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To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | CM313 |
|
| Group B | Experimental | CM313 |
|
| Group C | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM313 injection | Biological | CM313 600mg(4ml)/vial. Subcutaneous injection 600mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) | SRI-4 response is defined as:
| Up to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | qianjia@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 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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| CM313 injection | Biological | CM313 600mg(4ml)/vial. Subcutaneous injection 1200mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses. |
|
| Placebo | Drug | Placebo 4 mL/vial. Subcutaneous injection 4 or 8 mL. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses. |
|