AsthmaPhase 3NCT07302516
Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma
A Phase 3 study testing tezepelumab (Arm1&Arm2) in people with Asthma, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- tezepelumab (Arm1&Arm2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 636 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2025to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Asthma
- Being tested
- tezepelumab (Arm1&Arm2)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tezepelumab (Arm1&Arm2)Biological
210mg Q4W (Arm1\&Arm2)
| Study group | Role | What they receive |
|---|---|---|
| QL2302 | Experimental | Not described Receives: Biological: tezepelumab (Arm1&Arm2) |
| Tezspire® | Active comparator | Not described Receives: Biological: tezepelumab (Arm1&Arm2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint ：
Annualized Asthma Exacerbation Rate (AAER)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start25 Dec 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302516
- Sponsor's protocol ID
- QL2302-301
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07302516
- Acronym / sponsor ID
- QL2302-301
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL2302 | Experimental | Biological: tezepelumab (Arm1&Arm2) |
| Tezspire® | Active comparator | Biological: tezepelumab (Arm1&Arm2) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tezepelumab (Arm1&Arm2)210mg Q4W (Arm1\&Arm2) | Biological | QL2302, Tezspire® |
Primary outcome
Primary endpoint ：
Time frame: 52 weeks
Annualized Asthma Exacerbation Rate (AAER)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tezepelumab (Arm1&Arm2) in people with Asthma, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Zhang, PhD (13482345145, 13482345145@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint ： (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.