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The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE, Besides ,to provide dose basis for follow-up clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator | Placebo Comparator | Placebo SC plus standard therapy; placebo once weekly ,and total of 48 doses |
|
| RC18 80 mg plus standard therapy | Experimental | RC18 80 mg/kg SC plus standard therapy RC18 80 mg SC once weekly X 48 doses |
|
| RC18 160 mg plus standard therapy | Experimental | RC18 160 mg/kg SC plus standard therapy RC18 160 mg SC once weekly X 48 doses |
|
| RC18 240 mg plus standard therapy | Experimental | RC18 240 mg/kg SC plus standard therapy RC18 240 mg SC once weekly X 48 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo plus standard therapy | Biological | Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ) |
| Measure | Description | Time Frame |
|---|---|---|
| SLE Responder Index (SRI) Response Rate | At Week 48, the percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score and increasing no more than 0.3 points in PGA and no new BILAG A organ domain score or 1 new BILAG B organ domain scores compared with baseline at the time of assessment. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in PGA | Week 48 | |
| Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline or ≤ 7.5 mg/Day During Weeks 44 Through 48 | Week 44 through 48 | |
Inclusion Criteria:
Exclusion Criteria:
Evaluation criteria for severity :
Alanine aminotransferase(ALT)or aspartate aminotransferase (AST) ≥2 upper limit of normal (ULN);
Creatinine Clearance (Ccr)<30ml/min;
White Blood Cell Count(WBCs)<2.5x 10(9)/L;
hemoglobin<85g/L;
Platelets<50x 10(9)/L.
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| Name | Affiliation | Role |
|---|---|---|
| Fengchun Zhang | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38129117 | Derived | Wu D, Li J, Xu D, Merrill JT, van Vollenhoven RF, Liu Y, Hu J, Li Y, Li F, Huang C, Wang G, Li X, Zhao J, Zhao D, Huang C, Liu H, Wei W, Shi G, Lu F, Zuo X, Bi L, Li Z, Wang X, Zhang M, Tie N, Li J, Mo H, Fang J, Bao C, Zhang F. Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2024 Mar 12;83(4):475-487. doi: 10.1136/ard-2023-224854. |
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|
|
| RC18 80 mg plus standard therapy | Biological | Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ) |
|
|
| RC18 160 mg plus standard therapy | Biological | Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ) |
|
|
| RC18 240 mg plus standard therapy | Biological | Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ) |
|
|
| Mean Change From Baseline in Serological Examination Index(IgG、IgA、IgM) CD19+、Anti-dsDNA 、Complent C3、C4 |
| week 48 |
| 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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C035529 | RC-18 |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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