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Monoclonal Antibodies
Crovalimab vs Eculizumab for Paroxysmal Nocturnal Hemoglobinuria (COMMODORE 1 Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body weight >= 40 kg at screening
Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry
Must not have
History of or ongoing cryoglobulinemia at screening
History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
The study compares the safety and effectiveness of Crovalimab to Eculizumab in patients already receiving complement inhibitors for PNH. About 190 participants will receive either Crovalimab or Eculizumab to determine if there's a difference in how they affect the disease.
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as infections due to lowered immunity, allergic reactions during infusion of the drugs, and possibly other unknown risks associated with new medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My body weight is at least 40 kg.
Select...
My PNH diagnosis was confirmed with a specific blood test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of or currently have cryoglobulinemia.
Select...
My condition is classified as intermediate to very high risk according to the IPSS-R for myelodysplastic syndrome.
Select...
I have had a bone marrow transplant from another person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants with Adverse Events (AEs) and by Severity
Side effects data
From 2020 Phase 3 trial • 36 Patients • NCT0201303719%
Bacterial Infections
17%
Viral infections
6%
Fungal infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eculizumab
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (Crovalimab) (Exploratory)Experimental Treatment1 Intervention
Participants will receive a loading series of Crovalimab comprised of an IV dose on Week 1 Day 1, followed by weekly crovalimab SC doses for 4 weeks on Week 1 (Day 2) then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will be administered Q4W thereafter. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.
Group II: Arm A (Crovalimab)Experimental Treatment1 Intervention
Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.
Group III: Arm B (Eculizumab)Active Control1 Intervention
Participants will receive an approved maintenance dose of eculizumab starting on Day 1 and Q2W (every 2 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of study eculizumab treatment, participants will have the option to switch to crovalimab or to discontinue from the study after completion of 10 weeks of safety follow-up.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Paroxysmal Nocturnal Hemoglobinuria (PNH) are complement inhibitors such as Crovalimab and Eculizumab. These treatments work by inhibiting the complement system, specifically targeting the C5 protein to prevent its cleavage into C5a and C5b.
This inhibition is crucial because it stops the formation of the membrane attack complex (MAC), which is responsible for the destruction of red blood cells in PNH patients. By preventing this hemolysis, complement inhibitors reduce symptoms such as anemia, fatigue, and the risk of thrombosis, thereby significantly improving the quality of life and prognosis for PNH patients.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,449 Previous Clinical Trials
1,094,983 Total Patients Enrolled
Chugai PharmaceuticalIndustry Sponsor
97 Previous Clinical Trials
22,254 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,219 Previous Clinical Trials
894,864 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (Eculizumab)
- Group 2: Arm A (Crovalimab)
- Group 3: Arm C (Crovalimab) (Exploratory)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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