Evaluating TQC2731 injection for chronic obstructive pulmonary disease

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This study is testing a new injection called TQC2731 to see if it can help people with moderate to severe COPD breathe better and feel improved.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 60 sites (Chuzhou, Anhui and 59 other locations)
• Trial ID: NCT06707883 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the efficacy and safety of TQC2731 injection in patients suffering from moderate to severe chronic obstructive pulmonary disease (COPD). Participants will receive either the TQC2731 injection or a placebo, and their responses will be monitored to determine the treatment's effectiveness. The study will include patients aged 40 to 80 who have a documented history of COPD and meet specific lung function criteria. The goal is to provide insights into a new potential therapy for managing COPD symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 with a confirmed diagnosis of moderate to severe COPD and a history of exacerbations.

Not a fit: Patients with asthma-related COPD or those with active pulmonary infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of symptoms in patients with moderate to severe COPD.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in developing new treatments for COPD.

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.

Where this trial is running

Chuzhou, Anhui and 59 other locations

• The First People's Hospital of Chuzhou — Chuzhou, Anhui, China (Not_yet_recruiting)
• The second hospital of ANHUI medical university — Hefei, Anhui, China (Not_yet_recruiting)
• Huainan Dongfang Hospital Group General Hospital — Huainan, Anhui, China (Not_yet_recruiting)
• Capital Medical University Beijing Chaoyang Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Shunde Hospital Of Southern Medical University — Foshan, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (Not_yet_recruiting)
• Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital — Qingyuan, Guangdong, China (Not_yet_recruiting)
• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (Not_yet_recruiting)
• Nanxishan Hospital of Guangxi Zhuang Autonomous — Guilin, Guangxi, China (Not_yet_recruiting)
• The First People' Hospital Of YuLin — Yulin, Guangxi, China (Not_yet_recruiting)
• Zunyi Medical University Affiliated Hospital — Zunyi, Guizhou, China (Not_yet_recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Jiaozuo Second People's Hospital — Jiaozuo, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (Not_yet_recruiting)
• Puyang Oilfield General Hospital — Puyang, Henan, China (Not_yet_recruiting)
• Henan Chest Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Jianghan University Affiliated Hospital (Wuhan Sixth Hospital) — Wuhan, Hubei, China (Not_yet_recruiting)
• Wuhan Central Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Yichang Central People's Hospital — Yichang, Hubei, China (Not_yet_recruiting)
• Changsha First Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangtan County People's Hospital — Xiangtan, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital Zhuzhou Central South University — Zhuzhou, Hunan, China (Not_yet_recruiting)
• Inner Mongolia Autonomous Region People's Hospital — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• Jiangyin Hospital of Traditional Chinese Medicine — Jiangyin, Jiangsu, China (Not_yet_recruiting)
• The Fifth People's Hospital of Wuxi — Wuxi, Jiangsu, China (Not_yet_recruiting)
• Yixing People'S Hospital — Wuxi, Jiangsu, China (Not_yet_recruiting)
• XuZhou Central Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Xinyu People'S Hospital — Xinyu, Jiangxi, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• General Hospital of Anshan Iron and Steel Group Corporation — Anshan, Liaoning, China (Not_yet_recruiting)
• Benxi Central Hospital — Benxi, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Heze Municipal Hospital — Heze, Shandong, China (Not_yet_recruiting)
• Linyi People's Hospital — Linyi, Shandong, China (Not_yet_recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
• Weifang NO.2 People' Hospital — Weifang, Shandong, China (Not_yet_recruiting)
• Shanghai General Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• Shanghai JiaoTong University of medicine Ruijin Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• Affiliated Hospital Of ChengDu University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Guangyuan Central Hospital — Guangyuan, Sichuan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jinping Zheng, Master

Conditions Chronic Obstructive Pulmonary Disease