RecruitingPHASE2INTERVENTIONAL

Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)

This study, called a Phase 2 trial, is looking at a new medicine called Anumigilimab for adults living with sickle cell disease. The main goal is to check how safe Anumigilimab is when given under the skin. Some participants will receive the active medicine, while others will get a placebo (a dummy medicine without any active ingredients). This helps researchers understand the medicine's true effects. The study will last for 64 weeks, which is about 15 months. During this time, the dose of Anumigilimab will be slowly increased to find the best tolerated amount, and then participants will continue on that dose. This research is important for finding new ways to manage sickle cell disease.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

CSL Behring

Enrolment target

Start

02 Feb 2026

Estimated completion

29 Jun 2028

Sickle Cell Disease

What is this study about?

This study is a Phase 2 trial, which means it's an early but important step in developing new medicines. For adults with sickle cell disease, researchers are looking at a new drug called Anumigilimab. The main purpose of this study is to carefully check if Anumigilimab is safe for people with sickle cell disease. It's designed to be a thorough investigation into any potential side effects.

Participants will be given the study medicine, or a placebo (an inactive substance that looks just like the study medicine), as an injection under the skin. This approach helps researchers to accurately compare the effects of the new medicine against no active treatment, without anyone knowing who is receiving which, until the study is over. The study will last for a total of 64 weeks, which is a bit over a year. During the first 12 weeks, the dose of the medicine will be gradually increased to find the highest amount that each person can comfortably take. After this, participants will continue on that dose for the remaining 52 weeks.

Finding new, safe, and effective treatments for sickle cell disease is really important for improving the lives of those affected. Studies like this help us understand if new medicines could be a good option for the future. By carefully observing participants and gathering information on how they respond to Anumigilimab, researchers hope to learn more about its potential role in managing sickle cell disease.

Key takeaways

This study is testing a new medicine called Anumigilimab for sickle cell disease.
The main goal is to check how safe the medicine is.
Participants will receive the medicine or a placebo as an injection under the skin.
The study lasts for 64 weeks (about 15 months).
It's for adults aged 18 and over with sickle cell disease who have experienced pain crises.
This research is an important step in finding new treatments for sickle cell disease.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have a confirmed diagnosis of sickle cell disease, no matter your specific type. You should also have experienced a certain number of pain crises (called VOCs) in the past year that required medical help and strong pain relief.

You might be taking a medicine called Hydroxyurea (HU) – if so, you need to have been on a stable dose for at least a month. If you've stopped taking HU, or if it wasn't right for you, you might still be able to join. Your doctor will check if you meet all the health requirements to ensure the study is safe for you.

There are also a few reasons why someone might not be able to join. For example, if your white blood cell count (a type of blood cell) is too low, or if you've recently changed your dose of other sickle cell preventive medicines, you might not be eligible. These rules are in place to keep everyone safe and make sure the study results are clear.

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 a confirmed diagnosis of sickle cell disease?
Have you had 1 to 12 pain crises (VOCs) that needed medical help in the last year?
Are you on a stable dose of Hydroxyurea for at least 30 days, or have you stopped/refused it?
Do you have a healthy enough white blood cell count (neutrophils)?
Have you been on a stable dose of any other sickle cell preventive medicines for at least 30 days?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be in it for a total of 64 weeks, which is about 15 months. For the first 12 weeks, you'll have regular visits where the dose of the study medicine will be slowly increased to find the best amount for you. After that, you'll continue on that dose for the remaining 52 weeks.

Throughout the study, you'll receive the medicine (either Anumigilimab or a placebo) as an injection under your skin. You'll have regular check-ups with the study team. These visits will involve various tests and assessments, such as blood tests, to monitor your health and see how you are responding to the treatment. The research team will explain the full schedule of visits and what each visit will involve in detail.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and contributing to medical research that could help others with sickle cell disease in the future. However, there are also potential risks, including side effects from the study medicine, which may not yet be fully known. You might also receive a placebo, meaning you won't get the active medicine. The research team will explain all known risks and discomforts involved. Remember, joining is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (16)

UAMS Medical Center
Verified postcode
Little Rock, United States· Recruiting
University of California Irvine
Verified postcode
Orange, United States· Recruiting
The Foundation for Sickle Cell Disease
Verified postcode
Hollywood, United States· Recruiting
Arthur M. Blank Hospital- Children's Healthcare of Atlanta
Verified postcode
Atlanta, United States· Recruiting
Center for Cancer and Blood Disorders
Verified postcode
Bethesda, United States· Recruiting
Southern Specialty Research
Verified postcode
Flowood, United States· Recruiting
Jacobi Medical Center
Verified postcode
The Bronx, United States· Recruiting
Ohio State University
Verified postcode
Columbus, United States· Recruiting
Virginia Commonwealth University
Verified postcode
Richmond, United States· Recruiting
CHU Saint-Pierre
Verified postcode
Brussels, Belgium· Recruiting
CHU de Nantes, Hotel-Dieu
Verified postcode
Nantes, France· Recruiting
Institut Universitaire du Cancer de Toulouse
Unverified
Toulou, France· Recruiting

Common questions

What is Anumigilimab?

Anumigilimab is an investigational medicine being studied for sickle cell disease. It's not yet approved for general use.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new drug.

Why is this called a 'Phase 2' study?

Phase 2 studies are an early stage of research focusing on finding the right dose and further checking the safety of a new medicine in a larger group of people.

Will I know if I'm getting the actual medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you're receiving Anumigilimab or the placebo until the study ends.

How will the medicine be given?

The study medicine will be given as an injection under the skin.

How to find out more

Trial Registration Coordinator

clinicaltrials@cslbehring.com +1 610-878-4697 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.