drugset / Trial / NCT02885610
Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2015-12
- Primary completion
- 2019-06-11
- Completion
- 2019-07-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telitacicept | Protein / enzyme biologic | 80 mg | Subcutaneous |
| Subject | Telitacicept | Protein / enzyme biologic | 160 mg | Subcutaneous |
| Subject | Telitacicept | Protein / enzyme biologic | 240 mg | Subcutaneous |
| Comparator | Azathioprine | Small molecule | — | — |
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Cyclosporine | Peptide | — | — |
| Comparator | Leflunomide | Small molecule | — | — |
| Comparator | Methotrexate | Small molecule | — | — |
| Comparator | Mycophenolate Sodium | Unknown | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |