Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma
NCT ID: NCT07302516
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
636 participants
INTERVENTIONAL
2025-12-25
2029-12-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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QL2302
tezepelumab (Arm1&Arm2)
210mg Q4W (Arm1\&Arm2)
Tezspire®
tezepelumab (Arm1&Arm2)
210mg Q4W (Arm1\&Arm2)
Interventions
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tezepelumab (Arm1&Arm2)
210mg Q4W (Arm1\&Arm2)
Eligibility Criteria
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Inclusion Criteria
2. Body weight ≥40 kg
3. Diagnosed with asthma ≥12 months
4. Received a total daily dose of medium/high dose of ICS for more than 3 months steadily
5. 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.
6. Morning pre-BD FEV1 \<80% but ≥35% predicted normal
7. Evidence of asthma as documented by reversibility test or change of PEF.
8. Documented history of at least 1 asthma exacerbation events within 12 months.
9. ACQ-5 score ≥1.5 at screening and on day of randomization
Exclusion Criteria
2. History of cancer within 5 years except those cured.
3. History of a clinically significant infection within 4 weeks.
4. Current smokers or participants with smoking history ≥10 pack-yrs.
5. History of chronic alcohol or drug abuse within 12 months.
6. Positive Hepatitis B, C or HIV infection.
7. Pregnant or breastfeeding.
8. History of anaphylaxis following any biologic therapy.
9. Participant received tezepelumab or other TSLP antibody priorly.
10. Participant received bronchial thermoplasty within 12 months.
18 Years
80 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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QL2302-301
Identifier Type: -
Identifier Source: org_study_id