Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma

December 11, 2025 updated by: Qilu Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

636

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL2302
Biological: tezepelumab (Arm1&Arm2)
210mg Q4W (Arm1&Arm2)
Active Comparator: Tezspire®
Biological: tezepelumab (Arm1&Arm2)
210mg Q4W (Arm1&Arm2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint ：
Time Frame: 52 weeks
Annualized Asthma Exacerbation Rate (AAER)
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL2302-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on tezepelumab (Arm1&Arm2)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe