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Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma
Sponsor: Qilu Pharmaceutical Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
636
Start Date
2025-12-25
Completion Date
2029-12
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
tezepelumab (Arm1&Arm2)
210mg Q4W (Arm1\&Arm2)