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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC18 160mg | Experimental | Patients received the test group RC18 160mg weekly administered subcutaneously for 52 times. |
|
| Placebo | Placebo Comparator | Patients received the test group Placebo weekly administered subcutaneously for 52 times. |
|
| 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,Tacrolimus ,ciclosporin ) |
| Measure | Description | Time Frame |
|---|---|---|
| SLE Responder Index (SRI) Response Rate | At Week 52 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 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score | Week 52 | |
| Mean Change From Baseline in Physician's global assessment(PGA) | Physician's global assessment, PGA.The measurement tool is Visual Analogue Scale/Score(VAS).The doctor assesses participant's disease activity on a VAS of 0-100 mm on the questionnaire form.The higher values represent a worse outcome.There are not combined subscales. |
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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, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Remegen,ltd. | Yantai | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41092329 | Derived | van Vollenhoven RF, Wang L, Merrill JT, Liu Y, Bao C, Li F, Hu J, Huang C, Zhao J, Huang C, Mo H, Wei W, Lu F, Li J, Zhao D, Wang W, Li L, Zuraw Q, Wang X, Wang X, Fang J, Zhang F; 18C010 Trial Investigators. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. N Engl J Med. 2025 Oct 16;393(15):1475-1485. doi: 10.1056/NEJMoa2414719. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 13, 2025 | |
| Reset | Nov 24, 2025 | |
| Release | Jun 9, 2026 |
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|
|
| 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,Tacrolimus ,ciclosporin ) |
|
|
| Week 52 |
| Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline or ≤ 7.5 mg/Day,During Weeks 44 Through 52. | Week 44 through 52 |
| Mean Change From Baseline in Serological Examination Index | week 52 |
| The flare time after randomization | 52 weeks |
| Reset | Jul 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 13, 2025 | Nov 24, 2025 | |||
| Jun 9, 2026 | Jul 6, 2026 |
| 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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