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- A phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (crizanlizumab), with or without Hydroxyurea/Hydroxycarbamide, in Adult Sickle Cell Patients with Vaso-Occlusive Crisis
Clinical Trial
A phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (crizanlizumab), with or without Hydroxyurea/Hydroxycarbamide, in Adult Sickle Cell Patients with Vaso-Occlusive Crisis
This is a study to findout if the drug crizanlizumab (SEG101) is safe and has beneficial effects in people who have sickle cell disease (SCD). The study drug, SEG101, is investigational, meaning it is not yet approved for use in the United States by the Food and Drug Administration (FDA) for the treatment of SCD. SEG101 is designed to attach to specific cells in the bloodstream and prevent these cells from interacting with other cells that are thought to be involved in sickle cell pain crises. Paticipants in this study will receive SEG101 (5 mg or 7.5 mg) by intravenous (IV) infusion twice during the first month of participation and then once every four weeks.
Eligibility Criteria
- To be eligible to participate, patients must: be 18-70 years of age have a confirmed diagnosis of sickle cell disease meet certain laboratory levels have experienced at least one pain crisis within the previous year that required treatment at a medical facility from a healthcare professional.
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