drugset / Trial / NCT03616964
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
RandomizedParallel-groupDouble-blindTreatment
Summary
The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).
Timeline
- Start
- 2018-08-02
- Primary completion
- 2021-09-24
- Completion
- 2021-10-20
Publications
- Yin J, Hou Y, Wang C, Qin C. Clinical outcomes of baricitinib in patients with systemic lupus erythematosus: Pooled analysis of SLE-BRAVE-I and SLE-BRAVE-II trials. PLoS One. 2025 Apr 30;20(4):e0320179. doi: 10.1371/journal.pone.0320179. eCollection 2025.
- Petri M, Bruce IN, Dorner T, Tanaka Y, Morand EF, Kalunian KC, Cardiel MH, Silk ME, Dickson CL, Meszaros G, Zhang L, Jia B, Zhao Y, McVeigh CJ, Mosca M. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II). Lancet. 2023 Mar 25;401(10381):1011-1019. doi: 10.1016/S0140-6736(22)02546-6. Epub 2023 Feb 24.
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baricitinib | Small molecule | 2 mg | Oral |
| Subject | Baricitinib | Small molecule | 4 mg | Oral |