Pulmonary Disease, Chronic Obstructive (COPD)Phase 3NCT07039669
Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 3 study testing 611 in people with Pulmonary Disease, Chronic Obstructive (COPD), run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 4 sites in China.
Trial summary
The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive (COPD)
- What is being tested?
- 611
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 594 participants
- Where
- 4 sitesChina
- Study dates
- 16 Jul 2025to Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Ting Yang, Master, +8613651380809, dryangting@qq.com
Ting Yang, Master
- Not yet recruiting
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Yilan Sun, +8613858188066, 13858188066@126.com
Yilan Sun
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 212028
Xin Yao, +8618651608881, xyao1998@126.com
Xin Yao
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Rongchang Chen, Master, +8613902273260, chenrc@vip.163.com
Rongchang Chen, Master
About this study
Official title: 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.
Read the detailed description
The maximum study duration was 66 weeks per participants, including a screening period of up to 6 weeks, a 52-week randomized treatment period, and a 8-week follow-up period.
- Being tested
- 611, Placebo
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
611Drug
611 subcutaneous (SC) injection
PlaceboDrug
placebo Q2W, subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| 611 | Experimental | 611 Q2W, subcutaneous (SC) injection Receives: Drug: 611 |
| placebo | Placebo comparator | placebo Q2W, subcutaneous (SC) injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 52
Secondary outcomes (12)
Change from baseline in pre-bronchodilator FEV1 at Week 24
FEV1 is the Forced expiratory volume in one second at study site
Measured: Baseline, Week 24
Time to first Moderate or severe COPD exacerbation
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.
Measured: Baseline to Week 52
Annualized rate of severe COPD Exacerbations
Severe exacerbations were 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.
Measured: Baseline to Week 52
Change from baseline in pre-bronchodilator FEV1
FEV1 is the Forced expiratory volume in one second at study site
Measured: Baseline to Week 52
Change from baseline in SGRQ scores
St. George's Respiratory Questionnaire (SGRQ).The SGRQ is a 50-item self-administered questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Total score was obtained by summing all positive responses in the questionnaire. The minimum and maximum values were 0 and 100, respectively. Higher scores mean a worse outcome. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
Measured: Baseline to Week 52
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline
Measured: Baseline to Week 16
Change from baseline in post-bronchodilator FEV1
FEV1 is the Forced expiratory volume in one second at study site
Measured: Baseline to Week 52
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed or worsened or became serious during TE period (between the first administration of study treatment to the last administration of the study treatment + 14 days).
Measured: Up to 60 Weeks
611 Concentration in Serum
The concentration of 611 in Serum
Measured: Baseline to Week 60
Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies
Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%
Measured: Baseline to Week 60
Change in serum concentrations of Pulmonary and activation-regulated chemokine (PARC)
Change in serum concentrations of PARC
Measured: Baseline to Week 60
Change in serum concentrations of IgE
Change in serum concentrations of IgE
Measured: Baseline to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start16 Jul 2025
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic Obstructive (COPD)Studies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039669
- Sponsor's protocol ID
- SSGJ-611-COPD-III-01
- Status last verified
- Oct 2025
- First submitted
- 5 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07039669
- Acronym / sponsor ID
- SSGJ-611-COPD-III-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
Detailed description
The maximum study duration was 66 weeks per participants, including a screening period of up to 6 weeks, a 52-week randomized treatment period, and a 8-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 611 | Experimental | Drug: 611611 Q2W, subcutaneous (SC) injection |
| placebo | Placebo comparator | Drug: Placeboplacebo Q2W, subcutaneous (SC) injection |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 611611 subcutaneous (SC) injection | Drug | 611 |
| Placeboplacebo Q2W, subcutaneous (SC) injection | Drug | placebo |
Primary outcome
Annualized rate of moderate or severe COPD Exacerbations
Time frame: Baseline to Week 52
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.
12 secondary outcomes
Change from baseline in pre-bronchodilator FEV1 at Week 24
Time frame: Baseline, Week 24
Time to first Moderate or severe COPD exacerbation
Time frame: Baseline to Week 52
Annualized rate of severe COPD Exacerbations
Time frame: Baseline to Week 52
Change from baseline in pre-bronchodilator FEV1
Time frame: Baseline to Week 52
Change from baseline in SGRQ scores
Time frame: Baseline to Week 52
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline
Time frame: Baseline to Week 16
Change from baseline in post-bronchodilator FEV1
Time frame: Baseline to Week 52
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Up to 60 Weeks
611 Concentration in Serum
Time frame: Baseline to Week 60
Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies
Time frame: Baseline to Week 60
Change in serum concentrations of Pulmonary and activation-regulated chemokine (PARC)
Time frame: Baseline to Week 60
Change in serum concentrations of IgE
Time frame: Baseline to Week 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 611 in people with Pulmonary Disease, Chronic Obstructive (COPD), run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Zhou, Master (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of moderate or severe COPD Exacerbations (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.