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

NCT ID: NCT06099652

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2025-06-18

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

group A

611 300 mg Q2W, subcutaneous (SC) injection

Group Type: EXPERIMENTAL

611 300 mg Q2W

Intervention Type: DRUG

611 subcutaneous (SC) injection

group B

611 450 mg Q2W, subcutaneous (SC) injection

Group Type: EXPERIMENTAL

611 450 mg Q2W

Intervention Type: DRUG

611 subcutaneous (SC) injection

placebo group

placebo Q2W, subcutaneous (SC) injection

Group Type: PLACEBO_COMPARATOR

Matching placebo

Intervention Type: DRUG

placebo subcutaneous (SC) injection

Interventions

611 300 mg Q2W

611 subcutaneous (SC) injection

Intervention Type: DRUG

611 450 mg Q2W

611 subcutaneous (SC) injection

Intervention Type: DRUG

Matching placebo

placebo subcutaneous (SC) injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.

2. Male or female adults ages 40 to 85 years old when signing the informed consent.

3. BMI≥16 kg/m2.

4. Documented diagnosis of COPD for at least one year prior to enrolment.

5. Post-bronchodilator FEV1/FVC < 0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%.

6. Current or former smokers with a smoking history of ≥10 pack-years or environmental exposure to biofuel fumes ≥10 years

7. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.

8. 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.

9. Patients with blood eosinophils ≥200 cells/microliter at screening.

10. 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.

11. History of, or planned pneumonectomy or lung volume reduction surgery.

12. Treatment with oxygen of more than 12 hours per day.

13. Known with allergic or intolerant to mometasone furoate spray or 611/placebo.

14. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

Exclusion Criteria

1. Significant pulmonary disease other than COPD (e.g., active tuberculosis，lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc)

2. Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

3. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.

4. Diagnosis of α-1 anti-trypsin deficiency.

5. Cor pulmonale, evidence of right cardiac failure

6. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).

7. 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.

8. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.

9. Hypercapnia requiring Bi-level ventilation.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SSGJ-611-COPD-II-01

Identifier Type: -

Identifier Source: org_study_id