Testing drug 611 against placebo for chronic lung disease in China
Compares drug 611 with placebo in adults with moderate to severe COPD.
Plain-language title generated from the registry record
Registry title: Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Key facts
- Where
- Beijing, Hangzhou, Nanjing, and Shenzhen, ChinaSee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Source: NCT07039669, who can take part
Where in China
- China-Japan Friendship HospitalBeijing, ChinaNot yet recruiting
- Zhejiang Provincial People's HospitalHangzhou, ChinaNot yet recruiting
- Jiangsu Province HospitalNanjing, ChinaTaking people
- Shenzhen People's HospitalShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Trial code
- NCT07039669
- Record updated
- 18 November 2025
- Original description
The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.Read full original descriptionShow less
A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease
The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
Inclusion: 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: 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.