 weeks prior to dosing.
  • The subject has received live vaccine within 12 weeks prior to dosing.
  • The subject has known or suspected history of immunosuppression, including history of opportunistic infections (eg, TB) per investigator judgment.
  • The subject has history of malignancy within 5 years before the screening period.
  • High risk of parasite infection.
  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: An Open Labeled Exploratory Study to Evaluate Efficacy of FB825 in Adults With Atopic Dermatitis

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.

Being tested
FB825
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

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

Study groups in NCT05059509
Study groupRoleWhat they receive
FB825ExperimentalOne dose FB825, 5mg/kg, by 1 hour IV infusion on Day 1
Receives: Biological: FB825

What is being measured

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

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

    Measured: week 2 and 4

Secondary outcomes (6)

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

    Measured: week 2 and 4

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

    Measured: week 2 and 4

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

    Measured: week 2 and 4

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

    Measured: Weeks 2 and 4

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

    Measured: Weeks 2 and 4

  6. The mean change in Dermatology Life Quality Index (DLQI) from baseline

    Measured: Weeks 2 and 4

Timeline

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

  1. First posted28 Sep 2021
  2. Study start6 Feb 2020
  3. Primary completion10 May 2021
  4. Study completion31 Mar 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05059509
Sponsor's protocol ID
FB825CLIIS-04-AD
Status last verified
Sep 2021
First submitted
17 Sep 2021
Last updated
4 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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 1 site in Taiwan.

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 17 inclusion and 37 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: finished, 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 1 site in Taiwan. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in mIgE (Membrane bound Immunoglobulin E) B cell count (absolute and percentage) from baseline (time frame: week 2 and 4). 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 NCT05059509.

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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