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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | 611 300 mg Q2W, subcutaneous (SC) injection |
|
| group B | Experimental | 611 450 mg Q2W, subcutaneous (SC) injection |
|
| placebo group | Placebo Comparator | placebo Q2W, subcutaneous (SC) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 611 300 mg Q2W | Drug | 611 subcutaneous (SC) injection |
| |
| 611 450 mg Q2W |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pre-bronchodilator FEV1 at Week 16 | FEV1 is the Forced expiratory volume in one second at study site | up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to Week 16 |
| Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China | ||
| Shenzhen People's Hospital |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C071192 | entacapone |
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| Drug |
611 subcutaneous (SC) injection |
|
| Matching placebo | Drug | placebo subcutaneous (SC) injection |
|
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. |
| 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. | 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 | 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 | 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. | Up to 24 Weeks |
| 611 Concentration in Serum | The concentration of 611 in Serum | 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%. | 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 | Up to 24 Weeks |
| Shenzhen |
| Guangdong |
| 518020 |
| China |
| Zhongshan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |