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To demonstrate the efficacy of SHR-1314 at Week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h UPCR, compared to placebo. The study will also assess the safety and tolerability of SHR-1314 in the patient population over the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 | Drug | SHR-1314 s.c. + Steroids |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| percentage change of 24 hours UPCR from baseline to Week 12. | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of 24 hours UPCR from baseline to Week 24 | from baseline to Week 24 | |
| Percentage change of 24 hours UPCR from Week 12 to Week24 | from Week 12 to Week24 | |
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Inclusion Criteria:
Chinese adult pts (18-65yr), Male or Female
BMI≥18 kg/m2 and ≤ 35kg/m2
Confirmed diagnosis of LN, renal biopsy report data is within 3-months prior to the date of ICF is first signed
3.1 Biopsy-proven proliferative lupus nephritis Class III or Class IV, either with or without the presence of Class V, using the 2003 ISN/RPS criteria.
3.2 24h UPCR ≥ 1 at screening.
3.3 24h UPR ≥ 1.0 g/d,≤ 3.5 g/d.
3.4 eGFR > 45ml/min/1.73m2.
SLEDAI-2K≥8.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuxian Zhu, M.M | Contact | 0518-82342973 | yuxian.zhu@hengrui.com |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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SHR-1314 subcutaneous administration, a multicentre, randomized, double-blind, parallel, placebo-controlled study
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| Drug |
Placebo s.c. + Steroids |
|
| Percentage of participants achieving 24h UPCR <0.5 g/g at Week 12 and Week 24 |
| at Week 12 and Week 24 |
| Percentage of participants achieving renal Complete Response at Week 12 and Week 24 | at Week 12 and Week 24 |
| Percentage of pts achieving renal Partial Response at Week 12 and Week 24 | at Week 12 and Week 24 |
| Change in PGA from baseline to Week 12 and Week 24 | from baseline to Week 12 and Week 24 |
| Change in SLEDAI-2K from baseline to Week 12 and Week 24 | from baseline to Week 12 and Week 24 |
| 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 |