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This study will evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIL62(Part A and B) | Experimental |
| |
| Placebo (Part A and B) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIL62 | Drug | MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, and W55D1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B:Percentage of participants achieving SRI-4 at Week 12 | at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B:Proportion of participants achieving SRI-4 at Week 52 | at Week 52 | |
| Part A and Part B:Proportion of participants achieving SRI-4 at Week 24 | at Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 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 by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, and W55D1. |
|
| Part A and Part B:Proportion of participants achieving SRI-4 at Week76 |
| at Week 76 |
| Part A and Part B:Change From Baseline in 24-hour urine protein in participants with elevated baseline urine protein (24-hour urine protein ≥ 0.5g) at Week 24,52,76 | up to 76 weeks after randomization |
| Part A and Part B:Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52 | from Week 40 to Week 52 after randomization |
| Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 24, 52, 76 | up to 76 weeks after randomization |
| Part A and Part B:Change From Baseline in Serum Immunoglobulin Levels at Week 24 Change from baseline in the serum levels of IgG, IgA, IgM | up to 76 weeks after randomization |
| Part A and Part B:Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4) | up to 76 weeks after randomization |
| Part A and Part B:Percentage of Participants with Adverse Events | up to 76 weeks after randomization |
| Part A: Pharmacokinetic(PK) Parameters: AUC | The area under the curve (AUC) of serum concentration of the drug after the administration | up to 76 weeks after randomization |
| Part A: Pharmacokinetic(PK) Parameters:Cmax | Maximum concentration(Cmax) of the drug after administration | up to 76 weeks after randomization |
| Part A and Part B: Pharmacodynamics(PD) characteristics:summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells, CD3⁺CD4⁺ T cells, CD3⁺CD8⁺ T cells, NK cells, CD19⁺CD27⁺ B cells, and CD19⁺CD27- naïve B cells | up to 76 weeks after randomization |
| Part Aand Part B: Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62 | up to 76 weeks after randomization |