Crovalimab vs Eculizumab for Paroxysmal Nocturnal Hemoglobinuria
(COMMODORE 1 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must have been treated with eculizumab or ravulizumab for at least 3 months before starting the study.
What data supports the effectiveness of the drug Crovalimab for treating paroxysmal nocturnal hemoglobinuria?
Eculizumab, a similar drug to Crovalimab, has been shown to significantly improve survival and quality of life for patients with paroxysmal nocturnal hemoglobinuria by reducing blood cell destruction and the risk of blood clots. This suggests that Crovalimab, which is being compared to Eculizumab, may also be effective in treating this condition.12345
Is Crovalimab or Eculizumab safe for humans?
How does the drug Crovalimab differ from Eculizumab for treating paroxysmal nocturnal hemoglobinuria?
Crovalimab is a newer treatment option for paroxysmal nocturnal hemoglobinuria (PNH) that may offer different dosing schedules or mechanisms compared to Eculizumab, which is known for its ability to block the breakdown of red blood cells and improve quality of life. While Eculizumab requires frequent infusions, newer treatments like Ravulizumab, which is similar to Crovalimab, offer less frequent dosing, potentially improving convenience and quality of life for patients.12349
What is the purpose of this trial?
This trial is testing the safety of crovalimab and eculizumab in patients with PNH who are already on medications. Both drugs work by stopping the immune system from destroying red blood cells. Eculizumab, a medication that was first approved for PNH in 2007, has revolutionized the treatment of this disease.
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for adults with PNH who weigh at least 40 kg and have been treated with eculizumab or ravulizumab for over 3 months. They should have stable lactate dehydrogenase levels and be vaccinated against Neisseria meningitidis. Pregnant women, those planning pregnancy, or breastfeeding are excluded, as well as individuals with certain medical conditions or treatments that could interfere.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either crovalimab or eculizumab for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants who benefit from crovalimab may continue treatment
Treatment Details
Interventions
- Crovalimab
- Eculizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Chugai Pharmaceutical
Industry Sponsor
Dr. Osamu Okuda
Chugai Pharmaceutical
Chief Executive Officer since 2020
MD from Kyoto University
Dr. Mariko Y. Momoi
Chugai Pharmaceutical
Chief Medical Officer
MD from Jichi Medical University