Treatment for severe asthma using TQC2731 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

This study is testing if an injection called TQC2731 can help adults with severe asthma who aren't getting enough control from their current treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 74 sites (Bozhou, Anhui and 73 other locations)
• Trial ID: NCT06829784 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of TQC2731 injection administered every four weeks in adults with inadequately controlled severe asthma. The study is multicenter, randomized, double-blind, and placebo-controlled, involving 660 participants who will be assigned in a 1:1 ratio to receive either the TQC2731 injection or a placebo. Participants must have a documented history of asthma and have been on high-dose inhaled corticosteroids prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a documented diagnosis of severe asthma and a history of exacerbations despite high-dose inhaled corticosteroid treatment.

Not a fit: Patients with mild or well-controlled asthma, or those not meeting the specific inclusion criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve asthma control for patients with severe asthma who are not adequately managed with current therapies.

How similar studies have performed: Other studies have shown promise in treating severe asthma with similar approaches, indicating potential for success in this trial.

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.

Where this trial is running

Bozhou, Anhui and 73 other locations

• The People's Hospital of Bozhou — Bozhou, Anhui, China (Not_yet_recruiting)
• Anhui Chest Hoispital — Hefei, Anhui, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• Lanzhou University Second Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guangzhou First People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Third People's Hospital of Huizhou — Huizhou, Guangdong, China (Not_yet_recruiting)
• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (Not_yet_recruiting)
• The Affiliated Hospital of Medical University — Guilin, Guangxi, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Cangzhou Hospital of Integrated TCM-WM·Hebei — Cangzhou, Hebei, China (Not_yet_recruiting)
• Xingtai People's Hospital — Xingtai, Hebei, China (Not_yet_recruiting)
• Da Qing Long Nan Hospital — Daqing, Heilongjiang, China (Not_yet_recruiting)
• The Fourth Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Qiqihar First People's Hospital — Qiqihar, Heilongjiang, China (Not_yet_recruiting)
• The Second People's Hospital of Jiaozuo City — Jiaozuo, Henan, China (Not_yet_recruiting)
• Luo Yang Dong Fang People's Hospital — Luoyang, Henan, China (Not_yet_recruiting)
• Zhoukou Central hospital — Zhoukou, Henan, China (Not_yet_recruiting)
• The Central Hospital of Wuhan — Wuhan, Hubei, China (Not_yet_recruiting)
• Changsha Central Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) — Changsha, Hunan, China (Not_yet_recruiting)
• Loudi central hospital — Loudi, Hunan, China (Not_yet_recruiting)
• Baotou Central Hospital — Baotou, Inner Mongolia, China (Not_yet_recruiting)
• The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology — Baotou, Inner Mongolia, China (Not_yet_recruiting)
• Chifeng Municipal Hospital — Chifeng, Inner Mongolia, China (Not_yet_recruiting)
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• Inner Mongolia Autonomous Region People's Hospital — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• The Second People Hospital's of Lianyungang — Lianyungang, Jiangsu, China (Not_yet_recruiting)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Not_yet_recruiting)
• Jiangsu University Affiliated Hospital — Zhenjiang, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Pingxiang People's Hospital — Pingxiang, Jiangxi, China (Not_yet_recruiting)
• Jilin University Second Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• The First Hospital of Jlin University — Changchun, Jilin, China (Not_yet_recruiting)
• Gansu Provincial Hospital — Gansu, Lanzhou, China (Not_yet_recruiting)
• Dalian Municipal Central Hospital — Dalian, Liaoning, China (Not_yet_recruiting)
• Genertec Liaoyou Gem Flower Hospital — Panjin, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• People's Liberation Army North Theater General Hospital — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First People's Hospital of Yinchuan — Yinchuan, Ningxia, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Medical Universi — Xi'an, Shaanxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Xi'an International Medical Center Hospital — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Heze Municipal Hospital — Heze, Shandong, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jinping Zheng, Doctor

Conditions Asthma