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The goal of this clinical trial is to To evaluate the efficacy of subcutaneous (SC) Netakimab in adult Chinese patients with Active Ankylosing Spondylitis. Researchers will compare Netakimab to placebo to see if Netakimab works to treat Ankylosing Spondylitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netakimab | Experimental | Netakimab administered by subcutaneous injection until Week 52 |
|
| Placebo | Placebo Comparator | Placebo administered by subcutaneous injection until Week 16 then Netakimab subcutaneous injection until 52 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netakimab | Drug | Netakimab administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving ASAS40 | Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 16. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving ASAS20 | Proportion of patients achieving 20% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 2, 4, 8, 12, 16, 24, 36, and 52. | at Week 2, 4, 8, 12, 16, 24, 36, and 52. |
| Proportion of patients achieving ASAS40 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
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| Placebo |
| Drug |
Placebo administered subcutaneously |
|
Proportion of patients achieving 40% improvement criteria established by the International Ankylosing Spondylitis Assessment Task Force at Week 2, 4, 8, 12, 24, 36, and 52. |
| at Week 2, 4, 8, 12, 24, 36, and 52 |
| Proportion of patients achieving ASAS5/6 | Proportion of patients achieving ASAS5/6 at Week 2, 4, 8, 12, 16, 24, 36, and 52. | at Week 2, 4, 8, 12, 16, 24, 36, and 52 |
| Change from baseline in BASDAI | Change from baseline in BASDAI at Week 2, 4, 8, 12, 16, 24, 36, and 52. | at Week 2, 4, 8, 12, 16, 24, 36, and 52. |
| Change from baseline in BASMI | Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 2, 4, 8, 12, 16, 24, 36, and 52 | at Week 2, 4, 8, 12, 16, 24, 36, and 52 |
| Change from baseline in BASFI | Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 2, 4, 8, 12, 16, 24, 36, and 52. | at Week 2, 4, 8, 12, 16, 24, 36, and 52 |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| C000718740 | netakimab |
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