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

Phase 2

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: TQC2731 injection; Drug: TQC2731 Placebo

• Registration Number: NCT06707883
• Lead Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-27
• Study Start: 2024-12-31
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-12
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 258

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TQC2731 injection	TQC2731 injection	TQC2731 injection, 28days as a treatment cycle.
TQC2731 Placebo	TQC2731 Placebo	TQC2731 Placebo, 28days as a treatment cycle.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Annual rate of acute COPD exacerbation	Baseline to week 52	Annualized rate of severe 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 EXACT	Baseline to week 52	Change from baseline to Week 52 in EXACT total score 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.

Trial Locations

Locations (60)

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, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, 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

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