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A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)

Testing crizanlizumab for sickle cell patients with frequent pain episodes.

Recruiting
12 years and older
All
Phase 3

This study looks at how safe and effective a medicine called crizanlizumab is for people with Sickle Cell Disease (SCD) who have frequent vaso-occlusive crises (VOC). SCD is a blood disorder that affects red blood cells, and VOCs are painful episodes that occur when blood vessels get blocked. The study compares crizanlizumab to a placebo, which is a substance with no active medicine. Participants can be taking another medicine called hydroxyurea/hydroxycarbamide but must have at least 4 VOCs in the year before joining. The study will include people aged 12 and older who have these conditions.

  • The study lasts about 52 weeks, during which participants will receive either crizanlizumab or placebo.
  • Participants will be randomly assigned to receive crizanlizumab or placebo, and neither they nor the doctors will know which they are getting.
  • Participants must not have had certain treatments or conditions, like a stem cell transplant or blood transfusion, recently.
Study details
    Sickle Cell Disease

NCT06439082

Novartis Pharmaceuticals

5 January 2025

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