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This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).
Approximately 258 eligible subjects (129 per arm) will be randomized in a 1:1 ratio to Jaktinib 100mg BID (twice daily) or matching placebo BID for a total of 16 weeks of blinded treatment. During the 16-week treatment period subjects will visit the clinic every two weeks until the Week 4 visit and then every 4 weeks until the completion of Week 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib 100mg BID (twice daily) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib | Drug | Participants will receive 100 mg Jaktinib orally twice daily for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 16 | ASAS40 is defined as a >= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16. | ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunde Bao | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital | Shanghai | Shanghai Municipality | 200001 | China |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| Placebo | Drug | Participants will receive matching placebo orally twice daily for 16 weeks |
|
| Week 16 |
| Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 2、4、8 and 12. | ASAS40 is defined as a >= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain. | Week 2、4、8 and 12 |
| Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 2、4、8 and 12. | ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10]) | Week 2、4、8 and 12 |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |