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COMPLETEDPHASE2

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

A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase II Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease.

NCT06099652•Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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.

Locations (3)

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

Key Dates

Start Date

December 8, 2023

Primary Completion Date

April 15, 2025

Completion Date

June 18, 2025

Last Updated

November 20, 2025

Enrollment

142

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

611 300 mg Q2W

DRUG

611 450 mg Q2W

DRUG

Matching placebo

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

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Asthma BronchialeBreast Neoplasms+11 more

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RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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