Pulmonary Disease, Chronic ObstructivePhase 2NCT06099652
Evaluation of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study testing 611 300 mg Q2W and 611 450 mg Q2W in people with Pulmonary Disease, Chronic Obstructive, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 sites in China.
Trial summary
The primary 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
- What is being tested?
- 611 300 mg Q2W and 611 450 mg Q2W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 3 sitesChina
- Study dates
- 8 Dec 2023to 18 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
- Male or female adults ages 40 to 85 years old when signing the informed consent.
- BMI≥16 kg/m2.
- Documented diagnosis of COPD for at least one year prior to enrolment.
- Post-bronchodilator FEV1/FVC < 0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%.
- Current or former smokers with a smoking history of ≥10 pack-years or environmental exposure to biofuel fumes ≥10 years
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- 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.
- Patients with blood eosinophils ≥200 cells/microliter at screening.
- 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
- Significant pulmonary disease other than COPD (e.g., active tuberculosis，lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc)
- Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
- 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.
- Cor pulmonale, evidence of right cardiac failure
- Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
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- A participant with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.
- Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- Hypercapnia requiring Bi-level ventilation.
- AECOPD as defined in inclusion criteria within 4 weeks prior to screening or randomization.
- History of, or planned pneumonectomy or lung volume reduction surgery.
- Treatment with oxygen of more than 12 hours per day.
- Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
- Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
About this study
Official title: A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase II Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease.
The primary 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 28 weeks per participants, including a screening period of up to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- 611 300 mg Q2W, 611 450 mg Q2W, Matching placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
611 300 mg Q2WDrug
611 subcutaneous (SC) injection
611 450 mg Q2WDrug
611 subcutaneous (SC) injection
Matching placeboDrug
placebo subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | 611 300 mg Q2W, subcutaneous (SC) injection Receives: Drug: 611 300 mg Q2W |
| group B | Experimental | 611 450 mg Q2W, subcutaneous (SC) injection Receives: Drug: 611 450 mg Q2W |
| placebo group | Placebo comparator | placebo Q2W, subcutaneous (SC) injection Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pre-bronchodilator FEV1 at Week 16
FEV1 is the Forced expiratory volume in one second at study site
Measured: up to Week 16
Secondary outcomes (9)
Change from baseline in Chronic Obstructive Pulmonary Disease assessment tool (CAT) score
Chronic Obstructive Pulmonary Disease assessment tool (CAT) score ranges from 0 to 40, a higher score indicating a higher impact on health status.
Measured: up to Week 16
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
St. George's Respiratory Questionnaire (SGRQ) is a questionnaire designed to measure and quantify health-related health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100. Lower score indicates better quality of life.
Measured: up to Week 16
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16
St. George's Respiratory Questionnaire (SGRQ) is a questionnaire designed to measure and quantify health-related health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100. Lower score indicates better quality of life.
Measured: up to Week 16
Annualized rate of moderate to severe COPD exacerbations in participants
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD.
Moderate：Use of systemic corticosteroids; and/or use of antibiotics; Severe：An inpatient hospitalization due to COPD
Measured: up to Week 16
Time to first Moderate or severe COPD exacerbation
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD.
Moderate：Use of systemic corticosteroids; and/or use of antibiotics; Severe：An inpatient hospitalization due to COPD
Measured: up to Week 16
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.
Measured: Up to 24 Weeks
611 Concentration in Serum
The concentration of 611 in Serum
Measured: Up to 24 Weeks
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: Up to 24 Weeks
Change in serum concentrations of PD variables
PD variables included Pulmonary and activation-regulated chemokine (PARC)，IgE，blood eosinophil counts and fibrinogen
Measured: Up to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start8 Dec 2023
- Primary completion15 Apr 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099652
- Sponsor's protocol ID
- SSGJ-611-COPD-II-01
- Status last verified
- Oct 2025
- First submitted
- 19 Oct 2023
- Last updated
- 20 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 20 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 II Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT06099652
- Acronym / sponsor ID
- SSGJ-611-COPD-II-01
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 25 Oct 2023 (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 primary 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 28 weeks per participants, including a screening period of up to 4 weeks, a 16-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
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: 611 300 mg Q2W611 300 mg Q2W, subcutaneous (SC) injection |
| group B | Experimental | Drug: 611 450 mg Q2W611 450 mg Q2W, subcutaneous (SC) injection |
| placebo group | Placebo comparator | Drug: Matching 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 (10 listed)
- Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
- Male or female adults ages 40 to 85 years old when signing the informed consent.
- BMI≥16 kg/m2.
- Documented diagnosis of COPD for at least one year prior to enrolment.
- Post-bronchodilator FEV1/FVC < 0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%.
Key exclusion criteria (14 listed)
- Significant pulmonary disease other than COPD (e.g., active tuberculosis，lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc)
- Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
- 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.
- Cor pulmonale, evidence of right cardiac failure
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 |
|---|---|---|
| 611 300 mg Q2W611 subcutaneous (SC) injection | Drug | group A |
| 611 450 mg Q2W611 subcutaneous (SC) injection | Drug | group B |
| Matching placeboplacebo subcutaneous (SC) injection | Drug | placebo group |
Primary outcome
Change from baseline in pre-bronchodilator FEV1 at Week 16
Time frame: up to Week 16
FEV1 is the Forced expiratory volume in one second at study site
9 secondary outcomes
Change from baseline in Chronic Obstructive Pulmonary Disease assessment tool (CAT) score
Time frame: up to Week 16
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: up to Week 16
Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16
Time frame: up to Week 16
Annualized rate of moderate to severe COPD exacerbations in participants
Time frame: up to Week 16
Time to first Moderate or severe COPD exacerbation
Time frame: up to Week 16
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
Time frame: Up to 24 Weeks
611 Concentration in Serum
Time frame: Up to 24 Weeks
Percentage of Participants with Anti-drug Antibodies and Neutralizing Antibodies
Time frame: Up to 24 Weeks
Change in serum concentrations of PD variables
Time frame: Up to 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 611 300 mg Q2W and 611 450 mg Q2W in people with Pulmonary Disease, Chronic Obstructive, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 3 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 20 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 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pre-bronchodilator FEV1 at Week 16 (time frame: up to Week 16). 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 20 Nov 2025.