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

NCT05018299 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FB704ACLIS-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Severe Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Proportion of the number of Adverse Event reported during the treatment period

  AE

  Day 57

Secondary Outcomes (9)

• Change from baseline in blood neutrophil counts

  Day 36, 57, 85, 113, and 141

• Change from baseline in sputum neutrophil counts

  Day 57

• ACT score

  Day 36, 57, 85, and 141

• Change from baseline in Asthma control test (ACT)

  Day 36, 57, 85, and 141

• 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)

  week 4, 8, 12, and 20

Other Outcomes (1)

• Change in IL-6

  during the study (8 weeks treatment period and 12 weeks follow up

Study Arms (2)

FB704A placebo

PLACEBO COMPARATOR

placebo

Biological: FB704A placebo

FB704A

EXPERIMENTAL

Anti-IL6 antibody

Biological: FB704A

Interventions

FB704A placebo BIOLOGICAL

Placebo

FB704A placebo

FB704A BIOLOGICAL

Anti-IL-6 antibody

FB704A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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) 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.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (9)

NTUH Hsin-Chu Branch

Hsinchu, Taiwan

WITHDRAWN

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

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

Taipei, Taiwan

RECRUITING

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

WITHDRAWN

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jessica Ho, Director

  Oneness Biotech

  STUDY DIRECTOR

Central Study Contacts

Jessica Ho, Director

CONTACT

+886 2 2655 8098; jessica.ho@onenessbio.com.tw

Sophie Weng

CONTACT

+886 2 2655 8098; sophie.weng@onenessbio.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 24, 2021
• Study Start: September 30, 2021
• Primary Completion: February 13, 2026
• Study Completion (Estimated): May 8, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

TW (9)