THRIVE-132: Therapy for Reduction in VOC Readmissions with Inclacumab
What is this?
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.
This study is currently recruiting study participants in the United States, Italy, Kenya, Lebanon, Oman and Turkey (specific hospitals in each country can be found in the “locations” section below). If you live in other locations not listed above, you may also be eligible to participate in this study as there are other locations that the study sponsor is actively working on to include. Please contact [email protected] to learn more about the other study sites not listed below.
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
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