Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR0302 |
|
| Treatment group B | Placebo Comparator | SHR0302 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | SHR0302, oral, once daily |
| |
| SHR0302 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12 | Week 12 | |
| Percentage of Participants With ASAS 20 Response at week 12 | Week 12 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuan Zhang | Contact | (+86)13436522766 | zxlab@outlook.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000089202 | Non-Radiographic Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
Not provided
Not provided
| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
Not provided
Not provided
Not provided
SHR0302 compared with placebo
Not provided
Not provided
Not provided
| Drug |
SHR0302 placebo, oral, once daily |
|
| Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 |
| Week 12 |
| Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24 | Week 12 and Week 24 |
| Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24 | Week 12 and Week 24 |
| Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24 | Week 12 and Week 24 |
| Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24 | Week 12 and Week 24 |
| Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24 | Week 12 and Week 24 |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |