Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients
Status:
Recruiting
Trial end date:
2024-11-20
Target enrollment:
Participant gender:
Summary
The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate
dosing and to evaluate the safety in pediatric participants ages 6 months to <18 years with a
history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and
safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The
approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult
population. The study is designed as a Phase II, multicenter, open-label study.