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The study is a Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with lupus nephritis (LN). It adopts a randomized, double-blind, placebo-controlled, multicenter trial design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2173 Injection Group | Experimental |
| |
| SHR-2173 Injection Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2173 Injection | Drug | SHR-2173 injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline. | At Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects achieving complete renal response (CRR). | At Week 24 and Week 52. | |
| The proportion of subjects achieving partial renal response (PRR). | At Week 24 and Week 52. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su Zhang | Contact | +86-0518-82342973 | su.zhang.sz3@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of the Eastern Theater Command of the People's Liberation Army of China | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| SHR-2173 Injection Blank Preparation |
| Drug |
SHR-2173 injection blank preparation. |
|
| The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline. |
| At Week 24 and Week 52. |
| The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline. | At Week 24 and Week 52. |
| The proportion of subjects whose 24-hour UPCR was less than 0.5 g/g. | At Week 24 and Week 52. |
| The proportion of subjects whose 24-hour UPCR was less than 0.7 g/g. | At Week 24 and Week 52. |
| The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 5 mg/day. | At Week 24 and Week 52. |
| The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 7.5 mg/day. | At Week 24 and Week 52. |
| The changes in the Chronic Disease Treatment Function Assessment - Fatigue Scale (FACIT) score relative to the baseline. | At Week 24 and Week 52. |
| Adverse events (AEs). | Up to 52 weeks. |