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The trial will evaluate pharmacodynamics,pharmacokinetics,safety,and efficacy of JMKX000189 versus placebo in participants with moderately to severely active systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMKX000189 - higher dose | Experimental | Randomized 16 patients will be received JMKX000189 at a higher dose in oral continuously from Week 0 to Week 12 in addition to SOC. |
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| JMKX000189 - lower dose | Experimental | Randomized 16 patients will be received JMKX000189 at a lower dose in oral continuously from Week 0 to Week 12 in addition to SOC. |
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| Placebo | Placebo Comparator | Randomized 16 patients will be received Placebo in oral continuously from Week 0 to Week 12 in addition to SOC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX000189 | Drug | JMKX000189 will be administered orally once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Lymphocyte Count From Baseline to Week 12 | Baseline,Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 4,8,12 and 16 in the modified SLEDAI (mSLEDAI) score | Baseline, Week 4, 8,12, and 16 | |
| Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 4,8,12 and 16 | Baseline, Week 4, 8,12, and 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanquan Yan | Contact | +86 16602106063 | yanquanquan@jemincare.com | |
| Yahui Li | Contact | +86 13311680015 | liyahui@jemincare.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Not yet recruiting | Bengbu | Anhui | 233004 | China | |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo | Drug | Placebo will be administered orally once a day |
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| Percentage of Participants Achieving No worsening in Physician Global Assessment (PGA) of Disease Activity at Week 4,8,12 and 16, No worsening defined as an increase of PGA < 0.3 Points from baseline | Baseline, Week 4, 8,12, and 16 |
| Xuanwu Hospital, Capital Medical University |
| Not yet recruiting |
| Beijing |
| Beijing Municipality |
| 100053 |
| China |
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital of Henan University of science and Technology | Not yet recruiting | Luoyang | Henan | 471003 | China |
| Xinxiang Central Hospital | Not yet recruiting | Xinxiang | Henan | 453099 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
| Pingxiang People's Hospital | Not yet recruiting | Pingxiang | Jiangxi | 337055 | China |
| China-Japan Union Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130033 | China |
| Binzhou Medical University Hospital | Not yet recruiting | Binzhou | Shandong | 256603 | China |
| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250012 | China |
| Jining First People's Hospital | Not yet recruiting | Jining | Shandong | 272002 | China |
| Huashan Hospital Affiliated to Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200127 | China |
| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | 030032 | China |
| West China Hospital Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |