Study on Crovalimab for Preventing Painful 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, a genetic condition that affects the red blood cells, causing them to become misshapen and leading to various health complications. The study is evaluating a treatment called Crovalimab, which is being tested to see if it can help prevent painful episodes known as vaso-occlusive episodes (VOE) that occur in people with this disease. These episodes happen when the sickle-shaped cells block blood flow, causing pain and potential damage to organs.

The purpose of the study is to assess how effective and safe Crovalimab is compared to a placebo. Participants in the study will receive either Crovalimab or a placebo, which is a substance with no active medication, to compare the outcomes. Crovalimab is administered as a solution for injection or infusion, meaning it is given directly into the bloodstream through a vein or under the skin. The study will monitor participants over a period to observe any changes in the frequency and severity of their VOEs, as well as other health measures.

Throughout the study, researchers will collect information on how often participants experience VOEs, both at home and in medical facilities, and any changes in their overall health. The study will also look at other health indicators, such as changes in blood tests and the time it takes for a participant to experience their first VOE after starting the study. This information will help determine if Crovalimab is a beneficial treatment option for people with Sickle Cell Disease.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying a confirmed diagnosis of sickle cell disease and ensuring a body weight of at least 40 kg.

Vaccinations against specific infections such as N. meningitides, H. influenza type B, and S. pneumonia are required before starting the trial.

2 randomization

Participants will be randomly assigned to receive either the crovalimab or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

3 treatment administration

The treatment involves receiving crovalimab or a placebo as a solution for injection or infusion. The administration can be either intravenous (IV) or subcutaneous (SC), depending on the study protocol.

The frequency and dosage of the treatment will be determined by the study team and will continue for the duration of the trial.

4 regular monitoring

Throughout the trial, regular monitoring will be conducted to assess the efficacy and safety of the treatment. This includes tracking the annualized rate of vaso-occlusive episodes (VOEs) and other health measures.

Participants may be required to report VOEs experienced at home using a handheld device.

5 follow-up assessments

Follow-up assessments will be conducted to evaluate changes in health measures from the start of the trial to week 49. This includes changes in blood tests, urinary tests, and fatigue levels.

The study will also monitor the time to the first medical facility VOE from randomization and other secondary health outcomes.

6 completion of trial

The trial is estimated to end by August 2026. Upon completion, participants will undergo a final assessment to gather data on the long-term effects of the treatment.

Who Can Join the Study?

Body weight must be at least 40 kg (about 88 pounds).
Can be male or female with a confirmed diagnosis of HbSS (a type of sickle cell anemia) or HbSβ0 (a type of sickle cell beta zero thalassemia).
Must have had between 2 to 10 documented episodes of pain or other complications related to sickle cell disease in the past year.
If taking other treatments for sickle cell disease, the dose must have been stable for at least 3 months before joining the study, with no plans to change the dose during the study unless for safety reasons.
Must have received vaccinations against N. meningitides (types A, C, W, and Y), H. influenza type B, and S. pneumonia.
Must have adequate liver and kidney function.

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 around the body, are shaped like a sickle or crescent, instead of being round.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it usually means that only people of certain ages can join.
Patients who are not part of the specified clinical trial groups cannot participate. This means that only certain groups of people, based on specific characteristics, are allowed to join.
Patients who are not male or female cannot participate. This means that the study is open to both men and women.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population might include people who need special protection, like children or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
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
Aquranwsk Ugs	Amsterdam	The Netherlands
Hkmxqgs Hjdft Meqfao &tmiovf 1 rol Guzrsem Ezkfuf	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.03.2022
Italy	Not recruiting	08.03.2022
Spain	Not recruiting	08.03.2022
The Netherlands	Not recruiting	08.03.2022

Trial locations

Crovalimab is a medication being studied for its potential to help prevent painful episodes in people with sickle cell disease. These episodes, known as vaso-occlusive episodes, occur when blood flow is blocked by sickle-shaped red blood cells. Crovalimab is designed to work by targeting a specific part of the immune system that may contribute to these blockages. The goal of using crovalimab in this study is to see if it can reduce the frequency or severity of these episodes, making life more comfortable for people with sickle cell disease.

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 episodes of pain known as vaso-occlusive events (VOEs). Over time, the disease can cause damage to organs and tissues due to reduced blood flow and oxygen delivery. Patients may experience complications such as acute chest syndrome, which affects the lungs, and increased risk of infections. The disease progresses with varying severity, and symptoms can fluctuate over time.

Trial ID:

2022-502542-28-00

Protocol code:

BO42451

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Crovalimab for Preventing Painful Episodes in Sickle Cell Disease Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?