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

NCT06099652 | Completed Phase 2

• 1 other identifier: SSGJ-611-COPD-II-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 3

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pre-bronchodilator FEV1 at Week 16

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

  up to Week 16

Secondary Outcomes (9)

• Change from baseline in Chronic Obstructive Pulmonary Disease assessment tool (CAT) score

  up to Week 16

• Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score

  up to Week 16

• Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16

  up to Week 16

• Annualized rate of moderate to severe COPD exacerbations in participants

  up to Week 16

• Time to first Moderate or severe COPD exacerbation

  up to Week 16

Study Arms (3)

group A

EXPERIMENTAL

611 300 mg Q2W, subcutaneous (SC) injection

Drug: 611 300 mg Q2W

group B

EXPERIMENTAL

611 450 mg Q2W, subcutaneous (SC) injection

Drug: 611 450 mg Q2W

placebo group

PLACEBO COMPARATOR

placebo Q2W, subcutaneous (SC) injection

Drug: Matching placebo

Interventions

611 300 mg Q2W DRUG

611 subcutaneous (SC) injection

group A

611 450 mg Q2W DRUG

611 subcutaneous (SC) injection

group B

Matching placebo DRUG

placebo subcutaneous (SC) injection

placebo group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (3)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

entacapone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: December 8, 2023
• Primary Completion: April 15, 2025
• Study Completion: June 18, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)