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Protocol NumberFB825CLCT03

2021-07-27 - 2025-06-30

Phase II

Not yet recruiting5

Recruiting12

ICD-10J45.41

Moderate persistent asthma with (acute) exacerbation

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

  • Trial Applicant

    ONENESS BIOTECH CO., LTD.

  • Sponsor

    Oneness Biotech Co., Ltd

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chih-Hsin Lee Division of Thoracic Medicine
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shu-Min Lin Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Han-Pin Kuo Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen Chia-Hung Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jia-Yih Feng Division of Infectious Disease
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HAO-CHIEN WANG Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pin-Kuei Fu Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴建豪 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭世隆 Division of Thoracic Medicine
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 柯政昌 Division of Thoracic Medicine
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林裕清 Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Xin-Min Liao Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 沈聲燁 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 沈聲燁 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 彭忠衎 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Allergic Asthma

Objectives

Primary Objective  To evaluate the clinical efficacy of FB825 in preventing exacerbation in patients with moderate-to-severe allergic asthma Secondary Objectives  To evaluate the immunogenicity of FB825 in patients with moderate-to-severe allergic asthma  To assess the effects of FB825 on asthma-specific health-related quality-of-life  To evaluate the effects of FB825 on asthma symptoms in patients with moderate-to-severe allergic asthma (including asthma exacerbation)  To evaluate the pharmacokinetic profiles of FB825 in patients with moderate-to-severe allergic asthma  To evaluate safety and tolerability of FB825 in patients with moderate-to-severe allergic asthma  To evaluate effects of FB825 on biomarkers in patients with moderate-to-severe allergic asthma, including total IgE, allergen-specific IgE, eosinophil counts (Blood), exhaled NO, WBC count (absolute and percentage), mIgE B cell counts (absolute and percentage), and cytokines such as thymus and activation-regulated chemokine (TARC), eotaxin-3, and periostin in patients

Test Drug

FB825

Active Ingredient

Humanized Anti-CεmX Monoclonal Antibody

Dosage Form

Vial

Dosage

20 mg

Endpoints

Primary Endpoints
 Occurrence of an exacerbation of asthma at week 24
Exacerbation of asthma as defined by any of the following:
- A 30% or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days, or
- ≥6 additional reliever puffs of albuterol (or equivalents) in a 24 hour period (compared to baseline) on 2 consecutive days or
- Deterioration of asthma, as determined by the investigator, requiring:
 Systemic (oral and/or parenteral) steroid treatment, or
 An increase of ICS usage by ≥4 times of the protocol-defined dose (refer to 5.1.3 background therapy table) at each phase throughout the study period, or
 Hospitalization, or
 ER (emergency room visit) due to asthma attack

Secondary Endpoints
 Mean change in morning peak expiratory flow (PEF) from baseline to week 12, 16, and 24.
 Change in ACQ-5 from baseline to week 12, 16, and 24.
 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).
 Change in FEV1 from baseline to week 12, 16, and 24.
 Occurrence of an exacerbation of asthma at week 12 and 16.
Exacerbation of asthma as defined by any of the following:
- A 30% or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days, or
- ≥6 additional reliever puffs of albuterol (or equivalents) in a 24 hour period (compared to baseline) on 2 consecutive days or
- Deterioration of asthma, as determined by the investigator, requiring:
 Systemic (oral and/or parenteral) steroid treatment, or
 An increase of ICS usage by ≥4 times of the protocol-defined dose (refer to 5.1.3 background therapy table) at each phase throughout the study period , or
 Hospitalization, or
 ER (emergency room visit) due to asthma attack.
 The incidence of treatment-emergent adverse events throughout the study.
 The PK and anti-FB825 antibody characterization of FB825 during the study.

Inclution Criteria

1. Male or females 18–75 years old.
2. Subjects diagnosed with moderate-to-severe allergic asthma [Global Initiative for
Asthma [GINA]; GINA, 2019) at least 12 months prior to Visit 1 and post-BD
reversibility of FEV1 ≥ 12% and ≥ 200 mL during screening.
3. Documented reversibility from historical data within 5 years of Visit 1 of at least 12%
and 200 mL in FEV1 after the administration of 200 to 400 mcg albuterol/salbutamol
(2 to 4 inhalations of albuterol/salbutamol or of a nebulized solution of
albuterol/salbutamol, if considered as a standard office practice) OR documented
airway hyperresponsiveness (methacholine PC20 < 8 mg/mL [or PC20 < 16 mg/mL on
ICS]) within 5 years of Visit 1. Reversibility should be documented. If reversibility
data is not available, the bronchodilator test should be finished before randomization.
4. Subjects must have a morning pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80%
predicted at screening
5. 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.
a. High-dose ICS is defined as total daily dose of >500 mcg fluticasone propionate or
equivalent.
b. Medium-dose ICS is defined as a total daily dose of 250 to 500 mcg fluticasone
propionate or equivalent.
c. Equivalence ICS doses will be based upon the GINA guidelines (GINA, 2019),
shown in Appendix 12.1
d. 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 entry of study.
6. 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® -160/9 μg BID or 320/9
μg BID), or
 Mometasone/formoterol combination therapy (Dulera® -200/10 μg BID or 400/10
μg BID)
7. Subjects must have a documented history of protocol-defined severe asthma
exacerbation at least 1 or more times within the 12 months.
8. A total serum IgE ≥ 400 IU/mL
9. Subjects must have at least one positive in skin prick test or at least one environmental
allergen-specific IgE greater than normal range.
10. 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
11. 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.
12. 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.
13. The subject has a body weight ≥ 40 kg at screening.
14. The subject has a normal, as determined by the investigator, 12-lead electrocardiogram
(ECG).
15. The subject is able to provide written informed consent.
16. The subject agrees to comply with all protocol requirements.

Exclusion Criteria

1. 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.
2. >20% relative change in FEV1 between screening and randomization
3. Female subjects who are pregnant or lactating.
4. 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
5. Patients with positive HBeAg results should be excluded as it is an indication of active
Hepatitis B virus replication.
6. Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease) other
than allergic asthma.
7. Use of any experimental drug within 30 days or 5 half-lives, whichever is longer, prior
to or during the screening period.
8. 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.
9. Current or history of treatment with anti-IgE antibody treatment within 6 months or 5
half-lives, whichever is longer.
10. 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.
11. 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.
12. 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.
13. The subject has severe kidney disease, defined as estimated GFR<30ml/min/1.73m2
or
creatinine > 3x ULN.
14. The subject has known or suspected history of immunosuppression or
immunodeficiency.
15. 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.
16. 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.
17. 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.
18. 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.
19. The subject has received live vaccine within 12 weeks prior to dosing or planned live
attenuated vaccinations during the study.
20. The subject has a history of any clinically relevant arrhythmias as determined by the
investigator.
21. 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.
22. History of anaphylaxis to any biologic therapy.
23. 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.
24. The subject has comorbid disease that might interfere with the evaluation of
IMP(investigational medicinal product) or conduct of study procedures (eg,
bronchodilator test).
25. 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.
26. 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
27. 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.
28. Use of Tradtional Chinese Medications in the treatment of asthma within 3 months
prior to screening. (To be listed in Prohibited Medications)
29. Aggravating factors that are inadequately controlled e.g., medication uncontrolled
gastroesophageal reflux disease.
30. 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.

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    0 participants

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