Clinical trials with Ravulizumab

  • CT-EU-00114975

    Study on Ravulizumab’s effect on Immunoglobulin A Nephropathy

    The study is looking into the effectiveness of a medication called ravulizumab for adults who have a kidney condition known as Immunoglobulin A Nephropathy (IgAN). This condition can lead to kidney damage over time, and the study aims to find out if ravulizumab can help reduce the amount of protein lost in urine—a common problem in IgAN—and slow down the decrease in kidney function.

    In this study, about 450 participants who are at a high risk of their disease getting worse will be chosen. These participants must have been on stable treatment for their IgAN for at least three months before the study starts. They will then receive either ravulizumab or a placebo, which is a treatment with no active drug, through an IV infusion based on their weight. The main goal is to see if those who receive ravulizumab have a significant improvement in their condition compared to those who receive the placebo.

    The study will have two main checkpoints. The first one, at Week 34, will check how much protein is in the urine, and the second one, at Week 106, will assess how well the kidneys are filtering waste from the blood. Additionally, a smaller group of participants with more advanced kidney issues will receive ravulizumab to further explore its effects.

    After the study ends at Week 106, participants will have the option to continue receiving ravulizumab in a follow-up period to see how long-term treatment affects their condition. This study is a chance for people with IgAN to potentially slow down their disease progression and improve their quality of life.

    • placebo
    • Ravulizumab
  • ARTEMIS study: Protecting kidney health in heart surgery patients with Ravulizumab

    The ARTEMIS study aims to find a new way to protect people with chronic kidney disease (CKD) undergoing heart surgery requiring the use of a heart-lung machine, also known as cardiopulmonary bypass (CPB). The main aim of this study is to see if a single dose of a drug called ravulizumab given intravenously can reduce the risk of serious kidney problems after surgery, compared with a placebo. Kidney issues are grouped under serious adverse events, and investigators will monitor them for up to 90 days after surgery. The study is carefully controlled and participants will not know whether they are receiving ravulizumab or a placebo to ensure the results are unbiased. This is an important test for people with chronic kidney disease undergoing heart surgery because it may lead to better outcomes and a lower risk of kidney damage after surgery.

    • placebo
    • Ravulizumab
  • Testing ravulizumab for transplant-related blood complications

    The study is examining a drug called ravulizumab used in adults and teenagers with a blood vessel disease called thrombotic microangiopathy (TMA) after a bone marrow transplant. Sometimes, new cells growing after a bone marrow transplant can cause problems in the blood vessels leading to TMA. So this study will investigate whether ravulizumab can help in this situation. In the first stage, each participant will receive the drug to determine the best dose. In the second phase, some will receive ravulizumab and best supportive care, while others will receive placebo and best supportive care. After 26 weeks of treatment, doctors will continue to monitor and record the patients’ health for another 26 weeks. Special blood tests will be done to check if the medicine is working.

    • Ravulizumab
  • Study on a new drug’s effect in Paroxysmal Nocturnal Hemoglobinuria

    This study is looking at how safe and effective a new drug called OMS906 is for people with a type of blood disorder where red blood cells break down too early, known as Paroxysmal Nocturnal Hemoglobinuria (PNH). This is especially for those who have not responded well to another type of medication called ravulizumab. The aim of this phase 1b study is to figure out the drug’s side effects, how the body handles the drug, how the drug works in the body, and how well the drug works in treating PNH. The test is done using two different doses of the medicine, first used together with ravulizumab, then on its own. They will keep track of any side effects, alterations in lab tests, electrocardiograms, and physical exams. They will also monitor changes in patients’ red blood cells, a blood chemical marker, and the number of transfusions needed. The levels of OMS906 and certain biological markers will be measured in the blood.

    • OMS906
    • Ravulizumab