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)
Start Date
10/24/2024
Completion Date
7/29/2030
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.
Detailed Description
Study CSEG101A2303 (SPARKLE) is a Phase III, multicenter, randomized, double-blind study to assess efficacy and safety of crizanlizumab 5 mg/kg versus placebo, with or without hydroxyurea/ hydroxycarbamide therapy (HU/HC), in Sickle Cell Disease patients aged 12 years and older with frequent vaso-occlusive crises (4-12 events in 12 months prior to the screening visit). Participants will be randomized in a 2:1 ratio to the crizanlizumab 5 mg/kg or placebo treatment arm. Central randomization will be stratified by concomitant HU/HC usage (yes/no) and region (South America, North America, and sub-Saharan Africa) at baseline.
Eligibility Criteria
Age Range: 12 years to 100 years
Interventions
Crizanlizumab
Placebo
Conditions
Locations
University Of Alabama
Birmingham, Alabama 35233
United States
Ctr for Inherited Blood Disorders
Orange, California 92868
United States
Childrens National Hospital
Washington D.C., District of Columbia 20010
United States
University of Florida
Jacksonville, Florida 32209
United States
Augusta University Georgia
Augusta, Georgia 30912
United States
WCG Sonar Clinical Research
Riverdale, Georgia 30274
United States
Norton Children s Hospital
Louisville, Kentucky 40202
United States
The Johns Hopkins University School of Medicine
Baltimore, Maryland 21205
United States
Southern Specialty Research
Flowood, Mississippi 39232
United States
Childrens Hospital at Montefiore
The Bronx, New York 10467
United States
East Carolina University
Greenville, North Carolina 27834
United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157
United States
Spoknwrdclinicaltrials
Easton, Pennsylvania 18045
United States
U of TX Health Science Ct
Houston, Texas 77030
United States
Novartis Investigative Site
Salvador, Estado de Bahia 41253-190
Brazil
Novartis Investigative Site
São Luís, Maranhão 65020-070
Brazil
Novartis Investigative Site
Campinas, São Paulo 13083-970
Brazil
Novartis Investigative Site
Ribeirão Preto, São Paulo 14048-900
Brazil
Novartis Investigative Site
Sao Jose Rio Preto, São Paulo 15090 000
Brazil
Novartis Investigative Site
São Paulo, São Paulo 01232-010
Brazil
Novartis Investigative Site
São Paulo, São Paulo 08270-070
Brazil
Novartis Investigative Site
Medellín, Antioquia 050001
Colombia
Novartis Investigative Site
Cali, Valle del Cauca Department 760032
Colombia
Novartis Investigative Site
Cali, Valle del Cauca Department 760046
Colombia
Novartis Investigative Site
Montería, 230001
Colombia
Novartis Investigative Site
Ahero, Kisumu County 40100
Kenya
Novartis Investigative Site
Kisumu, 40100
Kenya
Novartis Investigative Site
Kisumu, 54 40100
Kenya
Novartis Investigative Site
Siaya, 40600
Kenya
Novartis Investigative Site
Kampala, 101
Uganda
Novartis Investigative Site
Masaka,
Uganda
Novartis Investigative Site
Tororo, 10102
Uganda