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RECRUITING

NCT06829784

PHASE3

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injections in Patients With Poorly Controlled Severe Asthma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

660

Start Date

2025-03-21

Completion Date

2027-06

Last Updated

2025-04-01

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

TQC2731 injection

TQC2731 injection can specifically bind to the Thymic Stromal Lymphopoietin (TSLP) protein, blocking TSLP-dependent downstream signaling expression in engineered cells and inhibiting the production of inflammatory cytokines.

DRUG

Placebo

Placebo without drug substance.

Inclusion Criteria: * Sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial; * Age 18 \~ 75 years old, gender is not limited; * Documented physician diagnosis of asthma at least 12 months prior to Visit 1; * Subjects who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to Visit 1; * There must be a record of receiving a stable total daily dose of ICS at least 3 months prior to visit 1; * There must be a record of the use of other asthma control medications at a stable dose at least 3 months prior to visit 1; For subjects taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg every other day (or equivalent) and must be stable for at least 30 days prior to visit 1 and during treatment. * Documented at least 2 asthma exacerbations in the 12 months prior to Visit 1 and no major asthma exacerbation events in the 1 month prior to signing informed. Exclusion Criteria: * Have a clinically significant lung disease other than asthma； * Pre-existing autoimmune disease; * A history of known or suspected immunosuppression, including a history of invasive opportunistic infections; * Any disease that has not been determined to be stable by the investigator； * Cancer history: Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ are eligible to be enrolled in this study if they had completed curative therapy for at least 12 months prior to visit 1. Patients with other malignancies who had completed curative treatment for at least 5 years prior to visit 1 could be enrolled in the study. * Current smoker or smoking history ≥10 pack-years (former smokers with smoking history \<10 pack-years had quit smoking less than 6 months before interview 1); * Other factors determined by the investigator that subjects were not suitable to participate in the study.

Locations (74)

The People's Hospital of Bozhou

Bozhou, Anhui, China

Anhui Chest Hoispital

Hefei, Anhui, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Third People's Hospital of Huizhou

Huizhou, Guangdong, China

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

The Affiliated Hospital of Medical University

Guilin, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Cangzhou Hospital of Integrated TCM-WM·Hebei

Cangzhou, Hebei, China

Xingtai People's Hospital

Xingtai, Hebei, China

Da Qing Long Nan Hospital

Daqing, Heilongjiang, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Qiqihar First People's Hospital

Qiqihar, Heilongjiang, China

The Second People's Hospital of Jiaozuo City

Jiaozuo, Henan, China

Luo Yang Dong Fang People's Hospital

Luoyang, Henan, China

Zhoukou Central hospital

Zhoukou, Henan, China

The Central Hospital of Wuhan

Wuhan, Hubei, China

Changsha Central Hospital

Changsha, Hunan, China

Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

Changsha, Hunan, China

Loudi central hospital

Loudi, Hunan, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, China

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

The Second People Hospital's of Lianyungang

Lianyungang, Jiangsu, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Jiangsu University Affiliated Hospital

Zhenjiang, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

Jilin University Second Hospital

Changchun, Jilin, China

The First Hospital of Jlin University

Changchun, Jilin, China

Gansu Provincial Hospital

Gansu, Lanzhou, China

Dalian Municipal Central Hospital

Dalian, Liaoning, China

Genertec Liaoyou Gem Flower Hospital

Panjin, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

People's Liberation Army North Theater General Hospital

Shenyang, Liaoning, China

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The First Affiliated Hospital of Xi'an Medical Universi

Xi'an, Shaanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, China

Heze Municipal Hospital

Heze, Shandong, China

Affiliated Hospital of Jining Medical Hospital

Jining, Shandong, China

Weifang NO.2 People's Hospital

Weifang, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

Rui Jin Hospital Shanghai Jiaotong University School of Medical