CompletedPhase 2

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

China142 participantsStarted 2023-12-08

Plain-language summary

The primary objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.

Age range40 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Change from baseline in pre-bronchodilator FEV1 at Week 16

Timeframe: up to Week 16

NCT IDNCT06099652

SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-15

Who can participate

Age range40 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.