TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Recruiting · NCT06829784 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

View the official record on ClinicalTrials.gov →

Asthma

Interventions studied

PlaceboTQC2731 injection

What this trial is about

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 trial participants are expected to be enrolled, with trial participants randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.

Who can take part

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed.

The People's Hospital of Bozhou - Bozhou, Anhui, China
Anhui Chest Hoispital - Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
Lu'an People's Hospital of Anhui Province - Lu'an, Anhui, China
Tongling People's Hospital - Tongling, Anhui, China
Peking University First Hospital - Beijing, Beijing Municipality, China
Beijing No.6 Hospital - Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University - Xiamen, Fujian, China
Zhangzhou Municipal Hospital of Fujian - Zhangzhou, Fujian, China
The First Hospital of Lanzhou University - Lanzhou, Gansu, China
The Second Hospital & Clinical Medical School,Lanzhou University - Lanzhou, Gansu, China
The Eighth Afliated Hospital of Southern Medical University The First people's Hospital of Shunde - Foshan, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University - Guangzhou, Guangdong, 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
Guilin People'S Hospital - Guilin, Guangxi, China
Guizhou Provincial People's Hospital - Guiyang, Guizhou, China
The First Affiliated Hospital of Hainan Medical University - Haikou, Hainan, 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
The First Hospital of Qiqihar - Qiqihar, Heilongjiang, China
The People's Hospital of Anyang - Anyang, Henan, China
The Second People's Hospital of Jiaozuo City - Jiaozuo, Henan, China
Luo Yang Dong Fang People's Hospital - Luoyang, Henan, China
Xinxiang Central Hospital - Xinxiang, Henan, China
Henan Provincial People's Hospital - Zhengzhou, Henan, China
Zhengzhou Central Hospital - Zhengzhou, Henan, China
Zhoukou Central hospital - Zhoukou, Henan, China
Enshi Tujia and Miao Autonomous Prefecture Central Hospital - Enshi, Hubei, China
The Central Hospital of Wuhan - Wuhan, Hubei, China
Changsha Central Hospital - Changsha, Hunan, China
The Second Xiangya Hospital of Central South University - 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
Affiliated Hospital of Jiangsu University - Nanjing, Jiangsu, China
Wuxi Second People's Hospital - Wuxi, 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 affiliated to China Medical University - Shenyang, Liaoning, China
Shengjing Hospital of China Medical University - Shenyang, Liaoning, China
People's Liberation Army North Theater General Hospital - Shenyang, Liaoning, China

Showing 60 of 101 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →