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

NCT07039669 | Recruiting Phase 3

• 1 other identifier: SSGJ-611-COPD-III-01
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 4

Brief Summary

The 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 (COPD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 52

Secondary Outcomes (12)

• Change from baseline in pre-bronchodilator FEV1 at Week 24

  Baseline, Week 24

• Time to first Moderate or severe COPD exacerbation

  Baseline to Week 52

• Annualized rate of severe COPD Exacerbations

  Baseline to Week 52

• Change from baseline in pre-bronchodilator FEV1

  Baseline to Week 52

• Change from baseline in SGRQ scores

  Baseline to Week 52

Study Arms (2)

611

EXPERIMENTAL

611 Q2W, subcutaneous (SC) injection

Drug: 611

placebo

PLACEBO COMPARATOR

placebo Q2W, subcutaneous (SC) injection

Drug: Placebo

Interventions

611 DRUG

611 subcutaneous (SC) injection

611

Placebo DRUG

placebo Q2W, subcutaneous (SC) injection

placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

NOT YET RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 212028, China

RECRUITING

ZheJiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Interventions

entacapone

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qinghong Zhou, Master

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 5, 2025
• First Posted: June 26, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)