Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.
Interventions
TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP)
DRUGTQC2731 Placebo
TQC2731 Placebo without drug substance.
Sponsors
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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. Multiple acute exacerbation events with an interval of less than 14 days are counted as one.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual rate of acute COPD exacerbation | Baseline to week 24 | Annualized rate of moderate or severe COPD exacerbations over the 24-week treatment period compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annual rate of acute COPD exacerbation | Baseline to week 52 | Annualized rate of moderate COPD exacerbations over the 52-week treatment period compared to placebo. |
| Improvement in St. George's Respiratory Questionnaire (SGRQ) | Baseline to week 52 | Proportion of patients with SGRQ improvement ≥4 points at Week 52 |
| Change in SGRQ | Baseline to week 52 | Change from baseline to Week 52 in SGRQ total score compared to placebo |
| Change in pre-bronchodilator FEV1 | Baseline to week 52 | Change in pre-bronchodilator FEV1 from baseline to week 52 compared to placebo. |
| Change in post-bronchodilator FEV1 | Baseline to week 24 and 52 | Change in post-bronchodilator FEV1 from baseline to week 24 and 52 compared to placebo. |
| Change in pre-bronchodilator forced expiratory volume (FEV1) | Baseline to week 24 | Change in pre-bronchodilator FEV1 from baseline to week 24 compared to placebo. |
| Adverse Events (AE) and Serious Adverse Events (SAE) | Baseline to 64 weeks | The incidence and severity of AE and SAE, as well as abnormal laboratory examination index. |
| Anti-drug antibodies (ADA) | Baseline through week 52 | Incidence of ADA. |
| Immunoglobulin E (IgE) | Baseline to 52 weeks | Changes in IgE levels in peripheral blood. |
| Fractional exhaled nitric oxide (FeNO) | Baseline to 52 weeks | Changes in FeNO. |
| Change in EXACT | Baseline to week 52 | Change from baseline to Week 52 in EXACT total score compared to placebo. |
Countries
China
Outcome results
None listed