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NCT Number: NCT07039669

Evaluation of 611 in Chinese Adults Patients 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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.
  • 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.

Treatment and study plan

611

Drug

611 subcutaneous (SC) injection

Placebo

Drug

placebo Q2W, subcutaneous (SC) injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from baseline in pre-bronchodilator FEV1 at Week 24

    Time frame: Baseline, Week 24

    FEV1 is the Forced expiratory volume in one second at study site

  2. Time to first Moderate or severe COPD exacerbation

    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.

  3. Annualized rate of severe COPD Exacerbations

    Time frame: Baseline to Week 52

    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.

  4. Change from baseline in pre-bronchodilator FEV1

    Time frame: Baseline to Week 52

    FEV1 is the Forced expiratory volume in one second at study site

  5. Change from baseline in SGRQ scores

    Time frame: Baseline to Week 52

    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.

  6. Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline

    Time frame: Baseline to Week 16

    Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline

  7. Change from baseline in post-bronchodilator FEV1

    Time frame: Baseline to Week 52

    FEV1 is the Forced expiratory volume in one second at study site

  8. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Up to 60 Weeks

    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).

  9. 611 Concentration in Serum

    Time frame: Baseline to Week 60

    The concentration of 611 in Serum

  10. Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies

    Time frame: Baseline to Week 60

    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%

  11. Change in serum concentrations of Pulmonary and activation-regulated chemokine (PARC)

    Time frame: Baseline to Week 60

    Change in serum concentrations of PARC

  12. Change in serum concentrations of IgE

    Time frame: Baseline to Week 60

    Change in serum concentrations of IgE

Study contacts

Contact information is provided by the study sponsor or research team.

Qinghong Zhou, Master

CONTACT

[email protected]

+86 18911301578

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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