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)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Sickle Cell Disease
In brief
A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.
Key facts
- Study ID
- NCT06439082
- Run by
- Novartis Pharmaceuticals
- People needed
- 354
- Starts
- 2024-10-24
- Expected to finish
- 2030-07-29
- Last updated by the study team
- 2026-07-24
Who can join
Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University Of Alabama — Birmingham, Alabama, United States (enrolling)
- Ctr for Inherited Blood Disorders — Orange, California, United States (enrolling)
- Childrens National Hospital — Washington D.C., District of Columbia, United States (enrolling)
- University of Florida — Jacksonville, Florida, United States (enrolling)
- Augusta University Georgia — Augusta, Georgia, United States (enrolling)
- WCG Sonar Clinical Research — Riverdale, Georgia, United States (enrolling)
- Norton Children s Hospital — Louisville, Kentucky, United States (enrolling)
- The Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
- Southern Specialty Research — Flowood, Mississippi, United States (enrolling)
- Childrens Hospital at Montefiore — The Bronx, New York, United States (enrolling)
- East Carolina University — Greenville, North Carolina, United States (enrolling)
- Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States (enrolling)
- Spoknwrdclinicaltrials — Easton, Pennsylvania, United States (enrolling)
- U of TX Health Science Ct — Houston, Texas, United States (enrolling)
- Novartis Investigative Site — Salvador, Estado de Bahia, Brazil (enrolling)
- Novartis Investigative Site — São Luís, Maranhão, Brazil (enrolling)
- Novartis Investigative Site — Campinas, São Paulo, Brazil (enrolling)
- Novartis Investigative Site — Ribeirão Preto, São Paulo, Brazil (enrolling)
- Novartis Investigative Site — Sao Jose Rio Preto, São Paulo, Brazil (enrolling)
- Novartis Investigative Site — São Paulo, São Paulo, Brazil (enrolling)
- Novartis Investigative Site — São Paulo, São Paulo, Brazil (enrolling)
- Novartis Investigative Site — Medellín, Antioquia, Colombia (enrolling)
- Novartis Investigative Site — Cali, Valle del Cauca Department, Colombia (enrolling)
- Novartis Investigative Site — Cali, Valle del Cauca Department, Colombia (enrolling)
- Novartis Investigative Site — Montería, Colombia (enrolling)
Full record on ClinicalTrials.gov
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