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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active non-radiographic axial spondyloarthritis(nr-axSpA). Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese nr-axSpA patients in terms of ASAS 40 response rate at Week 16 as well as safety profile will be provided by the study .
This is a randomized, double-blind, placebo-controlled study. Approximately 120 patients who meet the eligibility criteria will be randomized to one of three treatment cohorts (JS005 150 mg, 300 mg, 450mg in a ratio of 1:1:1),then using secondary randomization method, 40 patients in each group will be randomized in a 3: 1 ratio to receive investigational product or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS005 150 mg | Experimental | 30 patients will be enrolled in this arm. |
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| Placebo 150 mg | Placebo Comparator | 10 patients will be enrolled in this arm. |
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| JS005 300 mg | Experimental | 30 patients will be enrolled in this arm. |
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| Placebo 300 mg | Placebo Comparator | 10 patients will be enrolled in this arm. |
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| JS005 450 mg | Experimental | 30 patients will be enrolled in this arm. |
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| Placebo 450 | Placebo Comparator | 10 patients will be enrolled in this arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS005 | Biological | 30 subjectes in JS005 150mg chort, JS005 300mg chort, and JS005 450mg chort receive JS005 150mg, JS005 300mg and JS005 450mg subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12). |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of nr-axSpA patients meeting the Assessment of Spondylo Arthritis international Society (ASAS) 40 response criteria | at the end of treatment Week 16 . | From week 0 to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| ASAS20 response criteria | The proportion of patients meeting the ASAS20 response criteria at the end of treatment Week 16 | From week 0 to week 16 |
| ASAS 5/6 response criteria | The proportion of patients meeting the ASAS 5/6 response criteria at the end of treatment Week 16; |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic endpoint | • Population pharmacokinetic analysis of plasma concentrations will be performed to explore the exposure of JS005 in patients and the influencing factors of exposure | From Baseline to week 24,Total 24 weeks |
| Pharmacodynamic endpoint |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengbo Jia, Bachelor | Contact | 861085172616/18547265054 | chengbo_jia@junshipharma.com | |
| Jiangnian Liu, Bachelor | Contact | 18733176288 | jiangnian_liu@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | 230001 | China |
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Priticipant,Care provider and investigators are masked in this study
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| Placebo | Biological | 10 subjects in JS005 150mg chort, JS005 300mg chort, and JS005 450mgchort receive the placebo subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12). |
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| From week 0 to week 16 |
| High-sensitivity C-reactive protein (hsCRP) | The change from baseline in high-sensitivity C-reactive protein (hsCRP) at the end of treatment Week 16 | From week 0 to week 16 |
| The inflammation score of the sacroiliac joint | The change from baseline in the inflammation score of the sacroiliac joint by MRI at the end of treatment Week 16 | From week 0 to week 16 |
| Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) | The change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at the end of treatment Week 16; | From week 0 to week 16 |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | The change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the end of treatment Week 16 | From week 0 to week 16 |
| Bath Ankylosing Spondylitis Functional Index (BASFI) | The change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at the end of treatment Week 16 | From week 0 to week 16 |
| Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) | The change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at the end of treatment Week 16 | From week 0 to week 16 |
| Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) | The change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at the end of treatment Week 16 | From week 0 to week 16 |
| The patient's global assessment of disease activity | Numeric Rating Scale (NRS, ranging from 0 not active to 10 very active) will be used to evaluate the patient's global assessment of disease activity. Patient will be asked by one question: How active was your spondylitis on average during the last week? | From week 0 to week 16 |
| The patient's assessment of inflammatory back pain intensity | NRS(ranging from 0 no pain to 10 most severe pain) will be used to assess the patient's inflammatory back pain intensity. The assessment is based on two questions: "Based on your assessment, please indicate How much pain of your spine due to AS do you have ?" and "Based on your assessment, please specify How much pain of your spine due to AS do you have at night?" When responding, the subject is to consider the average amount of pain in the last week. | From week 0 to week 16 |
| ASAS partial remission criteria | The proportion of patients meeting ASAS partial remission criteria at the end of treatment Week 16 | From week 0 to week 16 |
• Concentrations and the changes of free and/or total IL-17 in serum before and after administration.
| From Baseline to week 24,Total 24 weeks |
| Immunogenicity endpoint | • Anti-drug antibody (ADA), for the ADA positive samples, it is necessary to test the titer and determine whether it is a neutralizing antibody (Nab). | From Baseline to week 24,Total 24 weeks |
| Safety evaluation | Safety evaluation will be documented as numbers of adverse event(AE). | From V1 to V12, Total 36 Weeks |
| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 410011 | China |
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| Sun Yat-sen Memorial Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
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| Nanfang Hospital of Nanfang Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| Shantou University Medical Collge No.1 Affiliated Hospital | Not yet recruiting | Shantou | Guangdong | 515041 | China |
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| Shenzhen People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 518001 | China |
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| Pking University Shenzhen Hospital | Not yet recruiting | Shenzhen | Guangdong | 518036 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 361001 | China |
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| Tongji Hospital,Tongji Medical College of HUST | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| The Third Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 361001 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410013 | China |
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| The Affilated Hospital of Inner Mongdlia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | 100000 | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130021 | China |
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| The Second Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | 116023 | China |
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| The First Affiliated Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| Shengjing Hospital of China medical University | Not yet recruiting | Shenyang | Liaoning | 110004 | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 030001 | China |
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| Shanghai Changzheng Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200003 | China |
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| First Affiliated Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 650032 | China |
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| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | 600041 | China |
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| North Sichuan Medical College Affiliated Hospital | Not yet recruiting | Nanchong | Sichuan | 637000 | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300041 | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Not yet recruiting | Ürümqi | Xinjiang | 8300001 | China |
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| First Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 250063 | China |
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| The Second Affiliated Hospital of Zhejiang University,School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 450052 | China |
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| ID | Term |
|---|---|
| D000089202 | Non-Radiographic Axial Spondyloarthritis |
| 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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