To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
258
TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP)
TQC2731 Placebo without drug substance.
Annual rate of acute COPD exacerbation
Annualized rate of moderate or severe COPD exacerbations over the 24-week treatment period compared to placebo
Time frame: Baseline to week 24
Change in pre-bronchodilator forced expiratory volume (FEV1)
Change in pre-bronchodilator FEV1 from baseline to week 24 compared to placebo.
Time frame: Baseline to week 24
Annual rate of acute COPD exacerbation
Annualized rate of moderate COPD exacerbations over the 52-week treatment period compared to placebo.
Time frame: Baseline to week 52
Improvement in St. George's Respiratory Questionnaire (SGRQ)
Proportion of patients with SGRQ improvement ≥4 points at Week 52
Time frame: Baseline to week 52
Change in SGRQ
Change from baseline to Week 52 in SGRQ total score compared to placebo
Time frame: Baseline to week 52
Change in pre-bronchodilator FEV1
Change in pre-bronchodilator FEV1 from baseline to week 52 compared to placebo.
Time frame: Baseline to week 52
Annual rate of acute COPD exacerbation
Annualized rate of severe COPD exacerbations over the 52-week treatment period compared to placebo.
Time frame: Baseline to week 52
Change in post-bronchodilator FEV1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The First People's Hospital of Chuzhou
Chuzhou, Anhui, China
The second hospital of ANHUI medical university
Hefei, Anhui, China
Huainan Dongfang Hospital Group General Hospital
Huainan, Anhui, China
Capital Medical University Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Shunde Hospital Of Southern Medical University
Foshan, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, China
...and 50 more locations
Change in post-bronchodilator FEV1 from baseline to week 24 and 52 compared to placebo.
Time frame: Baseline to week 24 and 52
Change in EXACT
Change from baseline to Week 52 in EXACT total score compared to placebo.
Time frame: Baseline to week 52
Adverse Events (AE) and Serious Adverse Events (SAE)
The incidence and severity of AE and SAE, as well as abnormal laboratory examination index.
Time frame: Baseline to 64 weeks
Anti-drug antibodies (ADA)
Incidence of ADA.
Time frame: Baseline through week 52
Immunoglobulin E (IgE)
Changes in IgE levels in peripheral blood.
Time frame: Baseline to 52 weeks
Fractional exhaled nitric oxide (FeNO)
Changes in FeNO.
Time frame: Baseline to 52 weeks