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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL2302 | Experimental |
| |
| Tezspire® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tezepelumab (Arm1&Arm2) | Biological | 210mg Q4W (Arm1&Arm2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint : | Annualized Asthma Exacerbation Rate (AAER) | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Zhang, PhD | Contact | 13482345145 | 13482345145@163.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000622721 | tezepelumab |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |