TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection (NCT06829784) | Clinical Trial Compass
RecruitingPhase 3
TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection
China660 participantsStarted 2025-03-21
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ar…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 3, which means TQC2731 has already been tested in earlier studies — can you tell me what was learned about its safety and effectiveness in those earlier phases before I consider this option?
2Since the trial measures how often severe asthma attacks happen over time, how long would I need to stay enrolled, and how would that commitment fit with managing my day-to-day asthma care?
3The trial involves injections — can you explain how often I would need to come in for those injections, and whether any part of this could be done closer to home or would require travel to a specific study site?
4Are there already approved injectable biologic treatments for severe asthma, like dupilumab or mepolizumab, that I should consider trying first before looking at a trial like this one?
5If I join this trial and my asthma gets worse or I have a serious flare-up, what would happen — would I be able to access rescue medications or switch to a standard treatment without losing my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Annualized incidence of asthma exacerbations
Timeframe: From the first day of dosing to the completion of 52 weeks of treatment
Trial details
NCT IDNCT06829784
SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.