Clinical trial NCT06829784: TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Annualized incidence of asthma exacerbations
timeFrame: From the first day of dosing to the completion of 52 weeks of treatment
Secondary outcomes:
measure: The change in forced expiratory volume in 1 second (FEV1)
timeFrame: Week 52 before dosing and before the use of bronchodilators (pre-Bronchodilator (pre-BD) administration)
measure: Change in total score of standardized asthma quality of life questionnaire
timeFrame: From baseline to week 52
measure: Change in Asthma Control Questionnaire-6 (ACQ-6) score
timeFrame: From baseline to week 52
measure: Mean change in weekly mean asthma symptom diary score
timeFrame: From baseline to week 52
measure: Change in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score
timeFrame: From baseline to week 52
measure: Change in mean rescue medication use, average peak expiratory flow rate (PEF) in the morning and night
timeFrame: From baseline to week 52
measure: Changes in exhaled nitric oxide Fractional exhaled nitric oxide (FENO) (ppb), peripheral blood eosinophils, total serum Immunoglobulin E (IgE).
timeFrame: From baseline to week 52
measure: Changes in peripheral blood eosinophils
timeFrame: From baseline to week 52
measure: Changes in total serum IgE
timeFrame: From baseline to week 52
measure: Time to first asthma exacerbation
timeFrame: Baseline to week 64
measure: Proportion of subjects with ≥1 asthma exacerbation
timeFrame: Baseline to week 64
measure: Number of days of glucocorticoid use due to acute exacerbations
timeFrame: Baseline to week 64
measure: Average amount of hormone used per acute exacerbation (prednisone equivalent)
timeFrame: Baseline to week 64
measure: Incidence of anti-drug antibodies (ADAs) in subjects
timeFrame: Baseline to week 64
measure: Incidence of neutralizing antibodies(NAB) in subjects
timeFrame: Baseline to week 64
Other outcomes:
Locations:
city: Bozhou
country: China
facility: The People's Hospital of Bozhou
state: Anhui
city: Hefei
country: China
facility: Anhui Chest Hoispital
state: Anhui
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Huizhou
country: China
facility: Third People's Hospital of Huizhou
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
city: Guilin
country: China
facility: The Affiliated Hospital of Medical University
state: Guangxi
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Cangzhou
country: China
facility: Cangzhou Hospital of Integrated TCM-WM·Hebei
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Daqing
country: China
facility: Da Qing Long Nan Hospital
state: Heilongjiang
city: Ha'erbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Qiqihar
country: China
facility: Qiqihar First People's Hospital
state: Heilongjiang
city: Jiaozuo
country: China
facility: The Second People's Hospital of Jiaozuo City
state: Henan
city: Luoyang
country: China
facility: Luo Yang Dong Fang People's Hospital
state: Henan
city: Zhoukou
country: China
facility: Zhoukou Central hospital
state: Henan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
state: Hunan
city: Loudi
country: China
facility: Loudi central hospital
state: Hunan
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
state: Inner Mongolia
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region People's Hospital
state: Inner Mongolia
city: Lianyungang
country: China
facility: The Second People Hospital's of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Jiangsu University Affiliated Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin University Second Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jlin University
state: Jilin
city: Gansu
country: China
facility: Gansu Provincial Hospital
state: Lanzhou
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Panjin
country: China
facility: Genertec Liaoyou Gem Flower Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: People's Liberation Army North Theater General Hospital
state: Liaoning
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical Universi
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang NO.2 People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiaotong University School of Medical
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Affiliated Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
city: Shanghai
country: China
facility: Wusong Central Hospital, Baoshan District, Shanghai
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Yangquan
country: China
facility: Yangquan Coal Industry Group General Hospital
state: Shanxi
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin 4th Center Hospital
state: Tianjin
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University
state: Xinjiang
city: Ürümqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: Xinjiang Uiger Municipal People'S Hospital
state: Xinjiang
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Yuyao
country: China
facility: The People's Hospital of Yuyao
state: Zhejaing
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital(Taizhou University Hospital)
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Medical University Affiliated Second Hospital
state: Zhejiang
Study officials:
References: