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Lilly JAHZ A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib

Andrea Rubbert Roth, Thomas Neumann, Silvia Forrer, Mira Bartz Batliner & Carina Hutz

abstract A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib
in Patients with systemic lupus erythematosus (SLE).
   
type of project clinical studies
status ongoing - recruiting phase
start of project 2019
end of project 2021
study design Study I4V-MC-JAHZ (JAHZ) is a Phase 3, multicenter, randomized, double-blind,
parallel-group, placebo-controlled, outpatient, 52-week study evaluating the efficacy and safety
of baricitinib 4-mg and 2-mg in patients with SLE receiving standard therapy.
Approximately 750 patients will be randomized at a 1:1:1 ratio to receive baricitinib 4-mg daily,
baricitinib 2-mg daily, or placebo (250 patients per treatment group). Patients will be stratified
at randomization according to disease activity (total SLEDAI-2K at screening <10; ≥10),
corticosteroid dose at baseline (<10 mg/day; ≥10 mg/day prednisone or equivalent), and region
(defined in the statistical analysis plan [SAP]).
responsible person Andrea Rubbert-Roth