SPARKLE Study: Crizanlizumab for Sickle Cell Disease
This study, called SPARKLE, is looking into how well and how safely a medicine called crizanlizumab works compared to a placebo (an inactive substance) for people with sickle cell disease. Crizanlizumab is given through an IV. The study is for adolescents and adults, aged 12 to 100, who experience frequent vaso-occlusive crises (VOCs), which are painful episodes caused by blocked blood vessels. To join, you need a confirmed diagnosis of sickle cell disease. The main goal is to see if crizanlizumab can reduce the number of VOCs that require healthcare attention over one year. The study plans to enroll 354 participants, but its current status is unclear.
- Study design
- This is a randomized, placebo-controlled, double-blind study, meaning participants are randomly assigned to receive either crizanlizumab or placebo, and neither you nor your doctors will know which you are receiving. It involves 354 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 1 year, suggesting participants will be followed for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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)
At a glance
Conditions
Where it's being run
34 sites across 22 statesWho to contact
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What this trial measures
- Annualized rate of VOCs that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm1 year
Vaso oclusive crisis (VOC) is defined as a pain crisis (acute onset of pain for which there is no other medically determined explanation other than vaso-occlusion) lasting for at least 4 hours which is treated as per local guidelines with standard of care therapy used to treat VOC. Acute chest syndrome (ACS), priapism and hepatic or splenic sequestration will be considered VOC in this study. VOCs included are those HCP-managed in a healthcare facility and HCP-managed via remote consultation. Annualized rate of VOC events = (Number of VOC events \* 365)/(number of days in the observation period). Observation period = time from date of randomization to minimum of (last dose date until treatment discontinuation + 27 days, date of initiation or discontinuation of HU/HC or L-Glutamine (or other therapies such as Voxelotor and erythropoietin therapies to treat SCD and/or to prevent/reduce VOCs), date of randomization + 365 days).