Available in Colombia, United States
Study CSEG101A2303 (SPARKLE) is a Phase III, multicenter, randomized, double-blind study
to assess efficacy and safety of crizanlizumab 5 mg/kg versus placebo, with or without
hydroxyurea/ hydroxycarbamide therapy (HU/HC), in Sickle Cell Disease patients aged 12
years and older with frequent vaso-occlusive crises (4-12 events in 12 months prior to
the screening visit).
Participants will be randomized in a 2:1 ratio to the crizanlizumab 5 mg/kg or placebo
treatment arm. Central randomization will be stratified by concomitant HU/HC usage
(yes/no) and region (South America, North America, and sub-Saharan Africa) at baseline.
315Patients around the world