A clinical trial to compare the effectiveness and safety of crovalimab with eculizumab in people with paroxysmal nocturnal hemoglobinuria (PNH)

A Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors.

  • Paroxysmal Nocturnal Hemoglobinuria
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Portugal
  • Saudi Arabia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey
  • United Kingdom
  • United States
Trial Identifier:

NCT04432584 2020-000597-26 BO42161

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 250 participants.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04432584 , BO42161 , 2020-000597-26 Trial Identifier
      All Gender
      No Healthy Volunteers

      How does the COMMODORE 1 clinical trial work?

      This clinical trial is recruiting people who have paroxysmal nocturnal hemoglobinuria (PNH), a blood disorder that involves the breakdown of red blood cells. In order to take part, patients must have been treated with eculizumab for at least 12–24 weeks, or ravulizumab for at least 16 weeks. Patients with a variation in a specific gene (known as C5 polymorphism) can also take part in this trial.

      The purpose of this clinical trial is to compare the effects, good or bad, of crovalimab against eculizumab in patients with PNH. If you take part in this clinical trial, you will receive either crovalimab or eculizumab.

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must have been diagnosed with PNH, and have been treated with eculizumab or ravulizumab before starting the clinical trial.

      You will not be able to take part if you are pregnant or breastfeeding, or have had a disease or disorder affecting your blood system (such as blood clots in the lung/liver/kidney, blocked blood vessels, heart attack) within 6 months before starting the clinical trial. 

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      Your doctor will conduct some tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you will be told about any risks and benefits of participating in the trial. You will also be told what other treatments are available so that you may decide if you still want to participate. 

      While taking part in the clinical trial, you will need to either not have heterosexual intercourse or use contraception for safety reasons. 

      What treatment will I be given if I join this clinical trial?

      This clinical trial is ‘open-label’, which means that everyone involved will know what treatment they are receiving.

      If you join this clinical trial, you will be entered into one of three groups:

      • Group A: you will receive crovalimab, given as an infusion (into the vein) once on Day 1 of the trial, then as an injection under the skin (subcutaneous) once every week for four weeks. After four weeks, crovalimab will be given as a subcutaneous injection once every four weeks for a total of 24 weeks
      • OR Group B: you will receive eculizumab, given as an infusion (into the vein) on Day 1 of the trial, then once every two weeks for a total of 24 weeks 

      If you are in Groups A or B, you must be at least 18 years of age and have been treated with eculizumab for at least 24 weeks before the clinical trial. You will have an equal chance of being placed in Group A or B.

      If you have not been previously treated with eculizumab for at least 24 weeks, you may still join this clinical trial in another group (not random). This third group (Group C) will include:

      • Patients treated with ravulizumab for at least 16 weeks before starting the trial, regardless of age
      • Patients aged less than 18 years old and weighing at least 40kg treated with eculizumab for at least 12 weeks before starting the trial 
      • Patients treated with eculizumab at a higher-than-approved dose for PNH for at least 12 weeks, regardless of age 
      • Patients with a variation in a specific gene (known as C5 polymorphism), and whose condition cannot be controlled well by eculizumab or ravulizumab, regardless of age.

      If you are in Group C, you will be given crovalimab as an infusion (into the vein) once on Day 1 of the trial, then as a subcutaneous injection once every week for four weeks. After four weeks, crovalimab will be given as a subcutaneous injection once every four weeks for a total of 24 weeks.

      After the 24-week primary treatment period, you will have the opportunity to continue crovalimab treatment (Groups A and C) or switch to crovalimab (Group B) for the extension period, if the clinical trial doctor thinks it is in your best interest. Crovalimab may be given in the extension period for a maximum of 5 years, and then until it becomes available in your country and is accessible to you.

      How often will I be seen in follow-up appointments and for how long?

      You will be given the clinical trial treatment crovalimab OR eculizumab for up to 24 weeks in the primary treatment period. During the study, you will need to attend regular visits for treatments and other assessments to see how you are responding to the treatment and any side effects that you may be having, until you complete the study. If you are in Groups A and C, you may continue to receive crovalimab after the 24-week study period has ended if it is in your best interests. If you are in Group B, you will have the option to switch to crovalimab or leave the study after you have completed 10 weeks of safety follow-up. You are free to stop this treatment at any time.  

      What happens if I am unable to take part in clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor may suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04432584?term=crovalimab&draw=2&rank=1

      Trial-identifier: NCT04432584          

      Trial Summary

      A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 250 participants.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04432584 , BO42161 , 2020-000597-26 Trial Identifier
      Crovalimab, Eculizumab Treatments
      Paroxysmal Nocturnal Hemoglobinuria Condition
      Official Title

      A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors.

      Eligibility Criteria

      All Gender
      No Healthy Volunteers
      Inclusion Criteria
      • Body weight >= 40 kg at screening.
      • Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1.
      • Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening.
      • Willingness and ability to comply with all study visits and procedures.
      • Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
      • Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration.
      • Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 6 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label).
      Exclusion Criteria
      • History of allogeneic bone marrow transplantation.
      • History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high.
      • Pregnant or breastfeeding, or intending to become pregnant during the study, within 6 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label).
      • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment.
      • Positive for Active Hepatitis B and C infection (HBV/HCV).
      • Concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study.
      • History of or ongoing cryoglobulinemia at screening.

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