Clinical Trial
Study Details
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 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.
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.
Study Overview
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.
Contacts and 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
Uni of Illinois Hospital and HSC
Chicago, Illinois 60612
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
Thomas Jefferson University Me
Philadelphia, Pennsylvania 19107
United States
Texas Childrens Cancer and Hematology Center
Houston, Texas 77030
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
40100
Kenya
Novartis Investigative Site
Eldoret
30100
Kenya
Novartis Investigative Site
Kisumu
40100
Kenya
Novartis Investigative Site
Kisumu
40103
Kenya
Novartis Investigative Site
Siaya
40600
Kenya
Novartis Investigative Site
Kampala
Uganda
Novartis Investigative Site
Masaka
Uganda
Novartis Investigative Site
Tororo
Uganda