TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Last updated: March 30, 2025
Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

TQC2731 injection

Placebo

Clinical Study ID

NCT06829784
TQC2731-III-01
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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 controlmedications 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 3months prior to visit 1;

  • There must be a record of the use of other asthma control medications at a stabledose at least 3 months prior to visit 1; For subjects taking maintenance oralhormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg everyother day (or equivalent) and must be stable for at least 30 days prior to visit 1and during treatment.

  • Documented at least 2 asthma exacerbations in the 12 months prior to Visit 1 and nomajor asthma exacerbation events in the 1 month prior to signing informed.

Exclusion

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 invasiveopportunistic infections;

  • Any disease that has not been determined to be stable by the investigator;

  • Cancer history: Patients with basal cell carcinoma, skin localized squamous cellcarcinoma, or cervical carcinoma in situ are eligible to be enrolled in this studyif 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 5years prior to visit 1 could be enrolled in the study.

  • Current smoker or smoking history ≥10 pack-years (former smokers with smokinghistory <10 pack-years had quit smoking less than 6 months before interview 1);

  • Other factors determined by the investigator that subjects were not suitable toparticipate in the study.

Study Design

Total Participants: 660
Treatment Group(s): 2
Primary Treatment: TQC2731 injection
Phase: 3
Study Start date:
March 21, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • The People's Hospital of Bozhou

    Bozhou, Anhui 236000
    China

    Site Not Available

  • Anhui Chest Hoispital

    Hefei, Anhui 230022
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400010
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361000
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Third People's Hospital of Huizhou

    Huizhou, Guangdong 516002
    China

    Site Not Available

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong 528403
    China

    Site Not Available

  • The Affiliated Hospital of Medical University

    Guilin, Guangxi 541000
    China

    Site Not Available

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou 550000
    China

    Site Not Available

  • Cangzhou Hospital of Integrated TCM-WM·Hebei

    Cangzhou, Hebei 061000
    China

    Site Not Available

  • Xingtai People's Hospital

    Xingtai, Hebei 054001
    China

    Site Not Available

  • Da Qing Long Nan Hospital

    Daqing, Heilongjiang 163453
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Harbin Medical University

    Ha'erbin, Heilongjiang 150001
    China

    Site Not Available

  • Qiqihar First People's Hospital

    Qiqihar, Heilongjiang 161000
    China

    Site Not Available

  • The Second People's Hospital of Jiaozuo City

    Jiaozuo, Henan 454001
    China

    Site Not Available

  • Luo Yang Dong Fang People's Hospital

    Luoyang, Henan 471003
    China

    Site Not Available

  • Sanmenxia Hospital of the Yellow River

    Sanmenxia, Henan 472000
    China

    Site Not Available

  • Zhoukou Central hospital

    Zhoukou, Henan 466000
    China

    Site Not Available

  • The Central Hospital of Wuhan

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Changsha Central Hospital

    Changsha, Hunan 410000
    China

    Site Not Available

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

    Changsha, Hunan 410021
    China

    Site Not Available

  • Loudi central hospital

    Loudi, Hunan 417000
    China

    Site Not Available

  • Baotou Central Hospital

    Baotou, Inner Mongolia 014040
    China

    Site Not Available

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

    Baotou, Inner Mongolia 14000
    China

    Site Not Available

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia 024099
    China

    Site Not Available

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia 100017
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 100000
    China

    Site Not Available

  • The Second People Hospital's of Lianyungang

    Lianyungang, Jiangsu 222006
    China

    Site Not Available

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225001
    China

    Site Not Available

  • Jiangsu University Affiliated Hospital

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330038
    China

    Site Not Available

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi 337055
    China

    Site Not Available

  • Jilin University Second Hospital

    Changchun, Jilin 130000
    China

    Site Not Available

  • The First Hospital of Jlin University

    Changchun, Jilin 130000
    China

    Site Not Available

  • Gansu Provincial Hospital

    Gansu, Lanzhou 730000
    China

    Site Not Available

  • Dalian Municipal Central Hospital

    Dalian, Liaoning 116021
    China

    Site Not Available

  • Genertec Liaoyou Gem Flower Hospital

    Panjin, Liaoning 124000
    China

    Site Not Available

  • People's Liberation Army North Theater General Hospital

    Shenyang, Liaoning 130012
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia 750001
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710000
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Medical Universi

    Xi'an, Shaanxi 710000
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710000
    China

    Site Not Available

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi 710000
    China

    Site Not Available

  • Heze Municipal Hospital

    Heze, Shandong 274031
    China

    Site Not Available

  • Affiliated Hospital of Jining Medical Hospital

    Jining, Shandong 272000
    China

    Site Not Available

  • Weifang NO.2 People's Hospital

    Weifang, Shandong 261041
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264099
    China

    Site Not Available

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong 277000
    China

    Site Not Available

  • Fudan University Affiliated Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Rui Jin Hospital Shanghai Jiaotong University School of Medical

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai, Shanghai 200080
    China

    Site Not Available

  • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center

    Shanghai, Shanghai 200120
    China

    Site Not Available

  • Shanghai Tongren Hospital

    Shanghai, Shanghai 200336
    China

    Site Not Available

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Wusong Central Hospital, Baoshan District, Shanghai

    Shanghai, Shanghai 200940
    China

    Active - Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • Yangquan Coal Industry Group General Hospital

    Yangquan, Shanxi 45000
    China

    Site Not Available

  • Yangquan Coal Industry Group General Hospital

    Yangquan, Shanxi 45000
    China

    Site Not Available

  • Suining Central Hospital

    Suining, Sichuan 629000
    China

    Site Not Available

  • Zigong First People's Hospital

    Zigong, Sichuan 643000
    China

    Site Not Available

  • Tianjin 4th Center Hospital

    Tianjin, Tianjin 300140
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang 832008
    China

    Site Not Available

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830000
    China

    Site Not Available

  • Xinjiang Uiger Municipal People'S Hospital

    Ürümqi, Xinjiang 830000
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan 650000
    China

    Site Not Available

  • The People's Hospital of Yuyao

    Yuyao, Zhejaing 315400
    China

    Site Not Available

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang 321000
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315020
    China

    Site Not Available

  • Taizhou Central Hospital(Taizhou University Hospital)

    Taizhou, Zhejiang 318000
    China

    Site Not Available

  • Wenzhou Medical University Affiliated Second Hospital

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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