A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Launched by SHANGHAI CHIA TAI TIANQING PHARMACEUTICAL TECHNOLOGY DEVELOPMENT CO., LTD. · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TQC2731 injection for patients who have moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The goal is to see how effective and safe this injection is for helping people manage their symptoms better. If you are between 40 and 80 years old, have been diagnosed with COPD for at least a year, and currently use a specific combination of medications for your condition, you might be eligible to participate in this study.

Participants in this trial can expect to have regular check-ups and assessments to monitor their health while receiving the treatment. It's important to note that some people may not qualify, including those with certain other lung diseases, recent severe COPD flare-ups, or specific medical conditions. The trial is currently looking for volunteers, so if you or a family member are interested, it could be a chance to contribute to important research that may help improve treatment for COPD in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able and willing to provide written informed consent and comply with the study protocol;
• • Participant must be ≥40 to ≤80 years of age at the time of signing informed consent.
• • Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease(COPD) and a history of COPD ≥12 months with medical records or related records at the time of screening;
• • Post-bronchodilator FEV1/Forced vital capacity (FVC)\<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \< 80% during screening.
• • Modified Medical Research Council (mMRC) Dyspnea Scale grade≥2 during screening.
• • Background triple therapy (ICS+long-acting beta-agonists (LABA)+LAMA) for at least 3 months with a stable dose for at least 1 month prior to randomization; Double therapy allowed if ICS is contraindicated.
• • With a history of acute exacerbation of ≥2 moderate or ≥1 severe within the previous 12 months prior to screening.
• Exclusion Criteria:
• • COPD with asthma;
• • Subjects with active pulmonary diseases other than COPD assessed by the investigator.
• • Moderate to severe Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) occurred within 4 weeks prior to screening or during screening;
• • History of lung transplantation;
• • Previous use of TQC2731.
• • Diagnosis of alpha-1 anti-trypsin deficiency;
• • History of lung volume reduction surgery or pneumonectomy within 6 months prior to randomization, or planned lung volume reduction surgery during the study period;
• • Positive hepatitis B surface antigen, or hepatitis C virus antibody, or syphilis antibody.
• • Diagnosis of immunodeficiency, including but not limited to HIV infection;
• • Infection requiring systemic therapy within 2 weeks prior to randomization.
• • Starting rehabilitation within 4 weeks prior to randomization, or planned rehabilitation during the study period;
• • Treatment with oxygen of more than 12 hours per day.
• • Heart failure New York Heart Association (NYHA) class III or IV during the screening period.
• • History of malignancy within 5 years prior to screening, excluding cervical carcinoma in situ, ductal carcinoma in situ, etc.
• • Pregnancy or breastfeeding.