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

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07302516
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • tezepelumab (Arm1&Arm2) — BIOLOGICAL
    210mg Q4W (Arm1\&Arm2)

Study Details

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.

Key Dates

First listed
Dec 24, 2025
Start date
Dec 25, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
636 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL2302
  • Active Comparator: Tezspire®

Primary Outcome Measure

Primary endpoint ： [ Time Frame: 52 weeks ]

Central Contacts

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