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The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1314 Injection | Experimental | Subjects will receive SHR-1314 injection in the core treatment period and the extended treatment period. |
|
| SHR-1314 Placebo Injection | Placebo Comparator | Subjects will receive SHR-1314 placebo injection in the core treatment period and receive SHR-1314 injection in the extended treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 Injection | Drug | SHR-1314 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score). | At the 16th week after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving ASAS 20 (ankylosing spondylitis disease activity score). | At the 16th week after administration. | |
| Change in CRP (C-reactive protein) value from baseline. | At the 16th week after administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihua Lin | Contact | +86-0518-82342973 | lihua.lin.ll12@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100039 | China |
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| SHR-1314 Placebo Injection | Drug | SHR-1314 placebo injection. |
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| AEs (adverse events). | Up to 60 weeks after administration. |