Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients
Phase 3
Active, not recruiting
NCT03814746
| Condition | Sickle Cell Disease |
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| Phase | Phase 3 |
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| Sponsor | Novartis Pharmaceuticals |
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| Status | Active, not recruiting |
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| Enrollment | 255 participants |
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| Interventions | Crizanlizumab (SEG101) |
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| Start date | Jul 26, 2019 |
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| Completion date | Aug 31, 2022 |
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| Results posted | Jan 8, 2024 |
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Summary
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.
Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to a Healthcare Visit
1 year · number of events per year
| Crizanlizumab (SEG101) at 5.0 mg/kg | 2.5 ± 2.98 number of events per year |
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| Crizanlizumab (SEG101) at 7.5 mg/kg | 1.9 ± 2.30 number of events per year |
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| Placebo | 2.1 ± 2.81 number of events per year |
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| p-value | > 0.999 |
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| Rate ratio | 1.08 (95% CI 0.76–1.55) |
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Open in BENITIONS
View on ClinicalTrials.gov
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