Loading clinical trials...

A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetic Characteristics of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT06789289•Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Understand and sign the written informed consent, and comply with the research process schedule during the study period.；
•Be aged 40-80 years inclusive at the time of signing the informed consent form；
•Have a record of COPD diagnosis for at least 12 months prior to screening；
•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 0.70；
•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 subject from participating in the study;
•Current or past confirmed diagnosis of asthma;
•History of other clinically significant pulmonary diseases apart from COPD: such as lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung diseases, cystic fibrosis, constrictive bronchiolitis, tuberculosis, or other active pulmonary diseases;
•Evidence of cor pulmonale with right heart failure；
•Diagnosed with α-1-antitrypsin deficiency;
•History of long-term oxygen therapy with \>4 L/min;
•When using respiratory assistive oxygen, the subject's oxygen saturation should be ≥89%;
•Undergone lung volume reduction surgery or procedures within the 12 months prior to screening;
•Subjects participating or planning to participate in an intensive COPD rehabilitation program (subjects in the maintenance phase of a rehabilitation program are eligible for this study);
•History of lung transplantation;
+19 more criteria

Locations (40)

An Hui Chest Hospital

Hefei, Anhui, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Peolpe's Hospital Of Chongqing Banan District

Chongqing, Chongqing Municipality, China

Shunde Hospital Of Southern Medical University

Foshan, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Liuzhou municipal liutie central hospital

Liuchow, Guangxi, China

The First People' Hospital Of YuLin

Yulin, Guangxi, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Xingtai People's Hospital

Xingtai, Hebei, China

Key Dates

Start Date

April 1, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

January 23, 2025

Enrollment

256

ESTIMATED participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

TQC2938 injection

DRUG

TQC2938 injection Placebo

DRUG

Contacts

Tin Yang, Doctor

CONTACT

13651380809 dryangting@qq.com

Jintong Li, Doctor

CONTACT

15300059186 gcpljt@189.cn

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

View study

RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease