A RANDOMIZED DOUBLE-BLIND PHASE IIA STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB AS ADJUNCT TREATMENT IN PREVENTION OF VASO-OCCLUSIVE EPISODES (VOE) IN SICKLE CELL DISEASE (SCD)
This research study is looking at a new medicine called crovalimab. It's for adults aged 18 and over who have sickle cell disease. Researchers want to find out how well crovalimab works to prevent painful crises, known as vaso-occlusive episodes (VOEs), and if it's safe. They are also studying how the body uses and gets rid of the medicine. Participants will take crovalimab in addition to their current treatments. The main goal is to see if taking crovalimab lowers the number of hospital visits for these painful events. They will also look at how many VOEs happen at home, hospital stays, and how the medicine affects blood tests and overall well-being.
At a glance
What is this study about?
This study is about an important condition called sickle cell disease, which affects many people in the UK. Sickle cell disease causes red blood cells to become stiff and C-shaped, like a sickle. These sickle cells can get stuck in small blood vessels, blocking blood flow and causing sudden, severe pain called vaso-occlusive episodes (VOEs), often referred to as sickle cell crises. These crises can be very painful and sometimes lead to hospital stays or other health problems.
Researchers are investigating a new medicine called crovalimab. The main purpose of this study is to see if crovalimab, when added to a patient's existing treatment, can help reduce the number of painful VOEs they experience. They also want to understand if the medicine is safe to use and how it works within the body.
This is a 'Phase II' study, which means it's an earlier stage of research where scientists are still learning about the medicine's effectiveness and looking closely at its side effects. The results from this study will help decide if crovalimab is a good candidate for further, larger studies, and eventually, if it could become a new treatment option for people living with sickle cell disease.
Key takeaways
- This study evaluates a new medicine, crovalimab, for adults with sickle cell disease.
- The main goal is to see if crovalimab can reduce painful crises (VOEs) and is safe to use.
- It's an early-stage study (Phase II) looking at how the medicine works.
- Participants would take crovalimab alongside their usual sickle cell treatments.
- Results could lead to new treatment options for sickle cell disease.
- Both men and women aged 18 and over are eligible.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older, with a diagnosis of sickle cell disease. Both men and women are welcome to participate. The study is looking for a wide range of adults with this condition, as there isn't an upper age limit mentioned.
The research team will have specific medical criteria to make sure the study medicine is right and safe for you. This often includes looking at your past medical history, current health, and other medications you might be taking. These details help the researchers select people who are most likely to benefit from the study and for whom it will be safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have sickle cell disease?
- Are you willing to take a new study medicine in addition to your current treatments?
- Are you able to attend regular clinic visits for monitoring?
- Are you comfortable reporting your symptoms using a special device at home?
What does participation involve?
If you decide to take part in this study, you will likely have regular visits to a clinic or hospital. During these visits, you will undergo various assessments, such as blood tests to check your overall health and how the medicine is affecting you. You may also be asked to answer questions about your health and how you're feeling using a special device at home, especially about any painful episodes you might experience.
The study involves taking the new medicine, crovalimab, alongside your current treatments for sickle cell disease. You'll be closely monitored by the study team throughout. The full duration of your participation in the study, including all treatments and follow-up assessments, will be explained to you by the research team. This will include how often you need to visit and for how long the treatment period will be.
Potential risks and benefits
Locations (4)
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What are vaso-occlusive episodes (VOEs)?
VOEs are painful crises common in sickle cell disease, caused by blocked blood vessels. They can be very severe and often require hospital visits.
What is crovalimab?
Crovalimab is a new medicine being tested to see if it can help prevent painful crises in people with sickle cell disease.
Who can join this study?
Adults aged 18 and over with sickle cell disease may be able to join. Your doctor will check if you meet all the specific requirements.
Will I still take my regular sickle cell medication?
Yes, in this study, crovalimab is being tested as an 'adjunct treatment,' meaning you would take it in addition to your current sickle cell medications.
What is a 'Phase II' study?
A Phase II study means researchers are still learning about how well a new medicine works and closely monitoring its safety before it moves to larger studies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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