AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease

This important study is looking for adults aged 18 and over who have sickle cell disease. We are testing a new medicine called anumigilimab to see how safe it is and how well people tolerate it. Participants will be randomly given either the new medicine or a dummy treatment (placebo) without knowing which they receive. Our main goal is to carefully track any side effects that might happen. We'll also be doing various health checks, like blood tests, to make sure everything is okay. Over time, we will also track how the medicine levels are in the body and if it helps reduce painful episodes experienced by people with sickle cell disease. This is a crucial step in learning if this new treatment could help people in the future.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

CSL Behring LLC

Enrolment target

Start

28 Apr 2026

Sickle Cell Disease

What is this study about?

Imagine you have sickle cell disease, where your red blood cells can become stiff and shaped like a crescent moon, causing pain and other health problems. Researchers are always looking for new ways to make life better for people living with this condition. This particular study is an early-stage trial, which means it's one of the first times this new medicine, called anumigilimab, is being tested in a larger group of people with sickle cell disease.

The main aim of this study is to very carefully check the safety of anumigilimab. This involves looking closely at any side effects participants might experience, whether they are mild or more serious. We'll also be tracking how the new medicine affects important health markers, like blood test results and vital signs (such as blood pressure and heart rate). Some participants will receive the new medicine, while others will receive a dummy treatment (placebo) – neither you nor the study team will know who gets what until the end. This is a standard and important way to fairly compare the effects of the new medicine.

While the main focus is on safety, researchers will also be gathering information about how the new medicine moves through your body and how long it stays there. They will also be looking at whether it has any impact on the frequency of painful episodes, called 'crises,' that people with sickle cell disease can experience. The information gathered from studies like this one is vital for deciding if a new medicine has the potential to help patients and should be studied further.

Key takeaways

This study is testing a new medicine, anumigilimab, for safety in adults with sickle cell disease.
It's an early-stage study (Phase 2a) focused on understanding side effects and how the medicine works.
Participants will receive either the new medicine or a dummy treatment (placebo).
Regular health checks, including blood tests and vital signs, will be carried out.
The study also aims to see if the medicine might help reduce painful sickle cell crises.
Your involvement helps advance medical understanding for future treatments.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years and above, who have been diagnosed with sickle cell disease. Both men and women are welcome to take part.

To be considered for this study, you would need to meet certain health criteria that the study doctors will check. This is to make sure the study tests the medicine on the right people and keeps everyone as safe as possible.

There might be some reasons why you couldn't join, for example, if you have certain other medical conditions or are taking specific medications that could interfere with the study medicine. The research team will discuss all of these details with you thoroughly.

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?
Have you been diagnosed with sickle cell disease?
Are you currently living in the UK?
Are you able to attend regular clinic appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine (anumigilimab) or a dummy treatment (saline, which is just saltwater, given in the same way). You won't know which one you're getting, nor will the study team, to make sure the results are fair.

Your participation would involve regular visits to the study clinic over a period of time. During these visits, you'd have examinations, blood tests, and other checks to monitor your health and how your body is reacting. This could include measuring your vital signs like blood pressure and temperature. You would also be asked to report any changes in your health or any side effects you might experience.

The study would involve receiving the treatment for a set period, followed by a time where the study team continues to monitor your health and collect information, even after you've finished taking the medicine. The total duration of your involvement could be around 65 weeks, but the study team will explain the exact schedule in detail.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. You might not directly benefit from taking the study medicine, as it's still in an early testing phase and you might receive the placebo. However, your participation would contribute greatly to medical knowledge, which could help people with sickle cell disease in the future. Potential risks include experiencing side effects from the study medicine, which the research team will monitor very closely. There are also risks associated with various procedures like blood tests, such as bruising or discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Belgium
—
Unverified
Netherlands
—
Unverified
France
—
Unverified
Italy

Common questions

What is sickle cell disease?

Sickle cell disease is a condition where red blood cells, which carry oxygen, are shaped like a crescent moon, causing pain and other health problems.

What is a 'Phase 2a' study?

This is an early stage of testing a new medicine, mainly to check if it's safe for people and what doses might be helpful.

What does 'placebo-controlled' mean?

It means some people get the new medicine, and others get a dummy treatment that looks the same, so we can fairly compare the results.

Will I know if I'm getting the real medicine or the dummy treatment?

No, neither you nor the doctors will know until the study is over. This is called 'double-blind' and helps keep the study fair.

How long would I be in the study?

Your involvement in the study could last for about 65 weeks, including follow-up appointments.