Project
Lilly JAHZ A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib
Completed · 2019 until 2022
Rubbert-Roth Andrea, Neumann Thomas, Bartz-Batliner Mira, Hutz Carina Liane, Peischl Riana, Sasselli Clelia
Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2019
End Date
2022
Financing
Industry
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]).
Keywords
Lupus, Baricitinib
Brief description/objective
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib
in Patients with systemic lupus erythematosus (SLE).