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Study on the Safety and Effects of Crovalimab for Treating Vaso-Occlusive Episodes in Sickle Cell Disease Patients

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What is this study about?

This clinical trial is focused on studying Sickle Cell Disease (SCD), a genetic condition that affects the red blood cells, causing them to become misshapen and leading to various health complications. The study is investigating a treatment called Crovalimab, which is administered as a solution for injection or infusion. The purpose of the study is to evaluate the safety of Crovalimab compared to a placebo in managing acute uncomplicated vaso-occlusive episodes, which are painful events that occur when blood flow is blocked in small vessels.

Participants in the study will receive either Crovalimab or a placebo. The study will monitor the safety of the treatment by observing any adverse events, changes in vital signs, and any reactions related to the infusion. Additionally, the study will measure the levels of Crovalimab in the blood over time and assess how the drug interacts with the body, including its effects on specific biological markers. The study aims to understand how quickly patients experience improvement from their vaso-occlusive episodes and to check for any antibodies that might develop against the drug.

The trial is designed to gather information over a period of time, with the estimated completion date set for October 2025. Participants will be closely monitored throughout the study to ensure their safety and to collect data on the effectiveness of Crovalimab in treating Sickle Cell Disease. This research is important for developing new treatments that can help manage the symptoms and complications associated with this condition.

1 joining the study

Upon joining the study, you will be required to confirm your eligibility. This includes having a body weight of at least 40 kg and a confirmed diagnosis of sickle cell disease, specifically HbSS or HbSβ0 genotypes.

You must have received vaccinations against Neisseria meningitidis, H. influenzae type B, and S. pneumoniae. Additionally, you should have adequate liver and kidney function and be on a stable dose of any sickle cell therapies for at least 28 days.

2 hospital admission

You will be admitted to a hospital or acute medical facility due to an acute uncomplicated vaso-occlusive episode (VOE), which requires treatment with opioid pain relievers administered through a vein or injection.

3 treatment administration

You will be randomly assigned to receive either the study medication, crovalimab, or a placebo. The medication will be given as a solution for injection or infusion, either intravenously (IV) or subcutaneously (SC).

The dosage, frequency, and duration of administration will be determined by the study protocol and communicated to you by the medical team.

4 monitoring and assessments

Throughout the study, your health will be closely monitored. This includes checking for any side effects, changes in vital signs, and results from laboratory tests.

You will also be assessed for any reactions related to the infusion and any signs of hypersensitivity.

5 follow-up evaluations

Regular follow-up evaluations will be conducted to measure the concentration of crovalimab in your blood over time and to understand how your body responds to the medication.

The study will also evaluate the time it takes for your acute VOE to improve and check for the presence of any antibodies against the medication.

Who Can Join the Study?

  • Body weight must be 40 kg or more.
  • Must have a confirmed diagnosis of HbSS (a type of sickle cell anemia) or HbSβ0 (a type of sickle cell beta zero thalassemia).
  • Must have received vaccinations against Neisseria Meningitidis (a type of bacteria), H. influenzae type B, and S. pneumoniae.
  • Must have a diagnosis of an acute uncomplicated VOE (a type of pain crisis in sickle cell disease) that requires hospital admission and treatment with parenteral opioid analgesics (pain relief medication given by injection).
  • Must have adequate liver and kidney function.
  • If receiving sickle cell therapies, the dose must be stable for 28 days or more.

Who Cannot Join the Study?

  • Patients who do not have Sickle Cell Disease cannot participate. Sickle Cell Disease is a condition where red blood cells, which carry oxygen, are shaped like a sickle or crescent, causing blockages in blood flow.
  • Patients who are not within the specified age range cannot participate. The age range includes children and adults.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific characteristics in participants.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Montpellier Montpellier France
Virgen del Rocío University Hospital Sevilla Spain
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Acyxzpdzr Uio Amsterdam The Netherlands
Hfxlcen Htxrk Mlmmlu &tvcjpy 1 ryy Gpexttd Edjmsp Creteil France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
12.12.2022
Italy Italy
Not recruiting
12.12.2022
Spain Spain
Not recruiting
12.12.2022
The Netherlands The Netherlands
Not recruiting
12.12.2022

Trial locations

Investigated drugs:

Crovalimab is a medication being studied for its potential to help manage acute uncomplicated vaso-occlusive episodes in patients with sickle cell disease. These episodes are painful events that occur when blood flow is blocked by sickle-shaped red blood cells. Crovalimab works by targeting a specific part of the immune system that may play a role in these episodes. The goal of using crovalimab in this trial is to see if it can safely reduce the frequency or severity of these painful episodes, making life easier for people with sickle cell disease.

Investigated diseases:

Sickle Cell Disease – Sickle Cell Disease is a genetic blood disorder characterized by the production of abnormal hemoglobin, known as hemoglobin S. This causes red blood cells to become rigid, sticky, and shaped like sickles or crescent moons. These misshapen cells can block blood flow, leading to pain episodes called vaso-occlusive crises. Over time, the disease can cause damage to organs and tissues due to reduced blood flow and oxygen delivery. The disease often results in anemia, as the sickle cells break down prematurely. It can also lead to complications such as infections and delayed growth in children.

Trial ID:
2022-502546-26-00
Protocol code:
BO42452
Trial Phase:
Human Pharmacology (Phase I) – Other

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