Treatment for severe asthma using TQC2731 injection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Wusong Central Hospital, Baoshan District, Shanghai
  Shanghai, Shanghai Municipality, China Recruiting
• 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 Anhui Medical University
  Hefei, Anhui, China Not yet recruiting
• Lu'an People's Hospital of Anhui Province
  Lu'an, Anhui, China Not yet recruiting

+51 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Jinping Zheng, Doctor
• Email: jpzhenggy@163.com
• Phone: 18928868238

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.