A randomized, double-blind, placebo-controlled, parallel-group, phase 2 study evaluating the efficacy and safety of Baricitinib in patients with Systemic Lupus Erythematosus (SLE)

JAHH is a Phase 2, multicenter, randomized, double-blind, placebo controlled, outpatient, 24-week study evaluating the efficacy and safety of baricitinib 4-mg and 2-mg in patients with SLE receiving standard therapy. Approximately 300 patients will be randomized 1:1:1 to receive baricitinib 4-mg daily, baricitinib 2-mg daily, or placebo (100 patients per treatment group).

Study phase: II

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

- Are at least 18 years of age.
- Have received a clinical diagnosis of SLE at least 24 weeks prior to screening
- Have history of a positive antinuclear antibody (ANA) or a positive anti-dsDNA
- Have active arthritis and/or rash due to SLE

Primary disease category: Autoimmune Disorders

Sponsor: Eli Lilly

Protocol number: I4V-MC-JAHH

Projected enrollment dates: February 2016 to December 2016

Official study title: A randomized, double-blind, placebo-controlled, parallel-group, phase 2 study evaluating the efficacy and safety of Baricitinib in patients with Systemic Lupus Erythematosus (SLE)