Projekt
Lilly JAHZ A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib
Abgeschlossen · 2019 bis 2022
Rubbert-Roth Andrea, Neumann Thomas, Bartz-Batliner Mira, Hutz Carina Liane, Peischl Riana, Sasselli Clelia
Art
Klinische Forschung
Reichweite
Multizentrisch, KSSG als teilnehmendes Zentrum
Bereiche
Status
Abgeschlossen
Start
2019
Ende
2022
Finanzierungsart
Industrie
Studiendesign
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]).
Schlagwörter (Tags)
Lupus, Baricitinib
Kurzbeschreibung/Zielsetzung
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib
in Patients with systemic lupus erythematosus (SLE).