AsthmaPhase 3NCT06829784
TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection
A Phase 3 study testing TQC2731 injection in people with Asthma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 101 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- TQC2731 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 101 sitesChina
- Study dates
- 21 Mar 2025to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
101 sites in 1 country. Contact the study team or a site near you to ask about taking part.
101 sites in 1 country
China101 sites, 101 recruiting
- Not yet recruiting
The People's Hospital of Anyang
Anyang, Henan, 455099
MinYong Jia, Master, 16637232623, jiaminyong@163.com
- Not yet recruiting
Baotou Central Hospital
Baotou, Inner Mongolia, 014040
Xiaoyue Chang, Master, 13847240172, btchangxiaoyue@163.com
- Not yet recruiting
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, 14000
Gaizhen Ge, Master, 15049230573, ggzhgjm@163.com
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100000
Jing Ma, Master, 13651357974, majjmail@163.com
- Not yet recruiting
Beijing No.6 Hospital
Beijing, Beijing Municipality, 100007
MinJiang Chen, Doctor, 18618340880, minjiangchen@163.com
- Not yet recruiting
The People's Hospital of Bozhou
Bozhou, Anhui, 236000
Yalin Jiang, Master, 15956792887, 94613793@qq.com
- Not yet recruiting
Cangzhou Hospital of Integrated TCM-WM·Hebei
Cangzhou, Hebei, 061000
Lei Pan, Bachelor, 18031783607, Panlei1982@126.com
- Not yet recruiting
Jilin University Second Hospital
Changchun, Jilin, 130000
Ke Wang, Doctor, 18643111766, kewangml@hotmail.com
- Not yet recruiting
The First Hospital of Jlin University
Changchun, Jilin, 130000
Liping Peng, Doctor, 13756661263, plp640317@163.com
- Not yet recruiting
Changsha Central Hospital
Changsha, Hunan, 410000
Hongzhong Yang, Doctor, 13707312398, hzhy82@sina.cn
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Yan Chen, Doctor, 13508471738, chenyan99727@163.com
- Not yet recruiting
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan, 410021
Nian Liu, Master, 13975188303, 19781138@qq.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Gang Wang, Doctor, 13228210301, wong-gang@126.com
- Not yet recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Haiying Yan, Master, 18981838295, 836566978@qq.com
- Not yet recruiting
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
Xiao Liu, Doctor, 13679093352, 514935098@qq.com
- Not yet recruiting
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024099
Xiaohua Li, Master, 18047660682, lixiaohuaaa@aliyun.com
- Not yet recruiting
Dalian Municipal Central Hospital
Dalian, Liaoning, 116021
Jian Xu, Doctor, 15509850880, karlinee@163.com
- Not yet recruiting
Da Qing Long Nan Hospital
Daqing, Heilongjiang, 163453
Jinli Liu, Bachelor, 18845980808, 969089802@qq.com
- Not yet recruiting
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Enshi, Hubei, 445000
Nianjin Gong, Doctor, 15629249688, 737694313@qq.com
- Not yet recruiting
The Eighth Afliated Hospital of Southern Medical University The First people's Hospital of Shunde
Foshan, Guangdong, 528300
Yanhua Lv, Doctor, 18923332273, lyhshunde@163.com
- Not yet recruiting
Gansu Provincial Hospital
Gansu, Lanzhou, 730000
Hong Zhang, Master, 13893654987, zhhonglz@qq.com
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Jinping Zheng, Doctor, 18928868238, jpzhenggy@163.com
- Not yet recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Lin Lin, Doctor, 13903002015, drlinlin620@163.com
- Not yet recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Hua He, Bachelor, 13711617476, hehua80@126.com
- Not yet recruiting
The Affiliated Hospital of Medical University
Guilin, Guangxi, 541000
Ming Jiang, Master, 13707830476, gljmjmjm@163.com
- Not yet recruiting
Guilin People'S Hospital
Guilin, Guangxi, 541002
Bin Huang, Bachelor, 18978320035, 38504957@qq.com
- Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000
Xianwei Ye, Doctor, 18798619198, yxw1205@163.com
- Not yet recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
Huaping Huang, Doctor, 0898-66528131, 1297034257@qq.com
- Not yet recruiting
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Shoude Jin, Doctor, 18645108766, jinshoude@163.com
- Not yet recruiting
Anhui Chest Hoispital
Hefei, Anhui, 230022
Yingchun Gao, Bachelor, 13966667699, gaoyingchun-1001@163.com
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Zhiren Yang, Master, 13965082087, 503091240@qq.com
- Not yet recruiting
Heze Municipal Hospital
Heze, Shandong, 274031
Xunchao Liu, Doctor, 13184069557, lxunchao@163.com
- Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 100000
Xiuhua Fu, Master, 13947142625, fuxiuhua555@sohu.com
- Not yet recruiting
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 100017
Huizhao Liu, Master, 18047192687, 13804713700@139.com
- Not yet recruiting
Third People's Hospital of Huizhou
Huizhou, Guangdong, 516002
Feng Wu, Bachelor, 13502436132, huizhouwufeng@126.com
- Not yet recruiting
The Second People's Hospital of Jiaozuo City
Jiaozuo, Henan, 454001
Xinju Xu, Bachelor, 13569183612, 13569183612@163.com
- Not yet recruiting
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000
Xin Wang, Doctor, 13370582931, wangxinconnie@163.com
- Not yet recruiting
Jincheng General Hospital
Jincheng, Shanxi, 48000
Xueqin Li, Master, 15934176355, lxq710103@163.com
- Not yet recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000
Dan Zhu, Bachelor, 13957962296, zhudan4252@sina.com
- Not yet recruiting
Affiliated Hospital of Jining Medical Hospital
Jining, Shandong, 272000
Bo Jiang, Master, 15666752870, 13793771252@163.com
- Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650000
Yunhui Zhang, Doctor, 13888258639, yunhuizhang3188@126.com
- Not yet recruiting
The First Affiliated of Kumming Medical University
Kunming, Yunnan, 652700
Zhuan Luo, Doctor, 18206793646, skyny4511@126.com
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoju Liu, Doctor, 13919360884, Liuxiaoju835@126.com
- Not yet recruiting
The Second Hospital & Clinical Medical School,Lanzhou University
Lanzhou, Gansu, 730000
Junnian Shi, Master, 13919778675, ldeyyzbgs@lzu.edu.cn
- Not yet recruiting
Loudi central hospital
Loudi, Hunan, 417000
Lixuan Chen, Master, 13467882042, 24870713@qq.com
- Not yet recruiting
Lu'an People's Hospital of Anhui Province
Lu'an, Anhui, 237000
Yongqing Ye, Master, 13966298133, yyq3319983@163.com
- Not yet recruiting
Luo Yang Dong Fang People's Hospital
Luoyang, Henan, 471003
Xiaolin Li, Bachelor, 13838419041, 438722670@qq.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038
Wei Zuo, Master, 15879098337, 11545394@qq.com
- Not yet recruiting
Affiliated Hospital of Jiangsu University
Nanjing, Jiangsu, 210029
Peili Sun, Master, 13851568730, Jin.sx@aliyun.com
- Not yet recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
Chao Gao, Doctor, 18258796161, caocdoctor@163.com
- Not yet recruiting
Genertec Liaoyou Gem Flower Hospital
Panjin, Liaoning, 124000
Zhaopin Yin, Bachelor, 15842797677, 154789033@qq.com
- Not yet recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Limin Dong, Bachelor, 13979972983, 1307123090@qq.com
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Fangfang Wang, Master, 18661807526, yaorao1984@163.com
- Not yet recruiting
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, 161000
Xin Zhou, Master, 13766550777, fenghuangtaiyang@163.com
- Not yet recruiting
Rui Jin Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, 200025
Ranran Dai, Doctor, 13918139360, drr11154@rjh.com.cn
- Not yet recruiting
Fudan University Affiliated Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Meiling Jin, Doctor, 13701640522, MLjin118@163.com
- Not yet recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Min Zhang, Doctor, 13482345145, maggie_zhangmin@163.com
- Not yet recruiting
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai Municipality, 200120
Ziqiang Zhang, Doctor, 18721335536, ZZQ1419@126.com
- Recruiting
Wusong Central Hospital, Baoshan District, Shanghai
Shanghai, Shanghai Municipality, 200940
Yutong Gu, Doctor, 13918919480, gu.yutong@zs-hospital.sh.cn
- Not yet recruiting
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110000
Rui Zheng, Master, 18940002266, zhengr@sj-hospital.org
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000
Rui Zheng, Master, 18940002266, zhengr@sj-hospital.org
- Not yet recruiting
People's Liberation Army North Theater General Hospital
Shenyang, Liaoning, 130012
Zhuang Ma, Doctor, 13309889964, ma-tianyi@163.com
- Not yet recruiting
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832008
Dong Liu, Master, 13779702431, 13779702431@163.com
- Not yet recruiting
Suining Central Hospital
Suining, Sichuan, 629000
Rong Qiu, Doctor, 18008258545, 443182163@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000
Ling Meng, Master, 18505386929, menglinghmy@163.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Xiaochen Li, Doctor, 13469992976, Lixiaochen3n2b@163.com
Lei Wang, Doctor, 13935107849, 13935107849@163.com
- Not yet recruiting
Taizhou Central Hospital(Taizhou University Hospital)
Taizhou, Zhejiang, 318000
Junfei Zhu, Master, 13968600802, zjf9609@126.com
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Jie Cao, Master, 13821582860, tjcaojie@sina.com
- Not yet recruiting
Tianjin 4th Center Hospital
Tianjin, Tianjin Municipality, 300140
Jingchun He, Master, 13820132084, jingjunhe98@163.com
- Not yet recruiting
Tongling People's Hospital
Tongling, Anhui, 244000
Hao Wu, Bachelor, 13866843209, Wuhao37100@163.com
- Not yet recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Zaiyi Wang, Bachelor, 13999818616, doctorwzy@126.com
- Not yet recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000
Xuemei Wei, Master, 13579846469, weixuemei@163.com
- Not yet recruiting
Weifang NO.2 People's Hospital
Weifang, Shandong, 261041
Suting Xi, Master, 18905361330, WFahxsst@163.com
- Not yet recruiting
The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325000
Liqin Wu, Master, 13587861043, happy-qin@163.com
- Not yet recruiting
The Central Hospital of Wuhan
Wuhan, Hubei, 430000
Jixiang Ni, Master, 13477838399, wcg196211@163.com
- Not yet recruiting
Wuxi Second People's Hospital
Wuxi, Jiangsu, 214002
Guijuan Xie, Master, 13915270308, summerl11.good@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Xiaomin Dang, Doctor, 18991232795, dxming112@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Medical Universi
Xi'an, Shaanxi, 710000
Shengyu Wang, Doctor, 18066721065, doc_wangsy@163.com
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Yun Liu, Doctor, 13572887605, 27556828@qq.com
- Not yet recruiting
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710000
Changgui Wu, Doctor, 13892899669, wcg196211@163.com
- Not yet recruiting
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an, Shaanxi, 710004
Jian Zhang, Master, 13991802890, 13991802890@163.com
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Yihua Lin, Doctor, 13515968915, yhlin_xm@163.com
- Not yet recruiting
No.215 Hospital of Shaanxi Nuclear Industry
Xianyang, Shanxi, 712000
Fei Yu, Bachelor, 13991026860, 13991026860@163.com
- Not yet recruiting
Xingtai People's Hospital
Xingtai, Hebei, 054001
Zhiguo Gao, Master, 13482950466, gaozhiguohao@126.com
- Not yet recruiting
Xinxiang Central Hospital
Xinxiang, Henan, 453000
Zhenbo Zhao, Master, 18336089353, feiyunlangyue@126.com
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Bi Chen, Doctor, 15005207551, chenbi207@126.com
- Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Yanmin Wu, Master, 18952170625, wymin666@126.com
- Not yet recruiting
Yangquan Coal Industry Group General Hospital
Yangquan, Shanxi, 45000
RUIBIN GUO, Bachelor, 13935324120, grb8888@126.com
- Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Ling Feng Min, Doctor, 18051061783, minlingfeng@126.com
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099
Shenchun Zou, Master, 18660515179, ytbqjwhx@sina.com
- Not yet recruiting
Yibin Second People's Hospital
Yibin, Sichuan, 644000
Hao Xiong, Bachelor, 13808299155, xionghao1124@163.com
- Not yet recruiting
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, 750001
Lijun Chen, Doctor, 13895016600, ycchenlj@163.com
- Not yet recruiting
The People's Hospital of Yuyao
Yuyao, Zhejaing, 315400
Xiaodong Wu, Master, 13305846057, WXD19680407@sina.com
- Not yet recruiting
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277000
Li Sun, Master, 13863210551, zijin_99@163.com
- Not yet recruiting
Zhangzhou Municipal Hospital of Fujian
Zhangzhou, Fujian, 363000
Lin Li, Bachelor, 13605080222, linlid222@163.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Xiaoju Zhang, Doctor, 15837101166, 15837101166@163.com
- Not yet recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan, 450007
Hua Zhang, Doctor, 13026615989, luckzhanghua@163.com
- Not yet recruiting
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, 212001
Fenhong Qian, Doctor, 13815158537, Zhaoqian604@126.com
- Not yet recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403
Jianping Liang, Bachelor, 13902825266, 13902825266@163.com
- Not yet recruiting
Zhoukou Central hospital
Zhoukou, Henan, 466000
Yong Liu, Master, 13526258730, zyliu04@sina.com
- Not yet recruiting
Zibo Central Hospital
Zibo, Shandong, 250036
Xinda Yin, Master, 18678186315, 18678186315@163.com
About this study
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
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.
- Conditions
- Asthma
- Being tested
- TQC2731 injection, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC2731 injectionDrug
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.
PlaceboDrug
Placebo without drug substance.
| Study group | Role | What they receive |
|---|---|---|
| TQC2731 injection | Experimental | TQC2731 injection, 4 weeks as a treatment cycle. Study drug administration from Day 0 up to Week 48. Receives: Drug: TQC2731 injection |
| Placebo | Placebo comparator | Placebo,4 weeks as a treatment cycle.Study drug administration from Day 0 up to Week 48. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized incidence of asthma exacerbations
Annualized incidence of asthma exacerbations (AAER) during the 52-week treatment period.
Measured: From the first day of dosing to the completion of 52 weeks of treatment
Secondary outcomes (15)
The change in forced expiratory volume in 1 second (FEV1)
At Week 52, the change from baseline in forced expiratory volume in 1 second (FEV1) prior to dosing and before the use of a bronchodilator (pre-BD administration).
Measured: Week 52 before dosing and before the use of bronchodilators (pre-Bronchodilator (pre-BD) administration)
Change in total score of standardized asthma quality of life questionnaire
Change from baseline in standardized asthma quality of life questionnaire (AQLQ(S)+12) total score at week 52. Scores above 5 points indicate a relatively good quality of life, while scores below 3 points suggest a relatively poor quality of life.
Measured: From baseline to week 52
Change in Asthma Control Questionnaire-6 (ACQ-6) score
Mean change from baseline in weekly mean asthma symptom diary score at week 52, , The higher the score, the more severe the asthma symptoms.
Measured: From baseline to week 52
Mean change in weekly mean asthma symptom diary score
Mean change from baseline in weekly mean asthma symptom diary score at week 52
Measured: From baseline to week 52
Change in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score
Change from baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score at Week 52, a higher score indicates a better quality of life.
Measured: From baseline to week 52
Change in mean rescue medication use, average peak expiratory flow rate (PEF) in the morning and night
Change from baseline in the average weekly dose of rescue medication and the average peak expiratory flow rate (PEF) per week in the morning and night, respectively
Measured: From baseline to week 52
Changes in exhaled nitric oxide Fractional exhaled nitric oxide (FENO) (ppb), peripheral blood eosinophils, total serum Immunoglobulin E (IgE).
Change from baseline in exhaled nitric oxide FENO (ppb) at week 52.
Measured: From baseline to week 52
Changes in peripheral blood eosinophils
Change from baseline in peripheral blood eosinophils at week 52.
Measured: From baseline to week 52
Changes in total serum IgE
Change from baseline in total serum IgE at week 52.
Measured: From baseline to week 52
Time to first asthma exacerbation
Time to first asthma exacerbation
Measured: Baseline to week 64
Proportion of subjects with ≥1 asthma exacerbation
Proportion of subjects with ≥1 asthma exacerbation
Measured: Baseline to week 64
Number of days of glucocorticoid use due to acute exacerbations
Number of days of glucocorticoid use due to acute exacerbations
Measured: Baseline to week 64
Average amount of hormone used per acute exacerbation (prednisone equivalent)
Average amount of hormone used per acute exacerbation (prednisone equivalent)
Measured: Baseline to week 64
Incidence of anti-drug antibodies (ADAs) in subjects
Immunogenicity: Incidence of anti-drug antibodies (ADAs) in subjects and their titers.
Measured: Baseline to week 64
Incidence of neutralizing antibodies(NAB) in subjects
Immunogenicity: Incidence of neutralizing antibodies (NAB).
Measured: Baseline to week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start21 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829784
- Sponsor's protocol ID
- TQC2731-III-01
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06829784
- Acronym / sponsor ID
- TQC2731-III-01
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQC2731 injection | Experimental | Drug: TQC2731 injectionTQC2731 injection, 4 weeks as a treatment cycle. Study drug administration from Day 0 up to Week 48. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo,4 weeks as a treatment cycle.Study drug administration from Day 0 up to Week 48. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQC2731 injectionTQC2731 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 | TQC2731 injection |
| PlaceboPlacebo without drug substance. | Drug | Placebo |
Primary outcome
Annualized incidence of asthma exacerbations
Time frame: From the first day of dosing to the completion of 52 weeks of treatment
Annualized incidence of asthma exacerbations (AAER) during the 52-week treatment period.
15 secondary outcomes
The change in forced expiratory volume in 1 second (FEV1)
Time frame: Week 52 before dosing and before the use of bronchodilators (pre-Bronchodilator (pre-BD) administration)
Change in total score of standardized asthma quality of life questionnaire
Time frame: From baseline to week 52
Change in Asthma Control Questionnaire-6 (ACQ-6) score
Time frame: From baseline to week 52
Mean change in weekly mean asthma symptom diary score
Time frame: From baseline to week 52
Change in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score
Time frame: From baseline to week 52
Change in mean rescue medication use, average peak expiratory flow rate (PEF) in the morning and night
Time frame: From baseline to week 52
Changes in exhaled nitric oxide Fractional exhaled nitric oxide (FENO) (ppb), peripheral blood eosinophils, total serum Immunoglobulin E (IgE).
Time frame: From baseline to week 52
Changes in peripheral blood eosinophils
Time frame: From baseline to week 52
Changes in total serum IgE
Time frame: From baseline to week 52
Time to first asthma exacerbation
Time frame: Baseline to week 64
Proportion of subjects with ≥1 asthma exacerbation
Time frame: Baseline to week 64
Number of days of glucocorticoid use due to acute exacerbations
Time frame: Baseline to week 64
Average amount of hormone used per acute exacerbation (prednisone equivalent)
Time frame: Baseline to week 64
Incidence of anti-drug antibodies (ADAs) in subjects
Time frame: Baseline to week 64
Incidence of neutralizing antibodies(NAB) in subjects
Time frame: Baseline to week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
101 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQC2731 injection in people with Asthma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 101 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinping Zheng, Doctor (18928868238, jpzhenggy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized incidence of asthma exacerbations (time frame: From the first day of dosing to the completion of 52 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.