TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Launched by SHANGHAI CHIA TAI TIANQING PHARMACEUTICAL TECHNOLOGY DEVELOPMENT CO., LTD. · Feb 12, 2025

Keywords

ClinConnect Summary

The TQC2731 Clinical Trial is a research study looking at a new injection called TQC2731 to see if it can help adults with severe asthma who are having trouble controlling their symptoms. This study is taking place at multiple locations and will involve about 660 participants. People in the trial will be randomly assigned to receive either the TQC2731 injection or a placebo, which is a treatment that doesn’t contain the active drug. The injections will be given once every four weeks.

To participate, individuals need to be between 18 and 75 years old and have been diagnosed with asthma for at least a year. They should also have been on high doses of asthma medication for at least six months and have experienced at least two asthma flare-ups in the past year. Before joining, participants will need to sign a form that explains the study and its potential risks. Those who have other serious lung diseases, autoimmune conditions, or certain cancer histories may not be eligible. If you join the study, you will help researchers understand how effective and safe TQC2731 is for treating severe asthma, which could lead to better treatments in the future.

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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.