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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Crizanlizumab: Crizanlizumab is supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab. This is a concentrate for solution for IV infusion.
Placebo: Placebo is supplied in single use 10 mL glass vials at a concentration of 0 mg/mL. This is a concentrate for solution for IV infusion.
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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 arm — 1 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).
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| University Of Alabama | Birmingham | Alabama | Recruiting |
| Ctr for Inherited Blood Disorders | Orange | California | Recruiting |
| Childrens National Hospital | Washington D.C. | District of Columbia | Recruiting |
| University of Florida | Jacksonville | Florida | Recruiting |
| Augusta University Georgia | Augusta | Georgia | Recruiting |
| WCG Sonar Clinical Research | Riverdale | Georgia | Recruiting |
| Uni of Illinois Hospital and HSC | Chicago | Illinois | Recruiting |
| Norton Children s Hospital | Louisville | Kentucky | Recruiting |
| The Johns Hopkins University School of Medicine | Baltimore | Maryland | Recruiting |
| Southern Specialty Research | Flowood | Mississippi | Recruiting |
| Childrens Hospital at Montefiore | The Bronx | New York | Recruiting |
| East Carolina University | Greenville | North Carolina | Recruiting |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | Recruiting |
| Spoknwrdclinicaltrials | Easton | Pennsylvania | Recruiting |
| Thomas Jefferson University Me | Philadelphia | Pennsylvania | Recruiting |
| Texas Childrens Cancer and Hematology Center | Houston | Texas | Recruiting |
| U of TX Health Science Ct | Houston | Texas | Recruiting |
| Novartis Investigative Site | Salvador | Estado de Bahia | Recruiting |
| Novartis Investigative Site | São Luís | Maranhão | Recruiting |
| Novartis Investigative Site | Campinas | São Paulo | Recruiting |
| Novartis Investigative Site | Ribeirão Preto | São Paulo | Recruiting |
| Novartis Investigative Site | Sao Jose Rio Preto | São Paulo | Recruiting |
| Novartis Investigative Site | São Paulo | São Paulo | Recruiting |
| Novartis Investigative Site | São Paulo | São Paulo | Recruiting |
| Novartis Investigative Site | Medellín | Antioquia | Recruiting |
| Novartis Investigative Site | Cali | Valle del Cauca Department | Recruiting |
| Novartis Investigative Site | Cali | Valle del Cauca Department | Recruiting |
| Novartis Investigative Site | Montería | Colombia | Recruiting |
| Novartis Investigative Site | Ahero | Kisumu County | Recruiting |
| Novartis Investigative Site | Eldoret | Kenya | Recruiting |
| Novartis Investigative Site | Kisumu | Kenya | Recruiting |
| Novartis Investigative Site | Kisumu | Kenya | Recruiting |
| Novartis Investigative Site | Siaya | Kenya | Recruiting |
| Novartis Investigative Site | Kampala | Uganda | Recruiting |
| Novartis Investigative Site | Masaka | Uganda | Recruiting |
| Novartis Investigative Site | Tororo | Uganda | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06439082 on ClinicalTrials.gov ↗ ← All trials in the USA