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New treatment option for Asthma
Official title TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection
ClinicalTrials.gov ID: NCT06829784
What this study is testing
What is TQC2731 injection?
TQC2731 injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
- people who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to...
- There must be a record of receiving a stable total daily dose of ICS at least 3 months prior to visit 1;
You likely can't join if
- 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...
- Current smoker or smoking history ≥10 pack-years (former smokers with smoking history \<10 pack-years had quit smoking less than 6 months before...
See the full eligibility 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;
- people 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 people taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone...
- 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.
- 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...
- 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 people were not suitable to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Bozhou, Anhui, China
- Hefei, Anhui, China
- Lu'an, Anhui, China
- Tongling, Anhui, China
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Zhangzhou, Fujian, China
- Lanzhou, Gansu, China
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
- Huizhou, Guangdong, China
- Zhongshan, Guangdong, China
- Guilin, Guangxi, China
- Guiyang, Guizhou, China
- Haikou, Hainan, China
- Cangzhou, Hebei, China
- Xingtai, Hebei, China
- Daqing, Heilongjiang, China
- Harbin, Heilongjiang, China
- Qiqihar, Heilongjiang, China
+ 53 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bozhou, Anhui, China; Hefei, Anhui, China; Lu'an, Anhui, China; Tongling, Anhui, China; Beijing, Beijing Municipality, China; Xiamen, Fujian, China and 67 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.