A study of the safety and efficacy of corvalimab compared with eculizumab in people with paroxysmal nocturnal hemoglobinuria

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    What is this study about?

    This clinical study aims to evaluate the safety and efficacy of crovalimab vis-à-vis eculizumab in managing paroxysmal nocturnal hemoglobinuria (PNH), an uncommon genetic blood disorder. The study welcomes participants who’ve been receiving treatment for PNH with either eculizumab or ravulizumab for no less than three months. Also, the lactate dehydrogenase levels of the participants need to be within the threshold of twice the upper limit of normal. An agreement to fully abide by all the study visits and procedures is mandatory for interested participants. Women of childbearing potential must agree to either stay abstinent or use contraception throughout the study and for a certain period after the last dosage.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Bruxelles , Belgium

      Roeselare , Belgium

      Yvoir , Belgium

      Praha , Czechia

      Lille , France

      Marseille , France

      Rennes cedex 9 , France

      Aachen , Germany

      Essen , Germany

      Riesa , Germany

      Ulm , Germany

      Alexandroupolis , Greece

      Athens , Greece

      Chaidari , Greece

      Larissa , Greece

      Thessaloniki , Greece

      Budapest , Hungary

      Ravenna , Italy

      Roma , Italy

      Milano , Italy

      Torino , Italy

      Florence , Italy

      Amsterdam , Netherlands

      Bydgoszcz , Poland

      Gdansk , Poland

      Krakow , Poland

      Lublin , Poland

      Sku00f3rzewo , Poland

      Warszawa , Poland

      Porto , Portugal

      Badalona , Spain

      Esplugues De Llobregas , Spain

      Santiago de Compostela , Spain

      Las Palmas de Gran Canaria , Spain

      Bilbao , Spain

      Asturias , Spain

      Barcelona , Spain

      Caceres , Spain

      Madrid , Spain

      Madrid , Spain

      Malaga , Spain

      Salamanca , Spain

      Sevilla , Spain

      Toledo , Spain

      Valencia , Spain

      Zaragoza , Spain

      Uppsala , Sweden

      London , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take within this clinical trial for the administration of Crovalimab are as follows:

      – On Week 1 Day 1, Crovalimab will be administered at a dose of 1000 mg intravenously (IV) for participants with a body weight between 40 and 100 kg, or 1500 mg IV for those with a body weight of 100 kg or more.
      – On Week 1 Day 2, and on Weeks 2, 3, and 4, Crovalimab will be administered at a dose of 340 mg subcutaneously (SC).
      – Starting on Week 5 and every 4 weeks (Q4W) thereafter, the dose will be administered subcutaneously. The document did not specify the subcutaneous dose for Week 5 onward, so further information would be needed to provide the exact dosing schedule beyond the initial 4 weeks.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you must have a documented diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH), confirmed by high sensitivity flow cytometry .


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      ### Inclusion Criteria:

      • Body weight ≥ 40 kg at screening: You must weigh at least 40 kilograms at the time of screening for participation in the study.
      • Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1: You should have received treatment with either eculizumab or ravulizumab, two drugs used to treat Paroxysmal Nocturnal Hemoglobinuria (PNH), for at least three months before the first day of the study. PNH is a rare, life-threatening blood disease characterized by destruction of red blood cells, blood clots, and impaired bone marrow function.
      • Lactate Dehydrogenase Levels ≤ 2x the upper limit of normal (ULN) at screening: Lactate Dehydrogenase (LDH) is an enzyme found in almost all body tissues, and its levels are measured to assess the extent of tissue damage. Your LDH levels must be less than or equal to twice the upper limit considered normal when you are screened.
      • Willingness and ability to comply with all study visits and procedures: You must be willing and able to follow all the scheduled study visits and procedures as outlined by the clinical trial protocol.
      • Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry: You need to have a confirmed diagnosis of PNH, as validated by a sensitive laboratory test called flow cytometry that analyzes the characteristics of cells.
      • Vaccination against Neisseria meningitidis serotypes A, C, W, and Y: You should be vaccinated against Neisseria meningitidis, a bacterium that can cause meningitis and other forms of meningococcal disease. The vaccination should protect against at least four serotypes of this bacterium: A, C, W, and Y.

      What Reasons Could Exclude Me from the Study?

      Here’s a list of conditions that would exclude you from participating in the study, with explanations of the medical terms:

      History of allogeneic bone marrow transplantation: You cannot participate if you have received a bone marrow transplant from another person (donor).

      History of myelodysplastic syndrome with IPSS-R prognostic risk categories of intermediate, high and very high: Myelodysplastic syndrome (MDS) is a group of disorders caused by poorly formed or dysfunctional blood cells. The Revised International Prognostic Scoring System (IPSS-R) is used to determine the severity of MDS. If you have an intermediate, high, or very high risk of MDS, you cannot take part in the study.

      Pregnant or breastfeeding, or intending to become pregnant: If you are pregnant or breastfeeding, or plan to become pregnant within 10.5 months after the final dose of crovalimab or 3 months after the final dose of eculizumab, you are excluded.

      Participation in another interventional treatment study: You cannot join this study if you are participating in another research study involving an experimental treatment, unless you were part of an eculizumab or ravulizumab study and agree to stop that to join this one.

      Positive for Active Hepatitis B and C infection (HBV/HCV): An active infection with hepatitis B or C viruses disqualifies you from the study.

      Concurrent disease, treatment, or abnormal lab tests that could interfere with the study: If you have any other medical conditions, treatments, or surgeries, or if your lab tests show abnormalities that might affect the study procedures or pose additional risks to your health, you will be excluded.

      History of or ongoing cryoglobulinemia: Cryoglobulinemia is a condition characterized by the presence of abnormal proteins in the blood that can precipitate in cold temperatures, causing various symptoms. If you have a history of, or currently have this condition, you cannot participate in the study.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      • The drugs involved in the study are Crovalimab and Eculizumab.
      • Crovalimab:

        This is an experimental drug used in the trial. Crovalimab will be administered at varying doses based on the participant’s body weight (with specific doses for those with body weight between 40 and 100kg or those with body weight greater than 100kg). It will be given intravenously (IV) on the first day, followed by weekly subcutaneous (SC) doses for the first 4 weeks. Maintenance SC dosing will begin at Week 5 and will continue every 4 weeks (Q4W) for a total of 24 weeks. After 24 weeks, participants who benefit from the drug may continue to receive it.

      • Eculizumab:

        This is the active comparator drug in the trial. Eculizumab is an FDA-approved medication and will be administered at a dose of 900 mg every 2 weeks for a total of 24 weeks as per the dosing schedule described. After 24 weeks, participants will have the option to switch to Crovalimab or to discontinue from the study after a safety follow-up period.

      • The role of each drug in the study:
      • Crovalimab

        is being tested for its safety, pharmacokinetics, and efficacy as a potential treatment for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who are currently treated with complement inhibitors.

      • Eculizumab

        serves as the active comparator in the study to help determine whether Crovalimab offers an improved treatment option for the same patient population. It is a complement inactivating agent and also an immunosuppressive agent currently approved for the treatment of PNH.

      • Please, let me know if you need further details about the clinical trial or any additional information regarding these drugs.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves two active substances:

      • Crovalimab: This is an experimental substance currently being studied for its safety, pharmacokinetics, and efficacy. As the trial involves a “loading series” of the drug and subsequent maintenance doses, it is not yet a standard therapy and may not be widely known or available in general medical practice.
      • Eculizumab: Participants will receive an approved maintenance dose of eculizumab, suggesting that this substance is already known to medicine and the medical literature, as it is used under an approved dosing regimen. Eculizumab is an established treatment for certain conditions, including paroxysmal nocturnal hemoglobinuria (PNH), and has been studied and described extensively in scientific studies and medical literature prior to this trial.

      Study ID

      CT-EU-00022232

      Recruitment status

      Recruting new patients

      Start of the trial

      4 years ago

      Study phase

      Phase
      III

      Medicinal Product