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Compares treatment options for Sickle Cell Disease
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)
ClinicalTrials.gov ID: NCT06439082
What this study is testing
What is Crizanlizumab?
Crizanlizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sickle cell disease.
Also referred to as SEG101, Adakveo®, Ryverna®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 100
You may be able to join if
- Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \<18 years old and...
- Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not...
- Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health...
- If the participant is on HU/HC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit...
You likely can't join if
- Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote...
- History of stem cell transplant and/or gene therapy.
- Received blood products within 30 days prior to Week 1 Day 1 dosing.
- Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before...
- Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange...
- Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Orange, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Augusta, Georgia, United States
- Riverdale, Georgia, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Flowood, Mississippi, United States
- The Bronx, New York, United States
- Greenville, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Easton, Pennsylvania, United States
- Houston, Texas, United States
- Salvador, Estado de Bahia, Brazil
- São Luís, Maranhão, Brazil
- Campinas, São Paulo, Brazil
- Ribeirão Preto, São Paulo, Brazil
- Sao Jose Rio Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Orange, California, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States; Augusta, Georgia, United States; Riverdale, Georgia, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.