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The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 | Drug | SHR-1314 high dose |
| |
| SHR-1314 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Responded for ASAS 20 Response at 32 Weeks | 32 Weeks | |
| Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks | 16 and 32 Weeks | |
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Inclusion Criteria:
- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs
Exclusion Criteria:
- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42101839 | Derived | Zhu J, Zhao C, Mi C, Liu S, Wu R, Li T, Duan X, Sun L, Yang L, He X, Liu W, Li Y, Ma L, Du H, Liu Y, Chen G, Zhang H, Wang T, Liu X, Shi X, Liu J, Wu H, Sun H, Xue Y, Chai K, Li H, Hu J, Dong F, Lin L, Du Q, Bai X, Huang F. Vunakizumab for Radiographic Axial Spondyloarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2611632. doi: 10.1001/jamanetworkopen.2026.11632. |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| Drug |
SHR-1314 low-dose |
|
| Placebo | Drug | Placebo |
|
| Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks |
| 16 and 32 Weeks |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks | 16 and 32 Weeks |
| Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks | 16 and 32 Weeks |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |