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Crovalimab vs Eculizumab for Paroxysmal Nocturnal Hemoglobinuria (COMMODORE 1 Trial)
COMMODORE 1 Trial Summary
This trial will compare crovalimab with eculizumab to see if one is better than the other at treating PNH (a disease caused by a faulty protein). 250 people will be enrolled.
COMMODORE 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMMODORE 1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 36 Patients • NCT02013037COMMODORE 1 Trial Design
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- My body weight is at least 40 kg.I have a history of or currently have cryoglobulinemia.I am willing and able to follow all study requirements.I agree to avoid pregnancy or use birth control during and after treatment.Your lactate dehydrogenase levels are not more than twice the upper limit of normal.My condition is classified as intermediate to very high risk according to the IPSS-R for myelodysplastic syndrome.My PNH diagnosis was confirmed with a specific blood test.I have been treated with eculizumab or ravulizumab for PNH for at least 3 months.I have been vaccinated against meningitis within the last 3 years, or I can get vaccinated within a week after starting the study treatment.I have had a bone marrow transplant from another person.You have a current hepatitis B or C infection.
- Group 1: Arm A (Crovalimab)
- Group 2: Arm B (Eculizumab)
- Group 3: Arm C (Crovalimab) (Exploratory)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can you provide some background on other Crovalimab research studies?
"The first study involving Crovalimab was completed in 2016 at Tokyo Medical University Hospital. As of now, there have been a total of 43 completed studies. Additionally, there are 20 active studies being conducted with several of them located in Ste-Foy, Quebec."
What are some of the conditions that Crovalimab has shown to be effective in treating?
"Crovalimab is a common intervention for myasthenia gravis, generalized. It can also be used to treat neuromyelitis optica, paroxysmal nocturnal haemoglobinuria (pnh), thyroid stimulating immunoglobulins, and other conditions."
Is this a groundbreaking or innovative clinical trial?
"There are 20 ongoing clinical trials for Crovalimab being conducted in 43 different countries. The first study was sponsored by Hoffmann-La Roche in 2016 and completed Phases 1 & 2. Since then, 43 more trials have completed."
Which areas are hosting this research project?
"There are a dozen hospitals participating in this clinical trial, some of which are CHUQ - Hôtel-Dieu de Québec in Ste-Foy, Medical College of Wisconsin, Inc. in Milwaukee, and Nationwide Children's Hospital; Dept. of Pulmonology in Columbus."
Has Crovalimab received the go-ahead from the FDA?
"Crovalimab has received a safety score of 3. This is due to the number of Phase 3 trials that have been conducted, demonstrating its efficacy and safety."
If a patient meets the eligibility requirements, can they sign up for the trial currently?
"Yes, this information can be found on the website clinicaltrials.gov. The study was originally published on September 30th, 2020 and was updated as recently as September 23rd, 2022."
How many individuals are being treated for this illness in this study?
"Yes, the online information confirms that this study is open for recruitment and has been since 30th September 2020. The last update to the trial's information was on 23rd September 2022. They are looking for a total of 250 individuals to participate across 12 different centres."
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