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A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises

Sickle Cell Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04927247
Study type Interventional
Source Pfizer
Contact
Status Terminated
Phase Phase 3
Start date December 13, 2021
Completion date November 24, 2023
View Details
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