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)
NCT06439082 · SPARKLE Phase 3Recruiting
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 354 (estimated)
- Start date
- 24 Oct 2024
- Primary completion
- 2 Jul 2029 (estimated)
- Study completion
- 29 Jul 2030
- Last update posted
- 15 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 2
Interventions
- Crizanlizumab Biological
- Placebo Drug
Conditions and primary outcome
- Sickle Cell Disease
Primary outcome
Annualized rate of VOCs that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm (1 year)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06439082.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06439082 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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