Crizanlizumab for Sickle Cell Disease
(SPARKLE Trial)
Trial Summary
The trial does not specify if you need to stop taking your current medications. However, if you are on hydroxyurea/hydroxycarbamide or an erythropoietin stimulating agent, you must have been on a stable dose for at least 3 months and plan to continue it during the study.
Crizanlizumab has been shown to reduce the frequency of painful episodes in sickle cell disease by 45.3% compared to a placebo in a clinical trial. It is approved for use in patients aged 16 and older to help prevent these painful crises.
12345Crizanlizumab, used for sickle cell disease, has been generally safe in studies, with common side effects including infusion reactions, joint pain, diarrhea, and nausea. Serious side effects were rare, and no treatment-related serious adverse events were reported.
12346Crizanlizumab is unique because it targets P-selectin, a protein that plays a key role in the inflammation and blockage of blood vessels in Sickle Cell Disease, helping to reduce pain crises. This mechanism is different from other treatments that primarily focus on managing symptoms or increasing fetal hemoglobin levels.
7891011Eligibility Criteria
This trial is for adolescents and adults aged 12 years and older with confirmed Sickle Cell Disease (SCD). They must have experienced 4 to 12 vaso-occlusive crises (VOCs) in the past year. If they're on hydroxyurea/hydroxycarbamide, it should be a stable dose for at least 3 months before the study.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Crizanlizumab 5 mg/kg or placebo, with or without hydroxyurea/hydroxycarbamide therapy, for the management of vaso-occlusive crises
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term safety and efficacy outcomes, including adverse events and immunogenicity
Participant Groups
Crizanlizumab is already approved in United States for the following indications:
- Prevention of recurrent vaso-occlusive crises in sickle cell disease patients aged 16 years and older