- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05018299
Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately 40 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. There are 20 subjects participate in each 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Joanna Hung, MS
- Phone Number: 594 +886 2 2703 1098
- Email: joanna.hung@onenessbio.com.tw
Study Contact Backup
- Name: NienYi Chen, PhD
- Phone Number: 563 +886 2 2655 8687
- Email: nienyichen@onenessbio.com.tw
Study Locations
-
-
-
Hsinchu, Taiwan
- Recruiting
- NTUH Hsin-Chu Branch
-
Contact:
- Jen-Chang Ko, MD, PhD
-
Principal Investigator:
- Jen-Chang Ko, MD, PhD
-
Taichung, Taiwan
- Active, not recruiting
- Taichung Veterans General Hospital
-
Taichung city, Taiwan
- Recruiting
- China Medical University Hospital
-
Contact:
- Chia-Hung Chen
-
Principal Investigator:
- Chia-Hung Chen, MD
-
Taipei, Taiwan
- Recruiting
- Taipei Medical University Hospital
-
Principal Investigator:
- Han-Pin Kuo
-
Contact:
- Han-Pin Kuo, MD, PhD
-
Taipei, Taiwan
- Recruiting
- Taipei Veterans General Hospital
-
Principal Investigator:
- Hsin-Kuo Ko, MD, PhD
-
Contact:
- Ru-Min Huang
-
Taipei, Taiwan
- Recruiting
- Ministry of Health and Welfare Shuang-Ho Hospital
-
Principal Investigator:
- Tzu-Tao Chen, MD, PhD
-
Contact:
- Avan Li
-
Contact:
- Yi-Hsuan Chen
-
Taipei, Taiwan
- Recruiting
- Taipei Municipal Wanfang Hospital
-
Contact:
- Yu-Chieh Wu
-
Principal Investigator:
- Chih-Hsin Lee, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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), and have at least one of the following:≧12% and/or 200 mL improvement in Forced Expiratory Volume in 1 second (FEV1) post-bronchodilator, and/or airway hyperresponsiveness (eg, positive methacholine challenge <8 mg/mL).
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 <3000/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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: FB704A placebo
placebo
|
Placebo
|
Experimental: FB704A
Anti-IL6 antibody
|
Anti-IL-6 antibody
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of the number of Adverse Event reported during the treatment period
Time Frame: Day 57
|
AE
|
Day 57
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: week 4, 8, 12, and 20
|
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.
|
week 4, 8, 12, and 20
|
Change from baseline in blood neutrophil counts
Time Frame: Day 36, 57, 85, 113, and 141
|
neutrophil counts
|
Day 36, 57, 85, 113, and 141
|
Change from baseline in sputum neutrophil counts
Time Frame: Day 57
|
neutrophil counts
|
Day 57
|
ACT score
Time Frame: Day 36, 57, 85, and 141
|
The ACT Score > 19 means well controlled.
|
Day 36, 57, 85, and 141
|
Change from baseline in Asthma control test (ACT)
Time Frame: Day 36, 57, 85, and 141
|
The ACT Score > 19 means well controlled.
|
Day 36, 57, 85, and 141
|
Change from baseline in ACQ-5
Time Frame: Day 36, 57, 85, and 141
|
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.
|
Day 36, 57, 85, and 141
|
Change from baseline in AQLQ
Time Frame: Day 36, 57, 85, and 141
|
Standardized Asthma Quality of Life Questionnaire (AQLQ) will be applied to evaluate the asthma specific quality of life.
|
Day 36, 57, 85, and 141
|
Change from baseline in pre-bronchodilator FEV1 , post-bronchodilator FEV1, exhaled NO and asthma symptoms
Time Frame: Day 57 and 141
|
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
|
Day 57 and 141
|
Proportion of the number of AE reporting (incidence of adverse event)
Time Frame: 12 weeks follow up
|
AE
|
12 weeks follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in IL-6
Time Frame: during the study (8 weeks treatment period and 12 weeks follow up
|
IL-6
|
during the study (8 weeks treatment period and 12 weeks follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: NienYi Chen, PhD, Oneness Biotech
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FB704ACLIS-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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