Clinical trial NCT06707883: A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 258
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.


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.

Primary outcomes:
measure: Annual rate of acute COPD exacerbation
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Change in pre-bronchodilator forced expiratory volume (FEV1)
timeFrame: Baseline to week 24
measure: Annual rate of acute COPD exacerbation
timeFrame: Baseline to week 52
measure: Improvement in St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline to week 52
measure: Change in SGRQ
timeFrame: Baseline to week 52
measure: Change in pre-bronchodilator FEV1
timeFrame: Baseline to week 52
measure: Annual rate of acute COPD exacerbation
timeFrame: Baseline to week 52
measure: Change in post-bronchodilator FEV1
timeFrame: Baseline to week 24 and 52
measure: Change in EXACT
timeFrame: Baseline to week 52
measure: Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Baseline to 64 weeks
measure: Anti-drug antibodies (ADA)
timeFrame: Baseline through week 52
measure: Immunoglobulin E (IgE)
timeFrame: Baseline to 52 weeks
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: Baseline to 52 weeks
Other outcomes:
Locations:
city: Chuzhou
country: China
facility: The First People's Hospital of Chuzhou
state: Anhui
city: Hefei
country: China
facility: The second hospital of ANHUI medical university
state: Anhui
city: Huainan
country: China
facility: Huainan Dongfang Hospital Group General Hospital
state: Anhui
city: Beijing
country: China
facility: Capital Medical University Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Foshan
country: China
facility: Shunde Hospital Of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
city: Guilin
country: China
facility: Nanxishan Hospital of Guangxi Zhuang Autonomous
state: Guangxi
city: Yulin
country: China
facility: The First People' Hospital Of YuLin
state: Guangxi
city: Zunyi
country: China
facility: Zunyi Medical University Affiliated Hospital
state: Guizhou
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Jiaozuo
country: China
facility: Jiaozuo Second People's Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
state: Henan
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Chest Hospital
state: Henan
city: Wuhan
country: China
facility: Jianghan University Affiliated Hospital (Wuhan Sixth Hospital)
state: Hubei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: Changsha First Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan County People's Hospital
state: Hunan
city: Zhuzhou
country: China
facility: Xiangya Hospital Zhuzhou Central South University
state: Hunan
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region People's Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Jiangyin
country: China
facility: Jiangyin Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Wuxi
country: China
facility: The Fifth People's Hospital of Wuxi
state: Jiangsu
city: Wuxi
country: China
facility: Yixing People'S Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: XuZhou Central Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Xinyu
country: China
facility: Xinyu People'S Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Anshan
country: China
facility: General Hospital of Anshan Iron and Steel Group Corporation
state: Liaoning
city: Benxi
country: China
facility: Benxi Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang NO.2 People' Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai JiaoTong University of medicine Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: Affiliated Hospital Of ChengDu University
state: Sichuan
city: Guangyuan
country: China
facility: Guangyuan Central Hospital
state: Sichuan
city: Leshan
country: China
facility: Leshan People's Hospital
state: Sichuan
city: MeiShan
country: China
facility: Meishan People's Hospital
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: The Fourth Central Hospital of Tianjin
state: Tianjin
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University
state: Xinjiang
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Jiaxing
country: China
facility: Jiaxing Second Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital Central Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU
state: Zhejiang
Study officials:
References: