TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection
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
1 other identifier
interventional
660
1 country
74
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Mar 2025
Typical duration for phase_3 asthma
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
February 17, 2025
CompletedStudy Start
First participant enrolled
March 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 1, 2025
November 1, 2024
2.2 years
February 12, 2025
March 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized incidence of asthma exacerbations
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 Outcomes (15)
The change in forced expiratory volume in 1 second (FEV1)
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
From baseline to week 52
Change in Asthma Control Questionnaire-6 (ACQ-6) score
From baseline to week 52
Mean change in weekly mean asthma symptom diary score
From baseline to week 52
Change in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score
From baseline to week 52
- +10 more secondary outcomes
Study Arms (2)
TQC2731 injection
EXPERIMENTALTQC2731 injection, 4 weeks as a treatment cycle. Study drug administration from Day 0 up to Week 48.
Placebo
PLACEBO COMPARATORPlacebo,4 weeks as a treatment cycle.Study drug administration from Day 0 up to Week 48.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
The People's Hospital of Bozhou
Bozhou, Anhui, 236000, China
Anhui Chest Hoispital
Hefei, Anhui, 230022, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Third People's Hospital of Huizhou
Huizhou, Guangdong, 516002, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403, China
The Affiliated Hospital of Medical University
Guilin, Guangxi, 541000, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000, China
Cangzhou Hospital of Integrated TCM-WM·Hebei
Cangzhou, Hebei, 061000, China
Xingtai People's Hospital
Xingtai, Hebei, 054001, China
Da Qing Long Nan Hospital
Daqing, Heilongjiang, 163453, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Qiqihar First People's Hospital
Qiqihar, Heilongjiang, 161000, China
The Second People's Hospital of Jiaozuo City
Jiaozuo, Henan, 454001, China
Luo Yang Dong Fang People's Hospital
Luoyang, Henan, 471003, China
Zhoukou Central hospital
Zhoukou, Henan, 466000, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430000, China
Changsha Central Hospital
Changsha, Hunan, 410000, China
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, Hunan, 410021, China
Loudi central hospital
Loudi, Hunan, 417000, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014040, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, 14000, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024099, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 100000, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 100017, China
The Second People Hospital's of Lianyungang
Lianyungang, Jiangsu, 222006, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, 212001, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Jilin University Second Hospital
Changchun, Jilin, 130000, China
The First Hospital of Jlin University
Changchun, Jilin, 130000, China
Gansu Provincial Hospital
Gansu, Lanzhou, 730000, China
Dalian Municipal Central Hospital
Dalian, Liaoning, 116021, China
Genertec Liaoyou Gem Flower Hospital
Panjin, Liaoning, 124000, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000, China
People's Liberation Army North Theater General Hospital
Shenyang, Liaoning, 130012, China
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, 750001, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
The First Affiliated Hospital of Xi'an Medical Universi
Xi'an, Shaanxi, 710000, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710000, China
Heze Municipal Hospital
Heze, Shandong, 274031, China
Affiliated Hospital of Jining Medical Hospital
Jining, Shandong, 272000, China
Weifang NO.2 People's Hospital
Weifang, Shandong, 261041, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277000, China
Rui Jin Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, 200025, China
Fudan University Affiliated Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai Municipality, 200120, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200336, China
Wusong Central Hospital, Baoshan District, Shanghai
Shanghai, Shanghai Municipality, 200940, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Yangquan Coal Industry Group General Hospital
Yangquan, Shanxi, 45000, China
Suining Central Hospital
Suining, Sichuan, 629000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin 4th Center Hospital
Tianjin, Tianjin Municipality, 300140, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832008, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Xinjiang Uiger Municipal People'S Hospital
Ürümqi, Xinjiang, 830000, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650000, China
The People's Hospital of Yuyao
Yuyao, Zhejaing, 315400, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020, China
Taizhou Central Hospital(Taizhou University Hospital)
Taizhou, Zhejiang, 318000, China
Wenzhou Medical University Affiliated Second Hospital
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2025
First Posted
February 17, 2025
Study Start
March 21, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
April 1, 2025
Record last verified: 2024-11