Actively Recruiting
Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma
Led by Oneness Biotech Co., Ltd. · Updated on 2025-12-09
20
Participants Needed
9
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years, any gender or race
- Diagnosed with severe asthma according to 2020 GINA guidelines
- Asthma Control Test (ACT) score below 20
- Induced sputum neutrophil count of 50% or more during screening
- Documented severe asthma diagnosis within the past 5 years
- At least one of the following lung function or airway responsiveness criteria: 12% and/or 200 mL improvement in FEV1 post-bronchodilator, airway hyperresponsiveness, recent airway variability, or peak expiratory flow variability
- Non-smoker or former smoker with less than 10 pack-years, not smoked within 1 year before screening
- No severe asthma exacerbation in the 4 weeks before screening and stable asthma medication for at least 4 weeks
- Willing to provide written informed consent
- Able to comply with dosing, visits, and sputum induction
- Females of childbearing potential must have a negative pregnancy test and use effective birth control during screening and treatment
- Females not of childbearing potential must be surgically sterile or postmenopausal
- Males must agree to use contraception and have sexual relations only with partners using effective birth control
You will not qualify if you...
- Chronic obstructive pulmonary disease or other lung diseases besides asthma
- Respiratory tract infection within 4 weeks before or during screening
- Inadequate or difficult sputum production at screening
- Sputum neutrophil count over 10 million/mL at screening
- Peripheral blood neutrophil count below 2000/µL
- Significant chronic infectious diseases such as HIV or hepatitis B/C
- Allergy or sensitivity to study drug or its ingredients
- Pregnant, breastfeeding, or planning pregnancy during the study
- Mechanical ventilation for respiratory issues within 6 months before screening
- Medical conditions or medications that could interfere with study drug effects
- Use of other investigational drugs within 30 days before screening
- History or evidence of active tuberculosis
- Active infections requiring systemic therapy within 2 weeks before screening
- Deep space infections within the past 2 years
- History of diverticulitis or other GI conditions increasing risk of perforations
- Live or attenuated vaccine within 4 weeks before treatment
- Active cancer diagnosed within 5 years except certain skin or cervical cancers
- Liver enzyme levels over 3 times normal limits or bilirubin over twice normal
- Low platelet count below 100,000/mm3
- Dyslipidemia
- Participation in another clinical study
- Staff involved in the study or their family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
NTUH Hsin-Chu Branch
Hsinchu, Taiwan
Withdrawn
2
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
3
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
4
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
5
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
6
Taipei Medical University Hospital
Taipei, Taiwan
Actively Recruiting
7
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
Taipei, Taiwan
Actively Recruiting
8
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Actively Recruiting
9
Taipei Veterans General Hospital
Taipei, Taiwan
Withdrawn
Research Team
J
Jessica Ho, Director
CONTACT
S
Sophie Weng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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