Actively Recruiting
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)
Led by Novartis Pharmaceuticals · Updated on 2026-05-14
315
Participants Needed
32
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 12 years and older at consent
- Confirmed diagnosis of Sickle Cell Disease by hemoglobin electrophoresis or high-performance liquid chromatography
- Experienced 4 to 12 healthcare professional-managed vaso-occlusive crises in the 12 months before screening
- If on hydroxyurea or hydroxycarbamide, must have been on stable dose for at least 3 months and plan to continue through 52 weeks
- If on erythropoietin stimulating agent, must have been receiving it for at least 6 months and plan to continue through 52 weeks
- Participants not on hydroxyurea/hydroxycarbamide or erythropoietin stimulating agents must not have received these treatments for at least 6 months prior to screening
You will not qualify if you...
- Fewer than 4 or more than 12 healthcare professional-managed vaso-occlusive crises in the 12 months before screening
- History of stem cell transplant or gene therapy
- Received blood products within 30 days prior to first dosing
- History of clinical stroke, intracranial hemorrhage, or uninvestigated neurologic findings within 12 months before screening (silent infarcts on imaging allowed)
- Participation in a chronic transfusion program or planning exchange transfusion during study (episodic transfusions allowed)
- Contraindication or hypersensitivity to study drug or related compounds
- History of severe hypersensitivity to other monoclonal antibodies posing risk for infusion reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
University Of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Ctr for Inherited Blood Disorders
Orange, California, United States, 92868
Actively Recruiting
3
Childrens National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
University of Florida
Jacksonville, Florida, United States, 32209
Actively Recruiting
5
Augusta University Georgia
Augusta, Georgia, United States, 30912
Actively Recruiting
6
WCG Sonar Clinical Research
Riverdale, Georgia, United States, 30274
Actively Recruiting
7
Norton Children s Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
8
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
9
Southern Specialty Research
Flowood, Mississippi, United States, 39232
Actively Recruiting
10
Childrens Hospital at Montefiore
The Bronx, New York, United States, 10467
Actively Recruiting
11
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
12
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
13
Spoknwrdclinicaltrials
Easton, Pennsylvania, United States, 18045
Actively Recruiting
14
U of TX Health Science Ct
Houston, Texas, United States, 77030
Actively Recruiting
15
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 41253-190
Actively Recruiting
16
Novartis Investigative Site
São Luís, Maranhão, Brazil, 65020-070
Actively Recruiting
17
Novartis Investigative Site
Campinas, São Paulo, Brazil, 13083-970
Actively Recruiting
18
Novartis Investigative Site
Ribeirão Preto, São Paulo, Brazil, 14048-900
Actively Recruiting
19
Novartis Investigative Site
Sao Jose Rio Preto, São Paulo, Brazil, 15090 000
Actively Recruiting
20
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01232-010
Actively Recruiting
21
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 08270-070
Actively Recruiting
22
Novartis Investigative Site
Medellín, Antioquia, Colombia, 050001
Actively Recruiting
23
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
24
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia, 760046
Actively Recruiting
25
Novartis Investigative Site
Montería, Colombia, 230001
Actively Recruiting
26
Novartis Investigative Site
Ahero, Kisumu County, Kenya, 40100
Actively Recruiting
27
Novartis Investigative Site
Kisumu, Kenya, 40100
Actively Recruiting
28
Novartis Investigative Site
Kisumu, Kenya, 54 40100
Actively Recruiting
29
Novartis Investigative Site
Siaya, Kenya, 40600
Actively Recruiting
30
Novartis Investigative Site
Kampala, Uganda, 101
Actively Recruiting
31
Novartis Investigative Site
Masaka, Uganda
Actively Recruiting
32
Novartis Investigative Site
Tororo, Uganda, 10102
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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