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

Status: Recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
Baotou Central Hospital
NOT_YET_RECRUITING
Baotou
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
NOT_YET_RECRUITING
Baotou
The People's Hospital of Bozhou
NOT_YET_RECRUITING
Bozhou
Cangzhou Hospital of Integrated TCM-WM·Hebei
NOT_YET_RECRUITING
Cangzhou
Jilin University Second Hospital
NOT_YET_RECRUITING
Changchun
The First Hospital of Jlin University
NOT_YET_RECRUITING
Changchun
Changsha Central Hospital
NOT_YET_RECRUITING
Changsha
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
NOT_YET_RECRUITING
Changsha
Chifeng Municipal Hospital
NOT_YET_RECRUITING
Chifeng
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Dalian Municipal Central Hospital
NOT_YET_RECRUITING
Dalian
Da Qing Long Nan Hospital
NOT_YET_RECRUITING
Daqing
Gansu Provincial Hospital
NOT_YET_RECRUITING
Gansu
Guangdong Provincial Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Guangzhou
Guangzhou First People's Hospital
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Medical University
NOT_YET_RECRUITING
Guilin
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
The Fourth Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
Anhui Chest Hoispital
NOT_YET_RECRUITING
Hefei
Heze Municipal Hospital
NOT_YET_RECRUITING
Heze
Inner Mongolia Autonomous Region People's Hospital
NOT_YET_RECRUITING
Hohhot
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Third People's Hospital of Huizhou
NOT_YET_RECRUITING
Huizhou
The Second People's Hospital of Jiaozuo City
NOT_YET_RECRUITING
Jiaozuo
Jinhua Municipal Central Hospital
NOT_YET_RECRUITING
Jinhua
Affiliated Hospital of Jining Medical Hospital
NOT_YET_RECRUITING
Jining
The First People's Hospital of Yunnan Province
NOT_YET_RECRUITING
Kunming
Lanzhou University Second Hospital
NOT_YET_RECRUITING
Lanzhou
The First Hospital of Lanzhou University
NOT_YET_RECRUITING
Lanzhou
The Second People Hospital's of Lianyungang
NOT_YET_RECRUITING
Lianyungang
Loudi central hospital
NOT_YET_RECRUITING
Loudi
Luo Yang Dong Fang People's Hospital
NOT_YET_RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Jiangsu Provincial People's Hospital
NOT_YET_RECRUITING
Nanjing
The First Affiliated Hospital of Ningbo University
NOT_YET_RECRUITING
Ningbo
Genertec Liaoyou Gem Flower Hospital
NOT_YET_RECRUITING
Panjin
Pingxiang People's Hospital
NOT_YET_RECRUITING
Pingxiang
Qiqihar First People's Hospital
NOT_YET_RECRUITING
Qiqihar
Fudan University Affiliated Zhongshan Hospital
NOT_YET_RECRUITING
Shanghai
Rui Jin Hospital Shanghai Jiaotong University School of Medical
NOT_YET_RECRUITING
Shanghai
Shanghai General Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
NOT_YET_RECRUITING
Shanghai
Shanghai Tongren Hospital
NOT_YET_RECRUITING
Shanghai
Wusong Central Hospital, Baoshan District, Shanghai
RECRUITING
Shanghai
People's Liberation Army North Theater General Hospital
NOT_YET_RECRUITING
Shenyang
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The First Affiliated Hospital of Shihezi University
NOT_YET_RECRUITING
Shihezi
Suining Central Hospital
NOT_YET_RECRUITING
Suining
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
Taizhou Central Hospital(Taizhou University Hospital)
NOT_YET_RECRUITING
Taizhou
Tianjin 4th Center Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Xinjiang Uiger Municipal People'S Hospital
NOT_YET_RECRUITING
Ürümqi
Weifang NO.2 People's Hospital
NOT_YET_RECRUITING
Weifang
Wenzhou Medical University Affiliated Second Hospital
NOT_YET_RECRUITING
Wenzhou
The Central Hospital of Wuhan
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Medical Universi
NOT_YET_RECRUITING
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Xi'an International Medical Center Hospital
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Xingtai People's Hospital
NOT_YET_RECRUITING
Xingtai
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Xuzhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
Yangquan Coal Industry Group General Hospital
NOT_YET_RECRUITING
Yangquan
Northern Jiangsu People's Hospital
NOT_YET_RECRUITING
Yangzhou
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING
Yantai
The First People's Hospital of Yinchuan
NOT_YET_RECRUITING
Yinchuan
The People's Hospital of Yuyao
NOT_YET_RECRUITING
Yuyao
Zaozhuang Municipal Hospital
NOT_YET_RECRUITING
Zaozhuang
Jiangsu University Affiliated Hospital
NOT_YET_RECRUITING
Zhenjiang
Zhongshan City People's Hospital
NOT_YET_RECRUITING
Zhongshan
Zhoukou Central hospital
NOT_YET_RECRUITING
Zhoukou
Contact Information
Primary
Jinping Zheng, Doctor
jpzhenggy@163.com
18928868238
Backup
Qingling Zhang, Doctor
zqling68@hotmail.com
13609068871
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2027-06
Participants
Target number of participants: 660
Treatments
Experimental: TQC2731 injection
TQC2731 injection, 4 weeks as a treatment cycle. Study drug administration from Day 0 up to Week 48.
Placebo_comparator: Placebo
Placebo,4 weeks as a treatment cycle.Study drug administration from Day 0 up to Week 48.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

This content was sourced from clinicaltrials.gov

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