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

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

Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT07039669) is a Phase 3 interventional studying Pulmonary Disease, Chronic Obstructive (COPD), sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Pulmonary Disease, Chronic Obstructive (COPD), Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 594 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to understand and follow the protocol requirements, and give written willing to sign a consent form prior to participation voluntarily in the study. 2. Male or female adults ages 40 to 85 years old when signing the willing to sign a consent form. 3. Current or former smokers with a smoking history of ≥10 pack-years. 4. Documented diagnosis of COPD for at least 12 months prior to enrolment 5. Moderate-to-severe COPD. 6. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment. 7. 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. 8. 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. Who Should NOT Join This Trial: 1. Presence of a known pre-existing, clinically important lung condition other than COPD. 2. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. 3. Diagnosis of α-1 anti-trypsin deficiency. 4. Presence of an active autoimmune conditions (where your immune system attacks your own body). 5. Subjects who have any malignant tumors within 5 years prior to enrollment. 6. Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled. 7. Diagnosed active parasitic infection, suspected or high risk of parasitic infection. 8. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study. 2. Male or female adults ages 40 to 85 years old when signing the informed consent. 3. Current or former smokers with a smoking history of ≥10 pack-years. 4. Documented diagnosis of COPD for at least 12 months prior to enrolment 5. Moderate-to-severe COPD. 6. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment. 7. 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. 8. 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: 1. Presence of a known pre-existing, clinically important lung condition other than COPD. 2. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. 3. Diagnosis of α-1 anti-trypsin deficiency. 4. Presence of an active autoimmune disease. 5. Subjects who have any malignant tumors within 5 years prior to enrollment. 6. Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled. 7. Diagnosed active parasitic infection, suspected or high risk of parasitic infection. 8. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. 9. Known with allergic or intolerant to any biological product. 10. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

Treatments Being Tested

DRUG

611

611 subcutaneous (SC) injection

DRUG

Placebo

placebo Q2W, subcutaneous (SC) injection

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

ZheJiang Provincial People's Hospital

Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07039669), the sponsor (Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07039669 clinical trial studying?

The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07039669?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07039669?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07039669. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07039669. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.