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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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This is a multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo(JS005) | Experimental |
| |
| Recombinant humanized IL-17A Monoclonal Antibody(JS005)150mg | Experimental |
| |
| Recombinant humanized IL-17A Monoclonal Antibody(JS005)300mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant humanized IL-17A Monoclonal Antibody(JS005) | Drug | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of SpondyloArthritis International Society criteria (ASAS)40 | Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS)40 response criteria at week 16. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of SpondyloArthritis International Society criteria (ASAS)40 | Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS)40 response criteria at week 32. | 32 weeks |
| Assessment of SpondyloArthritis International Society criteria (ASAS)20 |
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Inclusion Criteria:
Exclusion Criteria:
4. Active inflammatory bowel disease within 6 months prior to randomization. 5. Recurrent anterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization.
6. History or evidence of active or latent tuberculosis (TB), defined as a positive interferon gamma release assay (IGRA) or purified protein derivative (PPD) at the time of screening. 7. Positive hepatitis B virus test result 8. Prior exposure to JS005 or any other biologic that directly targets IL-17 or the IL-17 receptor.
9. use of >= 2 TNF-α inhibitors.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiexin Hu | Contact | 13521183167 | jiexin_hu@junshipharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Huji Xu, PhD | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-yang Hospital,Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100020 | China |
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Parallel
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| Placebo(JS005) | Drug | Injection |
|
Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS)20 response criteria at weeks 16 and 32. |
| 16 weeks and 32 weeks |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) | Changes in ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) from baseline at weeks 16 and 32 | 16 weeks and 32 weeks |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1 | Proportion of subjects with ASDAS-CRP less than 2.1 at weeks 16 and 32. | 16 weeks and 32 weeks |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 1.1 | The proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) change of 1.1 or greater from baselinat weeks 16 and 32. | 16 weeks and 32 weeks |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 2.0 | The proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) change of 2.0 or greater from baselinat weeks 16 and 32. | 16 weeks and 32 weeks |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) < 1.3 | Proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) less than 1.3 at weeks 16 and 32 | 16 weeks and 32 weeks |
| Assessment of SpondyloArthritis International Society criteria (ASAS) partial remission | Proportion of subjects who achieved partial remission of Assessment of SpondyloArthritis International Society criteria (ASAS) at weeks 16 and 32 | 16 weeks and 32 weeks |
| Pharmacokinetic(PK) | To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005 | 40 weeks |
| Immunogenicity | The immunogenicity of JS005 was assessed by the positive incidence and titer of drug-resistant antibodies (ADA) and the incidence of neutralizing antibodies (NAb), if applicable | 40 weeks |
| Jilin Province People's Hospital | Not yet recruiting | Jilin City | Changchun | 130021 | China |
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| Zhongshan Hospital Xiamen University | Not yet recruiting | Xiamen | Fujian | 361004 | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
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| Gansu Provincial Hospital | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| Dongguan People's Hospital | Not yet recruiting | Dongguan | Guangdong | 523018 | China |
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| Sun Yat-sen Memorial Hospital | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
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| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510180 | China |
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| Zhujiang Hospital of Southren Medical University | Not yet recruiting | Guangzhou | Guangdong | 510280 | China |
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| The Third Affiliated Hospital of Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510630 | China |
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| Huizhou Central People's Hospital | Not yet recruiting | Huizhou | Guangdong | 516001 | China |
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| Jieyang People's Hospital | Recruiting | Jieyang | Guangdong | 522000 | China |
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| The First Affiliated Hospital of Shantou University Medical College | Not yet recruiting | Shantou | Guangdong | 515041 | China |
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| Shenzhen People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 518020 | China |
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| Shenzhen Second People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 518035 | China |
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| Nanyang Central Hospital | Recruiting | Nanyang | Henan | 473003 | China |
|
| Zhengzhou Central Hospital | Not yet recruiting | Zhengzhou | Henan | 450001 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Zhuzhou Central Hospital | Not yet recruiting | Zhuzhou | Hunan | 412007 | China |
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| The First Affiliated Hospital of Baotou Medical University | Not yet recruiting | Baotou | Inner Mongolia | 014010 | China |
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| The Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | 010030 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210008 | China |
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| Xuzhou Central Hospital | Not yet recruiting | Xuzhou | Jiangsu | 221006 | China |
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| First Affiliated Hospital of Gannan Medical University | Not yet recruiting | Ganzhou | Jiangxi | 341000 | China |
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| The First People's Hospital of Jiujiang City | Not yet recruiting | Jiujiang | Jiangxi | 332000 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The Second Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| Pingxiang People's Hospital | Not yet recruiting | Pingxiang | Jiangxi | 337055 | China |
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| Bethune First Hospital Of Jilin University | Not yet recruiting | Changchun | Jilin | 130021 | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| Binzhou Medical University Hospital | Not yet recruiting | Binzhou | Shandong | 256603 | China |
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| Shandong Provincial Hospital | Not yet recruiting | Jinan | Shandong | 250021 | China |
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| Zaozhuang Municipal Hospital | Not yet recruiting | Zaozhuang | Shandong | 277100 | China |
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| Shanghai Changzheng Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200003 | China |
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| Second Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030001 | China |
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| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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| Xinjiang Uygur Autonomous Region People's Hospital | Not yet recruiting | Ürümqi | Xinjiang | 830001 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
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| 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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