Evaluating a new treatment for severe asthma in adults

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 study is testing a new treatment for severe asthma in adults to see if it can improve their lung function and reduce symptoms compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Oneness Biotech Co., Ltd. (Industry-sponsored)
• Locations: 9 sites (Hsinchu and 8 other locations)
• Trial ID: NCT05018299 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, placebo-controlled, double-blind study designed to assess the safety, tolerability, pharmacokinetics, and clinical efficacy of FB704A in adults diagnosed with severe asthma. Approximately 40 participants will be enrolled and randomly assigned to receive either FB704A or a placebo over an 8-week treatment period following a 4-week screening phase. The study will involve administering the treatment via a 1-hour intravenous infusion and will include multiple site visits for monitoring efficacy and safety outcomes. Key measures will include changes in lung function and asthma symptoms throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a documented diagnosis of severe asthma and specific clinical characteristics as outlined in the eligibility criteria.

Not a fit: Patients with mild or moderate asthma, or those who have had a severe asthma exacerbation within the last 4 weeks, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve asthma control and quality of life for patients with severe asthma.

How similar studies have performed: Other studies have shown promise with similar approaches in treating severe asthma, indicating potential for success with this novel treatment.

Eligibility criteria

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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) 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.

Where this trial is running

Hsinchu and 8 other locations

• 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)

Study contacts

• Study coordinator: Jessica Ho, Director

Conditions Severe Asthma; Asthma