Lilly JAHZ A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib
| 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 | completed |
| start of project | 2019 |
| end of project | 2022 |
| 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 |