Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439082
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-27
Brief Title:
A Study to Investigate the Efficacy and Safety of Crizanlizumab 5 mgkg Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises SPARKLE
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Multicenter Randomized Placebo Controlled Double-blind Study to Assess Efficacy and Safety of Crizanlizumab 5 mgkg Versus Placebo With or Without HydroxyureaHydroxycarbamide Therapy in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03720626
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
SPARKLE
Brief Summary:
A phase III multi-center randomized placebo-controlled double-blind study to assess efficacy and safety of crizanlizumab 5 mgkg versus placebo with or without hydroxyureahydroxycarbamide 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 mgkg versus placebo with or without hydroxyurea hydroxycarbamide therapy HUHC 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 21 ratio to the crizanlizumab 5 mgkg or placebo treatment arm Central randomization will be stratified by concomitant HUHC usage yesno and region South America North America and sub-Saharan Africa at baseline
Participants will be randomized in a 21 ratio to the crizanlizumab 5 mgkg or placebo treatment arm Central randomization will be stratified by concomitant HUHC usage yesno and region South America North America and sub-Saharan Africa at baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None