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Clinical Trials in China / NCT06829784
Recruiting Phase 3

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

NCT06829784 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Phase
Phase 3
Started
2025-03-21
Last updated
2026-08-19

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

TQC2731 injectionPlacebo

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: Placebo without drug substance.

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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (101)

FacilityCityRegionStatus
The People's Hospital of Bozhou Bozhou Anhui Not Yet Recruiting
Anhui Chest Hoispital Hefei Anhui Not Yet Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Not Yet Recruiting
Lu'an People's Hospital of Anhui Province Lu'an Anhui Not Yet Recruiting
Tongling People's Hospital Tongling Anhui Not Yet Recruiting
Peking University First Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing No.6 Hospital Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Not Yet Recruiting
Zhangzhou Municipal Hospital of Fujian Zhangzhou Fujian Not Yet Recruiting
The First Hospital of Lanzhou University Lanzhou Gansu Not Yet Recruiting
The Second Hospital & Clinical Medical School,Lanzhou University Lanzhou Gansu Not Yet Recruiting
The Eighth Afliated Hospital of Southern Medical University The First people's Hospital of Shunde Foshan Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine Guangzhou Guangdong Not Yet Recruiting
Guangzhou First People's Hospital Guangzhou Guangdong Not Yet Recruiting
Third People's Hospital of Huizhou Huizhou Guangdong Not Yet Recruiting
Zhongshan City People's Hospital Zhongshan Guangdong Not Yet Recruiting
The Affiliated Hospital of Medical University Guilin Guangxi Not Yet Recruiting
Guilin People'S Hospital Guilin Guangxi Not Yet Recruiting
Guizhou Provincial People's Hospital Guiyang Guizhou Not Yet Recruiting
The First Affiliated Hospital of Hainan Medical University Haikou Hainan Not Yet Recruiting
Cangzhou Hospital of Integrated TCM-WM·Hebei Cangzhou Hebei Not Yet Recruiting
Xingtai People's Hospital Xingtai Hebei Not Yet Recruiting
Da Qing Long Nan Hospital Daqing Heilongjiang Not Yet Recruiting
The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Not Yet Recruiting
The First Hospital of Qiqihar Qiqihar Heilongjiang Not Yet Recruiting
The People's Hospital of Anyang Anyang Henan Not Yet Recruiting
The Second People's Hospital of Jiaozuo City Jiaozuo Henan Not Yet Recruiting
Luo Yang Dong Fang People's Hospital Luoyang Henan Not Yet Recruiting
Xinxiang Central Hospital Xinxiang Henan Not Yet Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
Zhengzhou Central Hospital Zhengzhou Henan Not Yet Recruiting
Zhoukou Central hospital Zhoukou Henan Not Yet Recruiting
Enshi Tujia and Miao Autonomous Prefecture Central Hospital Enshi Hubei Not Yet Recruiting
The Central Hospital of Wuhan Wuhan Hubei Not Yet Recruiting
Changsha Central Hospital Changsha Hunan Not Yet Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) Changsha Hunan Not Yet Recruiting
Loudi central hospital Loudi Hunan Not Yet Recruiting
Baotou Central Hospital Baotou Inner Mongolia Not Yet Recruiting

+ 61 more sites — see the full list on the official registry below.

More Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06829784 on ClinicalTrials.gov ↗ ← All trials in China