The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
The maximum study duration was 66 weeks per participants, including a screening period of up to 6 weeks, a 52-week randomized treatment period, and a 8-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
594
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGAnnualized rate of moderate or severe COPD Exacerbations
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required systemic corticosteroids with/without antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death.
Time frame: Baseline to Week 52
Change from baseline in pre-bronchodilator FEV1 at Week 24
FEV1 is the Forced expiratory volume in one second at study site
Time frame: Baseline, Week 24
Time to first Moderate or severe COPD exacerbation
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required systemic corticosteroids with/without antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death.
Time frame: Baseline to Week 52
Annualized rate of severe COPD Exacerbations
Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death.
Time frame: Baseline to Week 52
Change from baseline in pre-bronchodilator FEV1
FEV1 is the Forced expiratory volume in one second at study site
Time frame: Baseline to Week 52
Change from baseline in SGRQ scores
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ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGSt. George's Respiratory Questionnaire (SGRQ).The SGRQ is a 50-item self-administered questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Total score was obtained by summing all positive responses in the questionnaire. The minimum and maximum values were 0 and 100, respectively. Higher scores mean a worse outcome. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
Time frame: Baseline to Week 52
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline
Time frame: Baseline to Week 16
Change from baseline in post-bronchodilator FEV1
FEV1 is the Forced expiratory volume in one second at study site
Time frame: Baseline to Week 52
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed or worsened or became serious during TE period (between the first administration of study treatment to the last administration of the study treatment + 14 days).
Time frame: Up to 60 Weeks
611 Concentration in Serum
The concentration of 611 in Serum
Time frame: Baseline to Week 60
Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies
Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants \* 100%
Time frame: Baseline to Week 60
Change in serum concentrations of Pulmonary and activation-regulated chemokine (PARC)
Change in serum concentrations of PARC
Time frame: Baseline to Week 60
Change in serum concentrations of IgE
Change in serum concentrations of IgE
Time frame: Baseline to Week 60