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

NCT07302516 | Not Yet Recruiting Phase 3

• 1 other identifier: QL2302-301
• Study Type: interventional
• Target: 636
• Locations: 0 countries
• Sites: N/A

Brief 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

Asthma

Outcome Measures

Primary Outcomes (1)

• Primary endpoint ：

  Annualized Asthma Exacerbation Rate (AAER)

  52 weeks

Study Arms (2)

QL2302

EXPERIMENTAL

Biological: tezepelumab (Arm1&Arm2)

Tezspire®

ACTIVE COMPARATOR

Biological: tezepelumab (Arm1&Arm2)

Interventions

tezepelumab (Arm1&Arm2) BIOLOGICAL

210mg Q4W (Arm1\&Arm2)

QL2302; Tezspire®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year of age
• Body weight ≥40 kg
• Diagnosed with asthma ≥12 months
• Received a total daily dose of medium/high dose of ICS for more than 3 months steadily
• 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.
• Morning pre-BD FEV1 \<80% but ≥35% predicted normal
• Evidence of asthma as documented by reversibility test or change of PEF.
• Documented history of at least 1 asthma exacerbation events within 12 months.
• ACQ-5 score ≥1.5 at screening and on day of randomization

You may not qualify if:

• Pulmonary disease other than asthma.
• History of cancer within 5 years except those cured.
• History of a clinically significant infection within 4 weeks.
• Current smokers or participants with smoking history ≥10 pack-yrs.
• History of chronic alcohol or drug abuse within 12 months.
• Positive Hepatitis B, C or HIV infection.
• Pregnant or breastfeeding.
• History of anaphylaxis following any biologic therapy.
• Participant received tezepelumab or other TSLP antibody priorly.
• Participant received bronchial thermoplasty within 12 months.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Min Zhang, PhD

CONTACT

13482345145; 13482345145@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12