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Severe AsthmaPhase 2NCT05018299

Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma

A Phase 2 study testing FB704A in people with Severe Asthma, run by Oneness Biotech Co., Ltd. at 7 sites 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 a randomized, placebo controlled and double blind study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FB704A in adult patients with severe asthma. The study comprised a 4-week screening period, a 8-week treatment period and a 12-week follow-up period. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Severe Asthma
What is being tested?
FB704A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
7 sitesTaiwan
Study dates
30 Sep 2021to 8 May 2026
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.18 to ≦75 years of age, either sex, any race.
  • 2.Diagnosed as severe asthma based on 2020 GINA guideline.
  • 3.An ACT score is <20.
  • 4.Induced sputum neutrophil count ≧50% of total sputum cells during Screening.
  • 5.Documented diagnosis of severe asthma within past 5 years. Additionally, subjects must have at least one of the following: a) ≧12% and/or 200 mL improvement in Forced Expiratory Volume in 1 second (FEV1) post-bronchodilator, OR b) airway hyperresponsiveness (e.g., positive methacholine challenge <8 mg/mL), OR c) within the past 24 months, airway variability with a ≧12% and 200 mL change in FEV1 between clinic visits outside of respiratory infections, documented prior to Visit 1, OR d) within the past 24 months, average daily PEF variability > 10% over a 2-week period, documented prior to Visit 1.
  • 6.Nonsmoker or previous smoker with cumulative smoking history less than 10 pack-years (pack-year = 20 cigarettes smoked daily for 1 year). Previous smokers may not have smoked within 1 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.
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  • 7.Must not have had a severe asthma exacerbation of asthma for 4 weeks prior to Screening and must be on a stable medication regimen for asthma at least 4 weeks prior to Screening.
  • A Severe asthma exacerbation is defined as a deterioration of asthma leading to treatment for 3 days or more with systemic glucocorticoids or hospitalization or an emergency department visit leading to treatment with systemic glucocorticoids.
  • 8.Must be willing to give written informed consent to participate in the study.
  • 9.Must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction.
  • 10.Female subject of childbearing potential must have a negative serum pregnancy test at Screening and must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. Female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.
  • Male subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women who use a highly effective birth control method.

Who cannot join

  • 1.Chronic Obstructive Pulmonary Disease (COPD)/other relevant lung disease (other than asthma)
  • 2.4 weeks prior to/or Screening: upper/lower respiratory tract infection
  • 3.Screening: Inadequate amount or difficulty producing sputum
  • 4.Screening: Sputum neutrophil count over 10 million/mL
  • 5.Screening: peripheral blood neutrophil (PBN) count <2000/µL
  • 6.Clinically significant chronic infectious disease(s) (eg, Human Immunodeficiency Virus [HIV], hepatitis B or C)
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  • 7.Allergy/sensitivity to study drug/excipients
  • 8.Breast-feeding, pregnant/intends to become pregnant during study
  • 9.Requiring mechanical ventilation for respiratory event within 6 months of Screening
  • 10.Medical condition(s) (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic) or medication that may interfere with effect of study medication
  • 11.Within 30 days of Screening: any other investigational drug
  • 12.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
  • 13.Active infection, including opportunistic infections, requiring systemic therapy within the past 2 weeks
  • 14.A deep space infection within the past 2 years (including, but not limited to meningitis, epiglottitis, endocarditis, septic arthritis, fasciitis, abdominal or pleural abscess, or osteomyelitis)
  • 15.History of diverticulitis, diverticulosis requiring antibiotic treatment, or other symptomatic lower gastrointestinal (GI) conditions that might predispose to perforations
  • 16.Immunization with a live/attenuated vaccine within 4 weeks prior to treatment
  • 17.Evidence of active malignant disease, malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured)
  • 18.Liver enzymes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3x upper limit of normal
  • 19.Serum bilirubin > 2x upper limit of normal
  • 20.Low platelet count (<100,000/mm3)
  • 21.Dyslipidemia.
  • 22.Participation in any other clinical study.
  • 23.Part of the staff personnel involved with the study.
  • 24.Family member of investigational study staff.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Taiwan7 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei

  • Taipei Medical University Hospital

    Taipei

  • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

    Taipei

  • Taipei Municipal Wanfang Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: A Randomized, Placebo Controlled, Double Blind Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Multiple Intravenous Doses of FB704A in Adults With Severe Asthma

This is a randomized, placebo controlled and double blind study to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FB704A in adult patients with severe asthma. The study comprised a 4-week screening period, a 8-week treatment period and a 12-week follow-up period.

Read the detailed description

Approximately 20 subjects who meet the criteria for study entry are planned to be enrolled to the study. Eligible subjects will be randomized to receive placebo or FB704A in a 1:1 ratio, with an estimated 10 subjects per treatment arm.

Eligibility will be checked in patients with severe asthma during the 4-week screening period. Potential candidates should provide signed informed consent forms before starting the screening activities. The subjects will receive four dose of 4 mg/kg FB704A or placebo. The study drug will be administered as a 1-hour IV infusion.

Patients may administer Short-acting beta agonists (SABAs), such as albuterol as rescue medications as needed throughout the study.

Subjects will have site visits after receiving study drug for efficacy, safety, PK, and biomarker evaluation (see Study Flow Chart). Subjects who prematurely withdraw from the study will have an end of study (EOS) visit within 7 days.

Relative change in pre-bronchodilator FEV 1 , post-bronchodilator FEV 1, exhaled NO and asthma symptom s will be evaluated during the study.

Conditions
Severe Asthma
Being tested
FB704A placebo, FB704A
Keywords
Asthma
Medical subject headings
Asthma

What participants receive

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

  • FB704A placeboBiological

    Placebo

  • FB704ABiological

    Anti-IL-6 antibody

Study groups in NCT05018299
Study groupRoleWhat they receive
FB704A placeboPlacebo comparatorplacebo
Receives: Biological: FB704A placebo
FB704AExperimentalAnti-IL6 antibody
Receives: Biological: FB704A

What is being measured

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

  1. Proportion of the number of Adverse Event reported during the treatment period

    AE

    Measured: Day 57

Secondary outcomes (9)

  1. Change from baseline in blood neutrophil counts

    neutrophil counts

    Measured: Day 36, 57, 85, 113, and 141

  2. Change from baseline in sputum neutrophil counts

    neutrophil counts

    Measured: Day 57

  3. ACT score

    The ACT Score > 19 means well controlled.

    Measured: Day 36, 57, 85, and 141

  4. Change from baseline in Asthma control test (ACT)

    The ACT Score > 19 means well controlled.

    Measured: Day 36, 57, 85, and 141

  5. Percentage of patients achieving decrease in score by greater than or equal to 0.5 points on the ACQ 5 (with a minimal importance difference improvement)

    The Asthma symptom score and 5 item Asthma Control Questionnaire (ACQ 5) will be applied to evaluate the condition of asthma control. Subjects will perform the test.

    Measured: week 4, 8, 12, and 20

  6. Change from baseline in ACQ-5

    The Asthma symptom score and 5 item Asthma Control Questionnaire (ACQ 5) will be applied to evaluate the condition of asthma control. Subjects will perform the test.

    Measured: Day 36, 57, 85, and 141

  7. Change from baseline in AQLQ

    Standardized Asthma Quality of Life Questionnaire (AQLQ) will be applied to evaluate the asthma specific quality of life.

    Measured: Day 36, 57, 85, and 141

  8. Change from baseline in pre-bronchodilator FEV1 , post-bronchodilator FEV1, exhaled NO and asthma symptoms

    Forced expiratory volume in 1 second (FEV1) is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Spirometry testing must be performed in the morning between 6 11 am according to the schedule of study procedures. After the first screening spirometry completed, the

    Measured: Day 57 and 141

  9. Proportion of the number of AE reporting (incidence of adverse event)

    AE

    Measured: 12 weeks follow up

Timeline

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

  1. First posted24 Aug 2021
  2. Study start30 Sep 2021
  3. Primary completion8 May 2026
  4. Study completion8 May 2026

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
Double blind
Who is masked
Participant, Investigator
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018299
Sponsor's protocol ID
FB704ACLIS-02
Status last verified
Dec 2025
First submitted
15 Aug 2021
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FB704A in people with Severe Asthma, run by Oneness Biotech Co., Ltd. at 7 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 12 inclusion and 24 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

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?

Proportion of the number of Adverse Event reported during the treatment period (time frame: Day 57). 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 NCT05018299.

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 9 Jul 2026.

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