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NCT06439082 · ClinicalTrials.gov record · last posted 2026-08-19

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)

Study acronym: SPARKLE
StatusRecruiting
PhasePhase 3
Started2024-10-24
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-07-25
minor
Enrollment increased: 315 → 354 participants
2026-07-25
notable
Primary completion pushed: 2029-03-23 → 2029-07-02
2026-07-25
minor
Completion pushed: 2030-04-19 → 2030-07-29
Trial Details
NCT Number NCT06439082
Lead Sponsor Novartis Pharmaceuticals
Conditions Sickle Cell Disease
Enrollment 354 participants
Start Date 2024-10-24
Primary Completion 2029-07-02 (estimated)
Study Completion 2030-07-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-19