Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tezepelumab (Arm1&Arm2).
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Biological tezepelumab (Arm1&Arm2)
210mg Q4W (Arm1\&Arm2)
Primary outcome measures
- Primary endpoint ： [Time frame: 52 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Pulmonary disease other than asthma.
- History of cancer within 5 years except those cured.
- History of a clinically significant infection within 4 weeks.
- Current smokers or participants with smoking history ≥10 pack-yrs.
- History of chronic alcohol or drug abuse within 12 months.
- Positive Hepatitis B, C or HIV infection.
- Pregnant or breastfeeding.
- History of anaphylaxis following any biologic therapy.
- Participant received tezepelumab or other TSLP antibody priorly.
- Participant received bronchial thermoplasty within 12 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07302516 · QL2302-301