Evaluation of 611 in Chinese Adults Patients With Moderat... | NCT07039669

NCT07039669

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
611	Experimental	611 Q2W, subcutaneous (SC) injection	Drug: 611
placebo	Placebo Comparator	placebo Q2W, subcutaneous (SC) injection	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
611	Drug	611 subcutaneous (SC) injection	611
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Annualized 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.	Baseline to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in pre-bronchodilator FEV1 at Week 24	FEV1 is the Forced expiratory volume in one second at study site	Baseline, Week 24
Time to first Moderate or severe COPD exacerbation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
Male or female adults ages 40 to 85 years old when signing the informed consent.
Current or former smokers with a smoking history of ≥10 pack-years.
Documented diagnosis of COPD for at least 12 months prior to enrolment
Moderate-to-severe COPD.
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥ 1 month prior to randomization; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.

Exclusion Criteria:

Presence of a known pre-existing, clinically important lung condition other than COPD.
A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
Diagnosis of α-1 anti-trypsin deficiency.
Presence of an active autoimmune disease.
Subjects who have any malignant tumors within 5 years prior to enrollment.
Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled.
Diagnosed active parasitic infection, suspected or high risk of parasitic infection.
Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
Known with allergic or intolerant to any biological product.
Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

ID	Term
D008171	Lung Diseases
D029424	Pulmonary Disease, Chronic Obstructive