Asthma
Conditions
Brief summary
This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 weeks and follow-up period of 8 weeks.
Interventions
DRUG610
Subcutaneously injection.
DRUGPlacebo
Subcutaneously injection.
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study. * 2\. Female and male aged 18 to 75 years. * 3\. Diagnosed with asthma for ≥12 months that meet GINA. * 4\. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening. * 5\. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening. * 6\. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.
Exclusion criteria
* 1\. Presence of a known pre-existing, clinically important lung condition other than Asthma. * 2\. Severe asthma exacerbation within 4 weeks prior to randomization. * 3\. Subjects with any eosinophilic diseases other than asthma. * 4\. Known, pre-existing severe or clinically significant cardiovascular disease. * 5\. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment. * 6\. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. * 7\. Subjects with allergy/intolerance to a monoclonal antibody.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52 | Baseline (Day 1) and at week 52 | FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16 | Baseline (Day 1) and at week 16 | FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. |
| Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12,16, 20, 28, 36, 44, 52 | Baseline (Day 1) and at week 4, 8,12,16, 20, 28, 36, 44, 52 | Percentage of FEV1 will be measured using spirometry. |
| Number of asthma exacerbation through study week 52 | From baseline (Day 1) to week 52 | Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period |
| Number of asthma exacerbations requiring hospitalization or emergency room visits | From baseline (Day 1) to week 52 | Asthma exacerbations that are associated with a hospitalization or an emergency room visit. |
| Change from baseline in Asthma Control Questionnaire (ACQ) score. | From baseline (Day 1) to week 52 | The ACQ contains five symptom questions (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze), one bronchodilator question and pre-bronchodilator FEV1 level. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ score is the average of the responses. Higher score indicates more limitations. |
| Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) | From baseline (Day 1) to week 52 | The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best. |
| Assessment of adverse events (AEs) | Up to week 60 | Number of participants with adverse events (AEs) |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMin Zhang, Doctor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed