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A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Sickle Cell Disease Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Clinical Trial Summary

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

Clinical Trial Description

Eligible participants will be administered inclacumab or placebo intravenous (IV) every 12 weeks. The total duration of treatment for each participant will be 48 weeks. Participants that complete the study through Week 48 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 NCT04935879
Study type Interventional
Source Pfizer
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 26, 2021
Completion date August 15, 2024
View Details
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