A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Seve… (NCT06789289) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
China256 participantsStarted 2025-03-17
Plain-language summary
The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TQC2938 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It is anticipated that 256 subjects will be enrolled.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion Criteria:
* Understand and sign the written informed consent, and comply with the research process schedule during the study period.ï¼›
* Be aged 40-80 years inclusive at the time of signing the informed consent formï¼›
* Have a record of COPD diagnosis for at least 12 months prior to screeningï¼›
* At screening or after bronchodilator use at the time of the first dose, FEV1 is ≥20% but \<80% of the predicted value;
* The FEV1/forced vital capacity (FVC) ratio, measured after the use of bronchodilators at screening or at the time of the first dose, is less than 0.70ï¼›
* At screening, the Modified Medical Research Council (mMRC) score is ≥2;
* At screening, the CAT≥10;
* Current smokers or former smokers (who have quit smoking for at least 6 months before Visit 1) with a smoking history of ≥10 pack-years (for example: 20 cigarettes/day for 10 years). At screening, subjects who meet the definition of current smokers will be referred to a smoking cessation clinic;
* A chest X-ray or computed tomography (CT) scan within the 3 months prior to screening or during the screening period (before the first dose of study medication) confirms that there are no other clinically significant pulmonary diseases present apart from COPD.
Exclusion Criteria:
* History of severe allergic reactions or anaphylaxis to biologic agents, or known hypersensitivity to any component of the study drug, or a history of medications or other allergens that the investigator believes would prevent the sub…
What they're measuring
1
The annualized incidence rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD within 24 weeks
Timeframe: Baseline up to week 24
Trial details
NCT IDNCT06789289
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.