Actively Recruiting
Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Led by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Updated on 2025-11-18
594
Participants Needed
4
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
CONDITIONS
Official Title
Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow the protocol requirements and give written informed consent voluntarily
- Male or female adults aged 40 to 85 years
- Current or former smokers with a history of at least 10 pack-years
- Documented diagnosis of COPD for at least 12 months before enrollment
- Moderate to severe COPD
- History of 2 or more moderate or 1 or more severe COPD exacerbations within the past 12 months
- Receiving stable background triple therapy (ICS + LABA + LAMA) for at least 3 months, with stable dose for at least 1 month; double therapy (LABA + LAMA) allowed if ICS contraindicated
- Use of highly effective contraception for females of reproductive age and their male partners, and for males and their female partners during the study and for 3 months after last dose, with no plans for pregnancy or sperm/egg donation
You will not qualify if you...
- Presence of other clinically significant lung conditions besides COPD
- Current diagnosis or history of asthma
- Diagnosis of alpha-1 antitrypsin deficiency
- Active autoimmune disease
- Malignant tumors within 5 years prior to enrollment
- Other uncontrolled significant medical conditions
- Diagnosed active parasitic infection or high risk for it
- Active Hepatitis B, Hepatitis C, or HIV infections
- Known allergy or intolerance to any biological product
- Any other reason deemed by the investigator to prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Not Yet Recruiting
2
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
3
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 212028
Actively Recruiting
4
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
Research Team
Q
Qinghong Zhou, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here