NCT07302516Not yet recruitingPhase 3
Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma
A Multi-center, Randomised, Double Blind, Active Controlled Phase III Trial to Compare the Efficacy and Safety of QL2302 With Tezspire® in Adults With Uncontrolled Severe Asthma
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
The goal of this clinical trial is to compare the efficacy and safety of QL2302 and Tezspire® in patients with uncontrolled severe asthma. The main questions it aims to answer are: * if the efficacy of QL2302 and Tezspire® are similar * if the safety of QL2302 and Tezspire® are similar Participants will be randomised to QL2302 or Tezspire® group and asked to receive one injection of QL2302 or Tezspire® 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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 636 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 25 Dec 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Asthma
- NCT number
- NCT07302516
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 636
- From 25 Dec 2025 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant received tezepelumab or other TSLP antibody priorly.
- Participant received bronchial thermoplasty within 12 months.
Other illness
- Pulmonary disease other than asthma.
- History of cancer within 5 years except those cured.
- History of a clinically significant infection within 4 weeks.
- History of chronic alcohol or drug abuse within 12 months.
- Positive Hepatitis B, C or HIV infection.
- History of anaphylaxis following any biologic therapy.
Other
- Current smokers or participants with smoking history ≥10 pack-yrs.
- Pregnant or breastfeeding.
Who the study is looking for
- 18-80 year of age
- Body weight ≥40 kg
- Diagnosed with asthma ≥12 months
- Received a total daily dose of medium/high dose of ICS for more than 3 months steadily
- 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.
- Morning pre-BD FEV1 \<80% but ≥35% predicted normal
- Evidence of asthma as documented by reversibility test or change of PEF.
- Documented history of at least 1 asthma exacerbation events within 12 months.
- ACQ-5 score ≥1.5 at screening and on day of randomization
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.