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This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study). The first part has a total of 3 dose groups, with 10 subjects enrolled in each dose group. Subjects are randomly assigned to receive MIL62 combined with standard of care or placebo combined with standard of care at a 4:1 ratio. Based on the tolerability, safety, pharmacodynamics, pharmacokinetics, and preliminary efficacy of the 3 dose groups, the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dosing frequency will be determined.
Part B is open-label, enrolling 10 subjects who will receive the recommended dose of MIL62 combined with standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIL62 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Humanized Monoclonal Antibody MIL62 Injection | Drug | Phase 1b: Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week. Phase 2: Use the dose and frequency determined in Phase 1b. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving complete renal remission (CRR) at 76 weeks | Percentage of Participants with UPCR < 0.3 and estimated glomerular filtration rate (eGFR) decline ≤ 15% from baseline | week 76 |
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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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| placebo | Drug | Phase 1b: Intravenous infusion. Dose group 1 (500mg), dose group 2 (1000mg); administered on Day 1 of Weeks 1, 3, 25, 27, 53, 55, and 77. Dose group 3 (500mg), administered on Days 1, 2, 3, 4, 25, 26, 27, 28, 53, 54, 55, 56, 77, and 78 of each respective week. Phase 2: Use the dose and frequency determined in Phase 1b. |
|
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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