NCT07039669

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 594 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The 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 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.

Conditions

• Pulmonary Disease, Chronic Obstructive (COPD)

Interventions

Type	Name	Description
DRUG	611	611 subcutaneous (SC) injection
DRUG	Placebo	placebo Q2W, subcutaneous (SC) injection

Timeline

• Start date: 2025-07-16
• Primary completion: 2028-09-01
• Completion: 2028-11-01
• First posted: 2025-06-26
• Last updated: 2025-11-18

Locations

4 sites across 1 country: China