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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive either the test medication, known as anumigilimab (50 mg administered as a solution for injection under the skin), or a placebo, which is a saline solution (salt water) that contains no active medicine.

    The method of administration is subcutaneous, which means the injection is given into the fatty tissue just under the skin.

  2. Step 2

    Maintenance period

    Following the initial phase, a 52-week maintenance period occurs.

    During this time, the focus is on monitoring the annualized rate of vaso-occlusive crises, which are sudden episodes of intense pain caused by blood cells blocking blood flow in the vessels.

  3. Step 3

    Safety and monitoring

    Throughout the study, up to week 65, blood tests are performed to measure the levels of anumigilimab in the blood.

    Regular assessments are conducted to monitor vital signs (such as blood pressure and heart rate) and laboratory assessments (blood and urine tests) to track any changes from the start of the study.

    Any adverse events, which are side effects or unintended medical occurrences, are recorded to assess the safety of the medication.

Who can join the trial?

8 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

Anumigilimab - This medication is an injectable solution administered through a needle under the skin and is currently being studied in clinical trials to treat sickle cell disease. It belongs to a class of drugs known as monoclonal antibodies, which work by attaching to specific proteins in the body to help regulate the immune system. By targeting these molecules, the drug aims to reduce the harmful effects associated with sickle cell disease. Saline 0.9% - This is a sterile salt-water solution used as a placebo in this study to provide a comparison for the active treatment. It is administered via injection but contains no active medicinal ingredients to treat any specific disease. It is widely used in medical settings as a neutral liquid for various purposes, such as keeping tissues moist or delivering other medicines.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521154-42-00Protocol codeCSL324_2002Estimated enrolment63 patientsSponsorCSL Behring LLC

sourced from the EU Clinical Trials Register and site verification

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