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Allergic AsthmaPhase 2NCT05008965

Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma

A Phase 2 study testing FB825 in people with Allergic Asthma, run by Oneness Biotech Co., Ltd. at 13 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy and safety of FB825 in adult patients with moderate-to-severe allergic asthma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Allergic Asthma
What is being tested?
FB825
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
13 sitesTaiwan
Study dates
27 Jul 2021to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or females 18-75 years old.
  • Subjects diagnosed with moderate-to-severe allergic asthma [Global Initiative for Asthma [GINA]; GINA, 2021) at least 12 months prior to Visit 1.
  • Documented reversibility from historical data of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg albuterol/salbutamol (or other standard office practice) OR documented airway hyperresponsiveness (methacholine PC20 < 8 mg/mL [or PC20 < 16 mg/mL on ICS]) OR airflow variability in clinic FEV1 >12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Visit 1 if documented reversibility and airway hyperresponsiveness data are not available.
  • Subjects must have a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% predicted within 2 months from randomization.
  • Subjects must have received a physician-prescribed asthma regimen with medium- or high-dose ICS plus LABA for at least 3 month prior to Visit 1 and the dose of ICS must be stable for at least 30 days prior to Visit 1 and throughout the screening period.
  • High-dose ICS is defined as total daily dose of >500 mcg fluticasone propionate or equivalent
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  • Medium-dose ICS is defined as a total daily dose of 250 to 500 mcg fluticasone propionate or equivalent.
  • Equivalence ICS doses will be based upon the GINA guidelines (GINA, 2021)
  • According to the medical history, subject have no more than a maximum of 2000 mcg/day equipotent ICS daily dosage of fluticasone propionate or equivalent in 3 months before visit 1.
  • Prior to screening, subjects must be on a stable dose of any of the following doses and formulations of ICS/LABA combination therapy for at least 1 month:
  • Fluticasone/salmeterol combination therapy
  • Advair® Diskus - dry powder inhaler (DPI): 250/50 μg BID or 500/50 μg BID, or
  • Advair® HFA - metered dose inhaler (MDI): 230/42 μg BID or 460/42 μg BID, or
  • Budesonide/formoterol combination therapy (Symbicort® -160/4.5 μg BID or 320/9 μg BID), or
  • Mometasone/formoterol combination therapy (Dulera® -200/10 μg BID or 400/10 μg BID).
  • Other equivalents medium to-high dose medication following the GINA guidelines (GINA, 2021)
  • Subjects must have a documented history of protocol-defined asthma exacerbation at least 1 or more times within the 12 months.
  • A total serum IgE ≥ 125 IU/mL during screening prior to randomization.
  • Subjects must have at least one positive in skin prick test or at least one environmental allergen-specific IgE greater than normal range.
  • Uncontrolled asthma demonstrated both during the screening period and at the time of randomization defined as ACQ-5 (5-item Asthma Control Questionnaire) ≥ 1.5
  • If recently treated for respiratory tract infection, the treatment must have been completed at least 4 weeks prior to screening. Subjects who have an upper respiratory tract infection during screening are allowed to be rescreened 4 weeks after resolution.
  • 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 of child-bearing potential must have a negative serum pregnancy test at screening.
  • Note: The subject must use the methods of contraception mentioned above during study period and at least 120 days after the last dosing of FB825.
  • The subject has a body weight ≥ 40 kg at screening.
  • The subject has a normal or non clinically significant abnormal, as determined by the investigator, 12-lead electrocardiogram (ECG).
  • The subject is able to provide written informed consent.
  • The subject agrees to comply with all protocol requirements.

Who cannot join

  • Asthma exacerbation or any other reason requiring systemic steroids in the 30 days prior to randomization. Subjects are allowed to be rescreened 30 days after completion of treatment.
  • >20% relative change in post-bronchodilator FEV1 between screening and randomization.
  • Female subjects who are pregnant or lactating.
  • A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag/Ab combo test) at screening or subject taking antiretroviral medications, as determined by medical history.
  • Patients with positive HBeAg or HCV RNA results should be excluded as they are indications of active Hepatitis B virus and Hepatitis C virus replication.
  • Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease) other than allergic asthma.
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  • Use of any experimental drug within 30 days or 5 half-lives, whichever is longer, prior to or during the screening period.
  • Current or history of treatment with a monoclonal antibody, for example, IL-4, IL-5, IL-13 or IL-15 antibody treatment within 6 months prior to the screening.
  • Current or history of treatment with anti-IgE antibody treatment within 6 months or 5 half-lives, whichever is longer.
  • 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 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 indication of severe liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate transaminase (AST) above 3x upper limits of normal (ULN) or elevated total bilirubin >2x ULN as determined at screening.
  • The subject has severe kidney disease, defined as estimated GFR <30ml/min/1.73m2 or creatinine > 3x ULN.
  • The subject has known or suspected history of immunosuppression or immunodeficiency.
  • Known history of active tuberculosis (TB) or evidence of tuberculosis infection as defined by a positive purified protein derivative (PPD) skin test and/or interferon-gamma release assay. The interferon-gamma release assay should be repeated in case of an indeterminate result.
  • The subject has history of malignancy within 5 years before the screening period. Patients with non-invasive carcinoma in-situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin may be eligible if they have undergone curative resection at least 12 months prior to screening.
  • Current smoker with > 10 packs year prior to screening. A smoker is defined as a subject who has taken inhaled nicotine containing products (e.g. cigarette, cigar, pipe), including e-cigarettes prior to screening.
  • High risk of parasite infection
  • Risk factors for parasitic disease (living in an endemic area, 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.
  • The subject has received live vaccine within 12 weeks or COVID-19 vaccination within 2 weeks prior to dosing or planned live attenuated vaccinations during the study.
  • The subject has a history of any clinically relevant arrhythmias as determined by the investigator.
  • The subject has a history of respiratory failure or near fatal asthma events which resulted in intensive care unit admission or intubation within five years before the screening period.
  • History of anaphylaxis to any biologic therapy.
  • The subject has major surgery, for example organ replacement, joint replacement, full hysterectomy, heart surgeries, within 8 weeks before the screening. The subject who has major surgery prior to 8 weeks of screening should have fully recovered from any surgical procedures.
  • The subject has comorbid disease that might interfere with the evaluation of IMP (investigational medicinal product) or conduct of study procedures (eg, bronchodilator test).
  • The subject requiring non-selective beta-adrenergic receptor blockers for any reason and initiation or dose change of a selective beta-1 adrenergic receptor blocker within 3 months prior to Visit 1.
  • The subject who received bronchial thermoplasty within 3 years of Visit 1 OR patients who plan to begin therapy during the Screening Period or the Randomized Treatment Period.
  • The subject with active autoimmune disease (excluding atopic dermatitis) or patients using immunosuppressive therapy for autoimmune disease (excluding atopic dermatitis) (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) or patients with high titer autoantibodies at screening who are suspected of having high risk for developing autoimmune disease at the discretion of the Investigator or the Sponsor.
  • Use of Traditional Chinese Medications, those that are listed in the Prohibited Medication, for the treatment of asthma within 3 months prior to screening.
  • Aggravating factors that are inadequately controlled e.g., medication uncontrolled gastroesophageal reflux disease.
  • The subject has adrenal insufficiency (ACTH-resistant) by rapid ACTH stimulation test due to known history of adrenal insufficiency or being suspected of adrenal insufficiency or long-term use of systemic corticosteroids (annual average more than 6 months in the past two years).
  • Adrenal insufficiency: after 30 minutes of ACTH injection, the cortisol level ≦20 mg/ml in rapid ACTH stimulation test.
  • History of prior positive SARS-CoV-2 diagnostic test (antigen or NAAT/PCR) within 3 months prior to screening.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

June Kuo contact

+886 2 2703 1098

June.Kuo@onenessbio.com.tw

Pei-Jin Ho contact

+886 2 2703 1098

Peijin.Ho@onenessbio.com.tw

13 sites in 1 country

Taiwan13 sites, 13 recruiting

  • Kaohsiung Chang Gung Medical Foundation

    Kaohsiung City

    Chien-Hao Lai

    Chien-Hao Lai

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

    Chau-Chyun Sheu

    Chau-Chyun Sheu

    Recruiting

  • Far Eastern Memorial Hospital

    New Taipei City

    Shih-Lung Cheng

    Shih-Lung Cheng

    Recruiting

  • China Medical University Hospital

    Taichung

    Chia-Hung Chen, D7996@mail.cmuh.org.tw

    Chia-Hung Chen, MD

    Recruiting

  • Taichung Venterans General Hospital

    Taichung

    Pin-Kuei Fu

    Pin-Kuei Fu

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Xin-Min Liao

    Xin-Min Liao

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taipei

    Shu-Min Lin, MD, smlin100@gmail.com

    Shu-Min Lin, MD

    Recruiting

  • MacKay Memorial Hospital

    Taipei

    Sheng-Yah Shen

    Sheng-Yah Shen

    Recruiting

  • Ministry of Health and Welfare Shuang-Ho Hospital

    Taipei

    Kang-Yun Lee, PhD, leekangyun@tmu.edu.tw

    Kang-Yun Lee, MD, PhD

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Hao-Chien Wang, haochienwang@gmail.com

    Hao-Chien Wang, MD

    Recruiting

  • Taipei Medical University Hospital

    Taipei

    Han-Pin Kuo, PhD, hpk8828@gmail.com

    Han-Pin Kuo, MD, PhD

    Recruiting

  • Taipei Municipal Wanfang Hospital

    Taipei

    Chih-Hsin Lee, PhD, chleetw@tmu.edu.tw

    Chih-Hsin Lee, MD, PhD

    Recruiting

  • Taipei Veterans General Hospital

    Taipei

    Jia-Yih Feng, peterofeng@gmail.com

    Jia-Yih Feng, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase II Study to Evaluate the Efficacy and Safety of FB825 in Adult Patients With Moderate-to-severe Allergic Asthma

This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy and safety of FB825 in adult patients with moderate-to-severe allergic asthma.

Read the detailed description

The study comprises of a 4-week screening period, a 24-week treatment period and a 12-week follow-up period.

It is anticipated that approximately 100 subjects will be enrolled into this trial, in order to complete a total of 92 evaluable subjects. Eligible subjects will be randomized to receive placebo or FB825 in a 1:1 ratio.

Eligibility will be checked in patients with allergic asthma during the 4-week screening period. Potential candidates should provide signed informed consent forms before starting any screening activities. The subjects will receive one dose of 8 mg/kg FB825 or placebo, and five doses of 4 mg/kg FB825 or placebo every 4 weeks subsequently. The study drug will be administered as a 1-hour IV infusion.

Patients may administer albuterol (or equivalents) as rescue medications as needed throughout the study.

Prior to screening, patients must be on a stable dose of any of formulations of ICS/LABA combination therapy for at least 1 month. Patients who have been on medium to high dose medication according to the GINA guidelines (GINA, 2021) maintained at randomization (Day 1) will remain on their current treatment as background therapy.

ICS/LABA combination therapy during background therapy stable phase (Day -28 to Day 28) followed by ICS (fluticasone or equivalent) during ICS tapering phase (Day 29 to Day 112 or Day 140), and then followed by the FB825 monotherapy phase (Day 113 or Day 141 to Day 168).

Upon completing 24 weeks of treatment with the investigational product, patients will be placed on ICS/LABA combination therapy and albuterol (or equivalents) (as needed) to control their symptoms.

Conditions
Allergic Asthma
Being tested
FB825, Placebo

What participants receive

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

  • FB825Drug

    FB825 will be administered at 8 mg/kg for the first dose and 4 mg/kg for the other five doses.

  • PlaceboDrug

    Placebo will be administered at 8 mg/kg for the first dose and 4 mg/kg for the other five doses.

Study groups in NCT05008965
Study groupRoleWhat they receive
FB825ExperimentalNot described
Receives: Drug: FB825
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Occurrence of an exacerbation of asthma at week 24 after first dosing.

    Measured: week 24

Secondary outcomes (6)

  1. Mean change in morning peak expiratory flow (PEF) from baseline

    Measured: week 12, 16, and 24

  2. Change in ACQ 5 from baseline

    Measured: week 12, 16, and 24

  3. Percentage of patients achieving decrease in score by greater than or equal to 0.5 points on the ACQ (with a minimal importance difference improvement)

    Measured: week 12, 16, and 24

  4. Change in FEV1 from baseline

    Measured: week 12, 16, and 24

  5. Occurrence of an exacerbation of asthma

    Measured: week 12 and 16

  6. The incidence of treatment emergent adverse events throughout the study

    Measured: Week 24

Timeline

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

  1. First posted17 Aug 2021
  2. Study start27 Jul 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008965
Sponsor's protocol ID
FB825CLCT03
Status last verified
Jan 2026
First submitted
13 Feb 2021
Last updated
12 Jan 2026
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 Allergic Asthma, run by Oneness Biotech Co., Ltd. at 13 sites 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 27 inclusion and 36 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact June Kuo (+886 2 2703 1098, June.Kuo@onenessbio.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of an exacerbation of asthma at week 24 after first dosing. (time frame: week 24). 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 NCT05008965.

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 12 Jan 2026.

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