Compare the Efficacy and Safety of QL2302 Versus TezspireĀ® in Severe Asthma (NCT07302516) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Compare the Efficacy and Safety of QL2302 Versus TezspireĀ® in Severe Asthma
636 participantsStarted 2025-12-25
Plain-language summary
The goal of this clinical trial is to compare the efficacy and safety of QL2302 and TezspireĀ® in patients with uncontrolled severe asthma. The main questions it aims to answer are:
* if the efficacy of QL2302 and TezspireĀ® are similar
* if the safety of QL2302 and TezspireĀ® are similar
Participants will be randomised to QL2302 or TezspireĀ® group and asked to receive one injection of QL2302 or TezspireĀ® subcutaneously every four weeks till Week 48, which means participants will receive a total of 13 injections. And be observed for another 12 weeks after the end of treatment.
Who can participate
Age range18 Years ā 80 Years
SexALL
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
ā. 18-80 year of age
ā. Body weight ā„40 kg
ā. Diagnosed with asthma ā„12 months
ā. Received a total daily dose of medium/high dose of ICS for more than 3 months steadily
ā. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
ā. Morning pre-BD FEV1 \<80% but ā„35% predicted normal
ā. Evidence of asthma as documented by reversibility test or change of PEF.
ā. Documented history of at least 1 asthma exacerbation events within 12 months.
Exclusion criteria
ā. Pulmonary disease other than asthma.
ā. History of cancer within 5 years except those cured.
ā. History of a clinically significant infection within 4 weeks.
ā. Current smokers or participants with smoking history ā„10 pack-yrs.
ā. History of chronic alcohol or drug abuse within 12 months.