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NCT06439082 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Sickle Cell Disease, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 315
- Enrollment target
- 20
- Study locations
NCT06439082: Recruiting Phase 3 study of Sickle Cell Disease, sponsored by Novartis Pharmaceuticals.
NCT06439082 is a Phase 3 study of Sickle Cell Disease that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 315 participants, roughly in line with the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06439082, a Phase 3 study of Sickle Cell Disease, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 315 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Vaso oclusive crisis (VOC) is defined as a pain crisis (acute onset of pain for which there is no other medically determined explanation other than vaso-occlusion) lasting for at least 4 hours which is treated as per local guidelines with standard of care therapy used to treat VOC. Acute chest syndrome (ACS), priapism and hepatic or splenic sequestration will be considered VOC in this study. VOCs included are those HCP-managed in a healthcare facility and HCP-managed via remote consultation. A
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Crizanlizumab
Study Locations (20)
São Paulo
- Novartis Investigative Site - Campinas
- Novartis Investigative Site - Ribeirão Preto
- Novartis Investigative Site - Sao Jose Rio Preto
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
Georgia
- Augusta University Georgia - Augusta
- WCG Sonar Clinical Research - Riverdale
North Carolina
- East Carolina University - Greenville
- Wake Forest University Baptist Medical Center - Winston-Salem
Alabama
- University Of Alabama - Birmingham
District of Columbia
- Childrens National Hospital - Washington D.C.
Florida
- University of Florida - Jacksonville
Kentucky
- Norton Children s Hospital - Louisville
Maryland
- The Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2024-10-24 |
| Est. Completion | 2030-04-19 |
| Phase | Phase 3 |
What NCT06439082 shows while recruiting
NCT06439082 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target.
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06439082 names 20 study sites across 14 states, led by São Paulo, Georgia, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06439082 about?
NCT06439082 is a clinical study titled "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)". 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.
What is the current status of trial NCT06439082?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2024-10-24. Estimated completion is 2030-04-19.
What conditions does trial NCT06439082 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT06439082?
The interventions under investigation include: Placebo (DRUG), Crizanlizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06439082?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06439082 being conducted?
This trial has 20 study locations across Alabama, District of Columbia, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06439082's enrollment target sits among peer trials
315 18th of 213 higher than 196 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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