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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Sign the willing to sign a consent form 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. Who Should NOT Join This Trial: - Have a clinically significant lung disease other than asthma; - Pre-existing autoimmune conditions (where your immune system attacks your own body); - 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); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

DRUG

Placebo

Placebo without drug substance.

Locations (20)

The People's Hospital of Bozhou
Bozhou, Anhui, China
Anhui Chest Hoispital
Hefei, Anhui, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Third People's Hospital of Huizhou
Huizhou, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
The Affiliated Hospital of Medical University
Guilin, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Cangzhou Hospital of Integrated TCM-WM·Hebei
Cangzhou, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
Da Qing Long Nan Hospital
Daqing, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Qiqihar First People's Hospital
Qiqihar, Heilongjiang, China
The Second People's Hospital of Jiaozuo City
Jiaozuo, Henan, China
Luo Yang Dong Fang People's Hospital
Luoyang, Henan, China
Zhoukou Central hospital
Zhoukou, Henan, China