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Study on the Safety and Effectiveness of CSL889 for Adults and Adolescents with Sickle Cell Disease During Painful Crises

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What is this trial about?

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

This clinical trial is focused on studying sickle cell disease, a genetic condition that affects the red blood cells, leading to episodes of severe pain known as vaso-occlusive crises. The study will evaluate a treatment called CSL889, which is a form of hemopexin, human, a protein that may help manage these painful episodes. The treatment is given as a solution through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein.

The purpose of the study is to assess the safety and effectiveness of CSL889 in helping to resolve vaso-occlusive crises in people with sickle cell disease. Participants in the study will receive either the CSL889 treatment or a placebo, which is a solution that does not contain the active substance. The study will monitor how quickly the painful episodes resolve and will also track any side effects that may occur.

Participants will be involved in the study for a period of time during which they will receive multiple doses of the treatment. The study will also collect information on how the body processes the treatment, known as pharmacokinetics. This includes measuring the concentration of CSL889 in the blood at different times. The study aims to provide valuable information on whether CSL889 can be a safe and effective treatment option for managing vaso-occlusive crises in sickle cell disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, diagnosis of sickle cell disease, and the presence of a new acute vaso-occlusive crisis requiring treatment with opioids.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the study medication, CSL889 (human hemopexin), or a placebo (a solution without active substance). This process is double-blind, meaning neither you nor the study team will know which treatment you receive.

  4. Step 4

    Treatment administration

    The treatment will be administered through an intravenous infusion. The frequency and dosage will be determined by the study protocol, and you will receive multiple doses over the course of the study.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, you will be closely monitored for any side effects or changes in your condition. Regular assessments will be conducted to evaluate the safety and effectiveness of the treatment, including measuring the time to resolution of the vaso-occlusive crisis and any adverse events.

  6. Step 6

    Completion of the study

    Upon completion of the study, a final assessment will be conducted. This will include a review of your overall health and any changes observed during the trial. You will be informed about the next steps and any additional follow-up that may be required.

Who can join the trial?

4 criteria

  • Must be at least 18 years old or between 12 and 17 years old if approved for adolescents.
  • Must have been diagnosed with sickle cell disease (SCD). This is a group of inherited red blood cell disorders.
  • Must be experiencing a new acute vaso-occlusive crisis (VOC). This is a sudden episode of pain that occurs when blood flow is blocked in small blood vessels.
  • Must need treatment with parenteral opioids. These are strong pain medications given by injection.

Who cannot join the trial?

8 criteria

  • Patients who do not have sickle cell disease cannot participate. Sickle cell disease is a condition where red blood cells, which carry oxygen around the body, are shaped like a sickle or crescent, which can block blood flow.
  • Patients who are not experiencing a vaso-occlusive crisis cannot participate. A vaso-occlusive crisis is a painful episode that occurs when blood flow is blocked by sickle-shaped cells.
  • Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups, but the exact ages are not provided here.
  • Patients who are not willing or able to receive medication through an intravenous (IV) infusion cannot participate. An IV infusion is a way to deliver medication directly into the bloodstream through a vein.
  • Patients who are not able to follow the study procedures or attend all required visits cannot participate.
  • Patients who have any other medical conditions or are taking medications that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
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Investigated drugs

CSL889 is a medication being tested in this clinical trial. It is a form of human hemopexin, which is a protein that naturally occurs in the body. In this study, CSL889 is given to participants through an intravenous (IV) infusion. The main goal of using CSL889 is to see if it can help people with sickle cell disease recover faster from a painful episode known as a vaso-occlusive crisis. This crisis happens when the blood flow is blocked by sickle-shaped cells, causing pain and other complications. The study aims to find out if CSL889 can safely and effectively reduce the time it takes for these crises to resolve.

What is already known about the treatment

CSL889 – CSL889 is administered through an intravenous (IV) infusion, meaning it is delivered directly into the bloodstream via a vein. Currently, CSL889 is being studied in clinical trials to assess its safety and effectiveness in treating sickle cell disease, specifically during a vaso-occlusive crisis, which is a painful complication of the disease. The main therapeutic use of CSL889 is to help resolve these painful episodes more quickly. At the molecular level, CSL889 works by using human hemopexin, a protein that helps manage the levels of free heme in the blood, which can be elevated during a vaso-occlusive crisis. This medication is classified pharmacologically as a heme-binding protein therapy.

Investigated diseases

Sickle cell disease vaso-occlusive crisis – This condition occurs in individuals with sickle cell disease, a genetic disorder affecting hemoglobin in red blood cells. During a vaso-occlusive crisis, the sickle-shaped red blood cells block small blood vessels, leading to reduced blood flow and oxygen delivery to tissues. This blockage causes severe pain and can affect various parts of the body, including the bones, lungs, and abdomen. The crisis can be triggered by factors such as dehydration, infection, or stress. It typically progresses with episodes of acute pain that can last from hours to days. Repeated episodes can lead to complications affecting organs and overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-513440-29-00Protocol codeCSL889_2001Estimated enrolment260 patientsSponsorCSL Behring LLC

sourced from the EU Clinical Trials Register and site verification

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