Trials / Not Yet Recruiting
Not Yet RecruitingNCT07302516
Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma
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
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 636 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | tezepelumab (Arm1&Arm2) | 210mg Q4W (Arm1\&Arm2) |
Timeline
- Start date
- 2025-12-25
- Primary completion
- 2028-12-01
- Completion
- 2029-12-01
- First posted
- 2025-12-24
- Last updated
- 2025-12-24
Source: ClinicalTrials.gov record NCT07302516. Inclusion in this directory is not an endorsement.