The primary 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 28 weeks per participants, including a screening period of up to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
611 subcutaneous (SC) injection
611 subcutaneous (SC) injection
placebo subcutaneous (SC) injection
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Change from baseline in pre-bronchodilator FEV1 at Week 16
FEV1 is the Forced expiratory volume in one second at study site
Time frame: up to Week 16
Change from baseline in Chronic Obstructive Pulmonary Disease assessment tool (CAT) score
Chronic Obstructive Pulmonary Disease assessment tool (CAT) score ranges from 0 to 40, a higher score indicating a higher impact on health status.
Time frame: up to Week 16
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
St. George's Respiratory Questionnaire (SGRQ) is a questionnaire designed to measure and quantify health-related health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100. Lower score indicates better quality of life.
Time frame: up to Week 16
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16
St. George's Respiratory Questionnaire (SGRQ) is a questionnaire designed to measure and quantify health-related health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100. Lower score indicates better quality of life.
Time frame: up to Week 16
Annualized rate of moderate to severe COPD exacerbations in participants
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD. Moderate:Use of systemic corticosteroids; and/or use of antibiotics; Severe:An inpatient hospitalization due to COPD
Time frame: up to Week 16
Time to first Moderate or severe COPD exacerbation
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD. Moderate:Use of systemic corticosteroids; and/or use of antibiotics; Severe:An inpatient hospitalization due to COPD
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Time frame: up to Week 16
Adverse events (AEs), measurement of vital signs,physical examination,electrocardiogram and laboratory tests at each visit.
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations,electrocardiogram,laboratory tests and, etc.
Time frame: Up to 24 Weeks
611 Concentration in Serum
The concentration of 611 in Serum
Time frame: Up to 24 Weeks
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: Up to 24 Weeks
Change in serum concentrations of PD variables
PD variables included Pulmonary and activation-regulated chemokine (PARC),IgE,blood eosinophil counts and fibrinogen
Time frame: Up to 24 Weeks