THRIVE-132: Therapy for Reduction in VOC Readmissions with Inclacumab

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The Sickle Cell 101 research team in collaboration with study investigator have reviewed this information to ensure it is patient-friendly and accurate.

About the Study

The THRIVE-132 study is determining the safety and efficacy of a single dose of inclacumab, an investigational therapy, as a possible treatment to prevent readmission to the hospital for a vaso-occlusive crises (VOCs) in individuals with sickle cell disease.

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Participation information

Countries

6 United States sites

3 Turkey sites

2 Lebanon sites

1 Italy site

1 Kenya site

1 Omanc site

Age

12 years or older

Gender

All

Genotypes

All types of SCD

Study Information

Study type

Clinical

Interventions

Inclacumab

Phase

3

Compensation

No

Am I Eligible?

Requirements

You may be eligible to participate in this study if you:
  • Have had a vaso-occlusive crisis (VOCs) that required admission to a healthcare facility and treatment with IV or IM pain medication
    • A VOC can be an acute pain episode, acute chest syndrome (ACS), hepatic sequestration, splenic sequestration, or priapism
  • Have a confirmed diagnosis of sickle cell disease
  • Are 12 years of age or older
  • Have had between 2 and 10 VOCs over the past 12 months
  • Participants taking 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 stay on a stable regimen throughout the course of the study
  • Participants taking hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to screening and expected to stay on a stable regimen throughout the course of the study

Restrictions

You can't participate in this study if you:
  • Regularly receive red blood cell transfusions
  • Receive or have received crizanlizumab (ADAKVEO®) within 90 days prior to screening
  • Weight more than 292 lbs (133kg)
  • Other protocol-defined inclusion/exclusion criteria may apply

Study point of contact

Supriya Rao
[email protected]

Study Sites

  • 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
  • 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
  • Napoli, Italy, Azienda Ospedaliera Universitaria
  • Eldoret, Kenya, International Cancer Institute (ICI)
  • Beirut, Lebanon, American University of Beirut Medical Center
  • Tripoli, Lebanon, Nini Hospital
  • Seeb, Omanc, Sultan Qaboos University Hospital
  • Adana, Turkey, Acibadem Adana Hospital
  • Ankara, Turkey, Hacettepe University Ihsan Dogramaci Children’s Hospital
  • Mersin, Turkey, Mersin University Medical Faculty
View the study on Clinicaltrials.gov Enroll in this Study
Last updated October 7, 2022