Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Ki vehet részt

• 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

Ki nem vehet részt

• Subjects who have any malignant tumors within 5 years prior to enrollment
• Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled
• 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
• Presence of an active autoimmune disease
• 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
• Diagnosis of α-1 anti-trypsin deficiency
• Any reason which, in the opinion of investigator, would prevent the subject from participating in the study