RecruitingPhase 3NCT06829784

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

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

Sponsor

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

Enrollment

660 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

Asthma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing TQC2731 — an injectable biologic medication — for treating severe asthma that is not well controlled despite using high-dose inhaled corticosteroids and other standard asthma medications. **You may be eligible if...** - You are between 18 and 75 years old - You have had a confirmed asthma diagnosis for at least 12 months - You have been on a stable, high-dose inhaled corticosteroid (ICS) regimen for at least 6 months before the study - You have also been using another asthma controller medication alongside your ICS - Your asthma is not well controlled despite these treatments **You may NOT be eligible if...** - You have another significant lung disease (like COPD or pulmonary fibrosis) - You have active serious infections, including parasitic infections - You are currently using another injectable biologic for asthma (e.g., dupilumab, omalizumab) - You are pregnant or breastfeeding - You have recently had a severe asthma attack requiring hospitalization Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQC2731 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.

DRUGPlacebo

Placebo without drug substance.

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