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New asthma drug QL2302 goes Head-to-Head with tezspire in major trial

NCT ID NCT07302516

Disease control Sponsor: Qilu Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new drug called QL2302 works as well as the approved drug Tezspire for people with severe asthma that is not controlled by current treatments. About 636 adults aged 18-80 will receive injections every 4 weeks for 48 weeks, then be monitored for another 12 weeks. The main goal is to see if QL2302 can reduce asthma attacks as effectively as Tezspire.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 636 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18-80 year of age 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: 1. Pulmonary disease other than asthma. 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.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.