Clinical Trials Directory

Trials / Terminated

TerminatedNCT04927247

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

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

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
72 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGInclacumabInclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.
DRUGPlaceboPlacebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug.

Timeline

Start date
2021-12-09
Primary completion
2023-11-24
Completion
2023-11-24
First posted
2021-06-15
Last updated
2024-12-11
Results posted
2024-12-11

Locations

59 sites across 14 countries: United States, Brazil, Colombia, France, Germany, Italy, Kenya, Lebanon, Nigeria, Oman, Saudi Arabia, Turkey (Türkiye), United Kingdom, Zambia

Regulatory

Source: ClinicalTrials.gov record NCT04927247. Inclusion in this directory is not an endorsement.