Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06829784

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2025-04-01

660

Participants Needed

74

Research Sites

114 weeks

Total Duration

On this page

AI-Summary

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 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.

CONDITIONS

Official Title

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent to understand trial purpose and risks
  • Age between 18 and 75 years, any gender
  • Physician-diagnosed asthma for at least 12 months before enrollment
  • Use of high-dose inhaled corticosteroids for at least 6 months before enrollment
  • Stable total daily dose of inhaled corticosteroids for at least 3 months prior to enrollment
  • Stable use of other asthma control medications for at least 3 months prior to enrollment
  • If on maintenance oral steroids, dose up to 10mg prednisone daily or 20mg every other day, stable for at least 30 days before enrollment and during treatment
  • At least 2 asthma exacerbations in the 12 months before enrollment
  • No major asthma exacerbations in the 1 month before consent
Not Eligible

You will not qualify if you...

  • Presence of clinically significant lung diseases other than asthma
  • Pre-existing autoimmune diseases
  • History or suspicion of immunosuppression or invasive opportunistic infections
  • Any disease not considered stable by the investigator
  • Recent cancer history except for certain skin or cervical cancers treated over 12 months ago or other cancers treated over 5 years ago
  • Current smokers or those with a smoking history of 10 or more pack-years
  • Former smokers with less than 10 pack-years who quit less than 6 months before screening
  • Other conditions deemed unsuitable for participation by the investigator

AI-Screening

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Trial Site Locations

Total: 74 locations

1

The People's Hospital of Bozhou

Bozhou, Anhui, China, 236000

Not Yet Recruiting

2

Anhui Chest Hoispital

Hefei, Anhui, China, 230022

Not Yet Recruiting

3

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400010

Not Yet Recruiting

4

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361000

Not Yet Recruiting

5

Lanzhou University Second Hospital

Lanzhou, Gansu, China, 730000

Not Yet Recruiting

6

The First Hospital of Lanzhou University

Lanzhou, Gansu, China, 730000

Not Yet Recruiting

7

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China, 510120

Not Yet Recruiting

8

Guangzhou First People's Hospital

Guangzhou, Guangdong, China, 510180

Not Yet Recruiting

9

Third People's Hospital of Huizhou

Huizhou, Guangdong, China, 516002

Not Yet Recruiting

10

Zhongshan City People's Hospital

Zhongshan, Guangdong, China, 528403

Not Yet Recruiting

11

The Affiliated Hospital of Medical University

Guilin, Guangxi, China, 541000

Not Yet Recruiting

12

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China, 550000

Not Yet Recruiting

13

Cangzhou Hospital of Integrated TCM-WM·Hebei

Cangzhou, Hebei, China, 061000

Not Yet Recruiting

14

Xingtai People's Hospital

Xingtai, Hebei, China, 054001

Not Yet Recruiting

15

Da Qing Long Nan Hospital

Daqing, Heilongjiang, China, 163453

Not Yet Recruiting

16

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150001

Not Yet Recruiting

17

Qiqihar First People's Hospital

Qiqihar, Heilongjiang, China, 161000

Not Yet Recruiting

18

The Second People's Hospital of Jiaozuo City

Jiaozuo, Henan, China, 454001

Not Yet Recruiting

19

Luo Yang Dong Fang People's Hospital

Luoyang, Henan, China, 471003

Not Yet Recruiting

20

Zhoukou Central hospital

Zhoukou, Henan, China, 466000

Not Yet Recruiting

21

The Central Hospital of Wuhan

Wuhan, Hubei, China, 430000

Not Yet Recruiting

22

Changsha Central Hospital

Changsha, Hunan, China, 410000

Not Yet Recruiting

23

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

Changsha, Hunan, China, 410021

Not Yet Recruiting

24

Loudi central hospital

Loudi, Hunan, China, 417000

Not Yet Recruiting

25

Baotou Central Hospital

Baotou, Inner Mongolia, China, 014040

Not Yet Recruiting

26

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

Baotou, Inner Mongolia, China, 14000

Not Yet Recruiting

27

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China, 024099

Not Yet Recruiting

28

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China, 100000

Not Yet Recruiting

29

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China, 100017

Not Yet Recruiting

30

The Second People Hospital's of Lianyungang

Lianyungang, Jiangsu, China, 222006

Not Yet Recruiting

31

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China, 210029

Not Yet Recruiting

32

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Not Yet Recruiting

33

Xuzhou Central Hospital

Xuzhou, Jiangsu, China, 221000

Not Yet Recruiting

34

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China, 225001

Not Yet Recruiting

35

Jiangsu University Affiliated Hospital

Zhenjiang, Jiangsu, China, 212001

Not Yet Recruiting

36

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330038

Not Yet Recruiting

37

Pingxiang People's Hospital

Pingxiang, Jiangxi, China, 337055

Not Yet Recruiting

38

Jilin University Second Hospital

Changchun, Jilin, China, 130000

Not Yet Recruiting

39

The First Hospital of Jlin University

Changchun, Jilin, China, 130000

Not Yet Recruiting

40

Gansu Provincial Hospital

Gansu, Lanzhou, China, 730000

Not Yet Recruiting

41

Dalian Municipal Central Hospital

Dalian, Liaoning, China, 116021

Not Yet Recruiting

42

Genertec Liaoyou Gem Flower Hospital

Panjin, Liaoning, China, 124000

Not Yet Recruiting

43

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110000

Not Yet Recruiting

44

People's Liberation Army North Theater General Hospital

Shenyang, Liaoning, China, 130012

Not Yet Recruiting

45

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China, 750001

Not Yet Recruiting

46

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

47

The First Affiliated Hospital of Xi'an Medical Universi

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

48

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

49

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

50

Heze Municipal Hospital

Heze, Shandong, China, 274031

Not Yet Recruiting

51

Affiliated Hospital of Jining Medical Hospital

Jining, Shandong, China, 272000

Not Yet Recruiting

52

Weifang NO.2 People's Hospital

Weifang, Shandong, China, 261041

Not Yet Recruiting

53

Yantai Yuhuangding Hospital

Yantai, Shandong, China, 264099

Not Yet Recruiting

54

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China, 277000

Not Yet Recruiting

55

Rui Jin Hospital Shanghai Jiaotong University School of Medical

Shanghai, Shanghai Municipality, China, 200025

Not Yet Recruiting

56

Fudan University Affiliated Zhongshan Hospital

Shanghai, Shanghai Municipality, China, 200032

Not Yet Recruiting

57

Shanghai General Hospital

Shanghai, Shanghai Municipality, China, 200080

Not Yet Recruiting

58

Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center

Shanghai, Shanghai Municipality, China, 200120

Not Yet Recruiting

59

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, China, 200336

Not Yet Recruiting

60

Wusong Central Hospital, Baoshan District, Shanghai

Shanghai, Shanghai Municipality, China, 200940

Actively Recruiting

61

Shanxi Bethune Hospital

Taiyuan, Shanxi, China, 030032

Not Yet Recruiting

62

Yangquan Coal Industry Group General Hospital

Yangquan, Shanxi, China, 45000

Not Yet Recruiting

63

Suining Central Hospital

Suining, Sichuan, China, 629000

Not Yet Recruiting

64

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China, 300052

Not Yet Recruiting

65

Tianjin 4th Center Hospital

Tianjin, Tianjin Municipality, China, 300140

Not Yet Recruiting

66

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang, China, 832008

Not Yet Recruiting

67

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China, 830000

Not Yet Recruiting

68

Xinjiang Uiger Municipal People'S Hospital

Ürümqi, Xinjiang, China, 830000

Not Yet Recruiting

69

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China, 650000

Not Yet Recruiting

70

The People's Hospital of Yuyao

Yuyao, Zhejaing, China, 315400

Not Yet Recruiting

71

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China, 321000

Not Yet Recruiting

72

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China, 315020

Not Yet Recruiting

73

Taizhou Central Hospital(Taizhou University Hospital)

Taizhou, Zhejiang, China, 318000

Not Yet Recruiting

74

Wenzhou Medical University Affiliated Second Hospital

Wenzhou, Zhejiang, China, 325000

Not Yet Recruiting

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Research Team

J

Jinping Zheng, Doctor

CONTACT

Q

Qingling Zhang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection | DecenTrialz