A study to assess the safety of Anumigilimab in adults with sickle cell disease

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What is this study about?

This study focuses on individuals living with Sickle Cell Disease, a condition that affects red blood cells, causing them to become misshapen like a crescent moon. This shape can lead to complications such as a vaso-occlusive crisis, which is a painful episode caused by blood cells getting stuck in small blood vessels. The purpose of the study is to assess the safety of the drug anumigilimab, also known as CSL324.

Participants will be assigned to receive either anumigilimab or a placebo through a subcutaneous injection, which means the medication is administered just under the skin. The study uses a double-blind method, meaning neither the participants nor the researchers know which substance is being given at any given time. This process helps ensure that the results are as accurate as possible.

During the course of the study, the effects of the medication will be monitored over time. This includes observing any adverse events, which are unintended side effects or medical problems that may occur during the treatment. The study will track how the body responds to the injection and monitor general health markers to ensure participant safety.

Who Can Join the Study?

  • You must be an adult, meaning you are 18 years of age or older on the day you sign the permission form.
  • You must have a confirmed diagnosis of Sickle Cell Disease (SCD), which is a blood disorder where red blood cells become misshapen.
  • You must have had between 1 and 12 vaso-occlusive crises (VOCs) in the last 12 months. A vaso-occlusive crisis is a painful episode caused when sickle-shaped blood cells block blood flow.
  • Those painful episodes must have required a visit to a medical facility and treatment with parenteral medications. Parenteral means medicine that is given by injection or through an IV rather than by mouth.
  • The medications used for those episodes must have been opioids (strong pain medicines) or nonsteroidal anti-inflammatory drugs (NSAIDs) (medicines used to reduce pain and swelling).
  • Regarding Hydroxyurea (HU), which is a common medication used to treat this condition, you must either:
  • Have been taking a stable and well-tolerated dose of Hydroxyurea for at least 30 days before the study begins. Stable and well-tolerated means your dose has stayed the same and you have not had bad reactions to it.
  • Or, you must have stopped taking Hydroxyurea or chosen not to take it because of concerns about side effects (unwanted reactions to a drug) or because it was not working for you.

Who Cannot Join the Study?

  • Your absolute neutrophil count, which is a measure of the white blood cells that help your body fight infections, is less than 2.5 ×10^9 cells/Litre at the start of the study.
  • You are taking medicine to prevent complications from Sickle Cell Disease, but your dose has not stayed the same for at least the last 30 days.
  • You have had a myeloproliferative disorder, which is a type of blood cancer where the bone marrow makes too many blood cells, or a malignancy, which is another word for cancer (excluding skin cancer), within the last 5 years.
  • You have a history of receiving a stem cell transplant, which is a procedure to replace damaged bone marrow with healthy cells, or gene therapy, which is a medical technique that uses genes to treat or prevent disease.
  • Your hemoglobin level, which is a protein in your red blood cells that carries oxygen throughout your body, is less than 6.5 g/dL at the start of the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
CHU Saint Pierre Brussels Belgium
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Universita’ Degli Studi Di Ferrara Ferrara Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Aiutils Oncsufaofvz Okaktnoj Rzbapte Vdicj Soazq Chnaatgy Palermo Italy
Aeuqiohkh Uqv Amsterdam The Netherlands
Arukygyzef Phgdeute Hosgfmfd Dz Mweqqipdg Marseille France
Uzwyrjajrp Ou Ajioatp Edegem Belgium

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
30.05.2026
France France
Not yet recruiting
30.05.2026
Italy Italy
Not yet recruiting
30.05.2026
The Netherlands The Netherlands
Not yet recruiting
30.05.2026

Trial locations

Investigated drugs:

Anumigilimab is an experimental medicine being tested to see if it is safe for adults living with sickle cell disease. It is given as an injection under the skin.

Sickle Cell Disease – This condition is caused by an abnormality in the hemoglobin, which is the protein in red blood cells that carries oxygen. The abnormal hemoglobin causes the red blood cells to become stiff and shaped like crescents or sickles. These irregularly shaped cells can get stuck in small blood vessels, blocking the flow of blood. This blockage can lead to episodes of intense pain. Over time, the cells break down more quickly than normal, which can affect the body’s ability to transport oxygen effectively.

Trial ID:
2025-521154-42-00
Protocol code:
CSL324_2002
NCT ID:
NCT07224360
Trial Phase:
Therapeutic exploratory (Phase II)

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