TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

March 30, 2025 updated by: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

660

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bozhou, Anhui, China, 236000
        • Not yet recruiting
        • The People's Hospital of Bozhou
        • Contact:
      • Hefei, Anhui, China, 230022
        • Not yet recruiting
        • Anhui Chest Hoispital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • The First Hospital of Lanzhou University
        • Contact:
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Not yet recruiting
        • Guangzhou First People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
      • Huizhou, Guangdong, China, 516002
        • Not yet recruiting
        • Third People's Hospital of Huizhou
        • Contact:
      • Zhongshan, Guangdong, China, 528403
        • Not yet recruiting
        • Zhongshan City People's Hospital
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China, 541000
        • Not yet recruiting
        • The Affiliated Hospital of Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Not yet recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
    • Hebei
      • Cangzhou, Hebei, China, 061000
        • Not yet recruiting
        • Cangzhou Hospital of Integrated TCM-WM·Hebei
        • Contact:
      • Xingtai, Hebei, China, 054001
        • Not yet recruiting
        • Xingtai People's Hospital
        • Contact:
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163453
        • Not yet recruiting
        • Da Qing Long Nan Hospital
        • Contact:
      • Ha'erbin, Heilongjiang, China, 150001
        • Not yet recruiting
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contact:
      • Qiqihar, Heilongjiang, China, 161000
        • Not yet recruiting
        • Qiqihar First People's Hospital
        • Contact:
    • Henan
      • Jiaozuo, Henan, China, 454001
        • Not yet recruiting
        • The Second People's Hospital of Jiaozuo City
        • Contact:
      • Luoyang, Henan, China, 471003
        • Not yet recruiting
        • Luo Yang Dong Fang People's Hospital
        • Contact:
      • Zhoukou, Henan, China, 466000
        • Not yet recruiting
        • Zhoukou Central Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • The Central Hospital of Wuhan
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Changsha Central Hospital
        • Contact:
          • Hongzhong Yang, Doctor
          • Phone Number: 13707312398
          • Email: hzhy82@sina.cn
      • Changsha, Hunan, China, 410021
        • Not yet recruiting
        • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
        • Contact:
      • Loudi, Hunan, China, 417000
        • Not yet recruiting
        • Loudi Central Hospital
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
        • Not yet recruiting
        • Baotou Central Hospital
        • Contact:
      • Baotou, Inner Mongolia, China, 14000
        • Not yet recruiting
        • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
        • Contact:
      • Chifeng, Inner Mongolia, China, 024099
        • Not yet recruiting
        • Chifeng Municipal Hospital
        • Contact:
      • Hohhot, Inner Mongolia, China, 100000
        • Not yet recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
      • Hohhot, Inner Mongolia, China, 100017
        • Not yet recruiting
        • Inner Mongolia Autonomous Region People's Hospital
        • Contact:
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222006
        • Not yet recruiting
        • The Second People Hospital's of Lianyungang
        • Contact:
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
      • Yangzhou, Jiangsu, China, 225001
        • Not yet recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
      • Zhenjiang, Jiangsu, China, 212001
        • Not yet recruiting
        • Jiangsu University Affiliated Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330038
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Pingxiang, Jiangxi, China, 337055
        • Not yet recruiting
        • Pingxiang People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • Jilin University Second Hospital
        • Contact:
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • The First Hospital of Jlin University
        • Contact:
    • Lanzhou
      • Gansu, Lanzhou, China, 730000
        • Not yet recruiting
        • Gansu Provincial Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116021
        • Not yet recruiting
        • Dalian Municipal Central Hospital
        • Contact:
      • Panjin, Liaoning, China, 124000
        • Not yet recruiting
        • Genertec Liaoyou Gem Flower Hospital
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 130012
        • Not yet recruiting
        • People's Liberation Army North Theater General Hospital
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750001
        • Not yet recruiting
        • The First People's Hospital of Yinchuan
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Medical Universi
        • Contact:
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • Xi'an International Medical Center Hospital
        • Contact:
    • Shandong
      • Heze, Shandong, China, 274031
        • Not yet recruiting
        • Heze Municipal Hospital
        • Contact:
      • Jining, Shandong, China, 272000
        • Not yet recruiting
        • Affiliated Hospital of Jining Medical Hospital
        • Contact:
      • Weifang, Shandong, China, 261041
        • Not yet recruiting
        • Weifang NO.2 People's Hospital
        • Contact:
      • Yantai, Shandong, China, 264099
        • Not yet recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
      • Zaozhuang, Shandong, China, 277000
        • Not yet recruiting
        • Zaozhuang Municipal Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200336
        • Not yet recruiting
        • Shanghai Tongren Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200025
        • Not yet recruiting
        • Rui Jin Hospital Shanghai Jiaotong University School of Medical
        • Contact:
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Affiliated Zhongshan Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200120
        • Not yet recruiting
        • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
        • Contact:
      • Shanghai, Shanghai, China, 200940
        • Recruiting
        • Wusong Central Hospital, Baoshan District, Shanghai
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Yangquan, Shanxi, China, 45000
        • Not yet recruiting
        • Yangquan Coal Industry Group General Hospital
        • Contact:
    • Sichuan
      • Suining, Sichuan, China, 629000
        • Not yet recruiting
        • Suining Central Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300140
        • Not yet recruiting
        • Tianjin 4th Center Hospital
        • Contact:
    • Xinjiang
      • Shihezi, Xinjiang, China, 832008
        • Not yet recruiting
        • The First Affiliated Hospital of Shihezi University
        • Contact:
      • Ürümqi, Xinjiang, China, 830000
        • Not yet recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
      • Ürümqi, Xinjiang, China, 830000
        • Not yet recruiting
        • Xinjiang Uiger Municipal People'S Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Not yet recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:
    • Zhejaing
      • Yuyao, Zhejaing, China, 315400
        • Not yet recruiting
        • The People's Hospital of Yuyao
        • Contact:
    • Zhejiang
      • Jinhua, Zhejiang, China, 321000
        • Not yet recruiting
        • Jinhua Municipal Central Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315020
        • Not yet recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Taizhou, Zhejiang, China, 318000
        • Not yet recruiting
        • Taizhou central hospital(Taizhou university hospital)
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • Wenzhou Medical University Affiliated Second Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQC2731 injection
TQC2731 injection, 4 weeks as a treatment cycle. Study drug administration from Day 0 up to Week 48.
Drug: TQC2731 injection
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.
Placebo Comparator: Placebo
Placebo,4 weeks as a treatment cycle.Study drug administration from Day 0 up to Week 48.
Drug: Placebo
Placebo without drug substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the first day of dosing to the completion of 52 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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).
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 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.
From baseline to week 52
Change in Asthma Control Questionnaire-6 (ACQ-6) score
Time Frame: From baseline to week 52
Mean change from baseline in weekly mean asthma symptom diary score at week 52, , The higher the score, the more severe the asthma symptoms.
From baseline to week 52
Mean change in weekly mean asthma symptom diary score
Time Frame: From baseline to week 52
Mean change from baseline in weekly mean asthma symptom diary score at week 52
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 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.
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
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
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
Change from baseline in exhaled nitric oxide FENO (ppb) at week 52.
From baseline to week 52
Changes in peripheral blood eosinophils
Time Frame: From baseline to week 52
Change from baseline in peripheral blood eosinophils at week 52.
From baseline to week 52
Changes in total serum IgE
Time Frame: From baseline to week 52
Change from baseline in total serum IgE at week 52.
From baseline to week 52
Time to first asthma exacerbation
Time Frame: Baseline to week 64
Time to first asthma exacerbation
Baseline to week 64
Proportion of subjects with ≥1 asthma exacerbation
Time Frame: Baseline to week 64
Proportion of subjects with ≥1 asthma exacerbation
Baseline to week 64
Number of days of glucocorticoid use due to acute exacerbations
Time Frame: Baseline to week 64
Number of days of glucocorticoid use due to acute exacerbations
Baseline to week 64
Average amount of hormone used per acute exacerbation (prednisone equivalent)
Time Frame: Baseline to week 64
Average amount of hormone used per acute exacerbation (prednisone equivalent)
Baseline to week 64
Incidence of anti-drug antibodies (ADAs) in subjects
Time Frame: Baseline to week 64
Immunogenicity: Incidence of anti-drug antibodies (ADAs) in subjects and their titers.
Baseline to week 64
Incidence of neutralizing antibodies(NAB) in subjects
Time Frame: Baseline to week 64
Immunogenicity: Incidence of neutralizing antibodies (NAB).
Baseline to week 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 30, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQC2731-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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