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
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs 4 mg Baricitinib; p = 0.711; Odds Ratio (OR) 1.07 (95% CI 0.75 to 1.53); NCT03616964 ↗
paper There was no difference in the primary efficacy outcome of the proportion of SRI-4 responders at week 52 PMID 40305472 ↗
release “The SLE-BRAVE-II study, which also studied adults with active lupus, did not meet the primary endpoint of SRI-4 response.” incyte.com ↗
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 |