A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus

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

2021-11-01

Completion

2022-03-09

Outcome

Met primary endpoint

Stopped: “Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.”

paper The primary endpoint in this study was met for the 4 mg baricitinib group. PMID 36848918 ↗

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.
• Morand EF, Vital EM, Petri M, van Vollenhoven R, Wallace DJ, Mosca M, Furie RA, Silk ME, Dickson CL, Meszaros G, Jia B, Crowe B, de la Torre I, Dorner T. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I). Lancet. 2023 Mar 25;401(10381):1001-1010. doi: 10.1016/S0140-6736(22)02607-1. 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

Indications