Summary
This Phase 3 study will assess the safety and efficacy of a single dose of inclacumab, a P-selectin inhibitor, for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD). Participants will be randomized to receive either inclacumab or placebo.
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises
Details
The study will include approximately 280 adult and adolescent participants (≥ 12 years of age) with SCD.
Eligible participants will be administered inclacumab or placebo intravenous (IV) as a single dose.
Participants that complete the study through Day 90 will be provided the opportunity to enroll in an open-label extension (OLE) study.
Keywords
Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in Sickle Cell Disease, Re-admission, Acute, blood disorders, hemoglobin, red blood cells, RBCs, sickle-like shape, mutation in hemoglobin gene, sickle-cell trait, sickle-cell crisis, SCD, VOC, SCA, Sickle Cell Anemia, Inclacumab, inclacumab 30 mg/kg