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

About the study

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.

Study point of contact

Carolyn Hoppe, MD
(510) 289-9097
[email protected]
Stacy Tsukayama
[email protected]

Locations

10 United States sites

6 Nigeria sites

3 Turkey sites

2 Italy sites

2 Kenya sites

2 Lebanon sites

1 Brazil site

1 Germany site

1 Oman site

Age

> 12 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

participation requirements

Participant has an index VOC. The index VOC is any VOC that required admission to a healthcare facility and treatment with parenteral pain medication. An admission for the index VOC includes:

A hospital admission, or
An admission to an emergency room, observation unit, or infusion center for ≥ 12 hours, or
2 visits to an emergency room, observation unit, or infusion center over a 72-hour period

for an acute episode of pain with no other cause other than a vaso- occlusive event that includes the following:

Uncomplicated VOC,
Acute chest syndrome (ACS),
Acute hepatic sequestration,
Acute splenic sequestration, or
Priapism.
Participant has a confirmed diagnosis of SCD (any genotype). Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing at Baseline.
Participant is male or female, ≥ 12 years of age at the time of informed consent.

Participant has experienced between 2 and 10 VOCs within the 12 months prior to Screening as determined by documented medical history. The index VOC is not to be considered as one of the 2 to 10 events. A prior VOC is defined as an acute episode of pain that:

Has no medically determined cause other than a vaso-occlusive event, and
Results in a visit to a healthcare facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and
Requires parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to Screening and expected to continue with the stabilized regimen throughout the course of the study.
Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to Screening and expected to continue with the stabilized regimen throughout the course of the study.

participation restrictions

Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to Screening.
Participant weighs > 133 kg (292 lbs.).

Other protocol-defined Inclusion/Exclusion may apply.

Locations

  • Mobile, Alabama, United States, University of South Alabama Children's and Women's Hospital
  • Little Rock, Arkansas, United States, Arkansas Children's Hospital
  • Tampa, Florida, United States, Saint Joseph's Hospital
  • Chicago, Illinois, United States, University of Illinois at Chicago
  • Ann Arbor, Michigan, United States, University of Michigan
  • Las Vegas, Nevada, United States, Cure 4 the Kids Foundation
  • Bronx, New York, United States, Jacobi Medical Center
  • Buffalo, New York, United States, Erie County Medical Center
  • Durham, North Carolina, United States, Duke University Medical Center
  • Memphis, Tennessee, United States, St Jude Children's Research Hospital
  • Porto Alegre, Brazil, Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
  • Regensburg, Germany, Universitätsklinikum Regensburg
  • Genova, Italy, E O Ospedali Galliera
  • Napoli, Italy, Azienda Ospedaliera Universitaria
  • Eldoret, Kenya, International Cancer Institute (ICI)
  • Nairobi, Kenya, Strathmore University
  • Beirut, Lebanon, American University of Beirut Medical Center
  • Tripoli, Lebanon, Nini Hospital
  • Abuja, Nigeria, National Hospital Abuja
  • Abuja, Nigeria, University of Abuja Teaching Hospital
  • Adana, Nigeria, Baskent University Medical Faculty Adana Dr. Turgut Noyan Practice and Research Center
  • Enugu, Nigeria, University of Nigeria
  • Lagos, Nigeria, Aminu Kano Teaching Hospital
  • Suru Lere, Nigeria, Lagos University Teaching Hospital Haematology
  • Seeb, Oman, Sultan Qaboos University Hospital
  • Adana, Turkey, Acibadem Adana Hospital
  • Ankara, Turkey, Hacettepe University Ihsan Dogramaci Children's Hospital
  • Mersin, Turkey, Mersin University Medical Faculty
Last updated 2022-08-23