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Monoclonal Antibodies
Crovalimab vs Eculizumab for Paroxysmal Nocturnal Hemoglobinuria (COMMODORE 2 Trial)
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6.5 years
Awards & highlights
COMMODORE 2 Trial Summary
This trial will compare crovalimab with eculizumab to see if one is better than the other at treating PNH in people who haven't taken complement inhibitor therapy before.
Who is the study for?
This trial is for individuals with Paroxysmal Nocturnal Hemoglobinuria (PNH) who haven't been treated with complement inhibitors before. They must be willing to follow the study's procedures, weigh at least 40 kg, have certain vaccination against meningitis, and not be pregnant or breastfeeding. People previously treated with similar drugs or having certain health conditions are excluded.Check my eligibility
What is being tested?
The trial is testing Crovalimab against Eculizumab in about 200 participants to see if it's just as effective for PNH patients who haven't used complement inhibitors. It will compare how well each drug works and monitor safety over time.See study design
What are the potential side effects?
While specific side effects aren't listed here, both Crovalimab and Eculizumab can potentially cause reactions related to the immune system since they work by inhibiting parts of it that could lead to symptoms like fever, headache, nausea or infections.
COMMODORE 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants who achieve Transfusion Avoidance (TA)
Percentage of Participants with hemolysis control
Secondary outcome measures
Change in Free Hemoglobin and Haptoglobin (mg/dL)
Change in PD biomarkers including complement activity (CH50) over time
Change in Reticulocyte Count (count/mL)
+12 moreSide 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
COMMODORE 2 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (Crovalimab) (Exploratory)Experimental Treatment1 Intervention
Paediatric 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
Crovalimab will be administered at an initial loading dose of 1000 milligrams (mg) (for participants with body weight between 40 and 100 kg) or 1500 mg (for participants with body weight >=100kg), as intravenous (IV) injection on Day 1 of Week 1 followed by four weekly subcutaneous (SC) injections of 340 mg starting on Day 2 of Week 1 and then once weekly (QW) at Weeks 2,3 and 4. Thereafter crovalimab will be administered, as SC injection, at a maintenance dose of 680 mg (for participants with body weight between 40 and 100kg) or 1020 mg (for participants with body weight >=100kg) once every 4 weeks (Q4W) from Week 5 for a total of 24 weeks of study treatment. Participants may continue to receive crovalimab after 24 weeks of treatment up to maximum of 5 years.
Group III: Arm B (Eculizumab)Active Control1 Intervention
Participants will receive loading dose of eculizumab 600 mg on Days 1, 8, 15, and 22, followed by maintenance dose of 900 mg on Day 29 and every 2 weeks (Q2W) thereafter until 24 weeks. Participants may switch to receive crovalimab after 24 weeks of eculizumab treatment.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,850 Total Patients Enrolled
Chugai PharmaceuticalIndustry Sponsor
94 Previous Clinical Trials
21,356 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,298 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight is at least 40 kg.I have a history of or currently have cryoglobulinemia.I have been treated with a complement inhibitor.I had a Neisseria meningitidis infection in the last 6 months.I have had a bone marrow transplant from another person.My PNH diagnosis was confirmed with a specific blood test.I agree to use birth control or remain abstinent during and after treatment as required.My condition is a type of blood disorder with a moderate to very high risk score.I had my spleen removed less than 6 months ago.I have been vaccinated against meningitis (A, C, W, Y) within the last 3 years or will be within a week of starting the study.I haven't been in a drug study or taken experimental therapy in the last 28 days or 5 half-lives of the drug.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (Crovalimab)
- Group 2: Arm C (Crovalimab) (Exploratory)
- Group 3: Arm B (Eculizumab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Crovalimab been cleared by the FDA?
"Crovalimab has received a safety score of 3. This is because Crovalimab is in Phase 3 of clinical trials, meaning that there is some efficacy data as well as multiple rounds of safety data."
Answered by AI
Are there any other studies like this one that have been conducted previously?
"Since 2016, Crovalimab has been under medical scrutiny with the first study being sponsored by Hoffmann-La Roche. In 2016, 59 people were observed in the initial study which then led to Phase 1 & 2 drug approval. As of now, 20 active studies are being conducted in 144 different cities located in 43 countries."
Answered by AI
Could you please tell us what other research studies have been done using Crovalimab?
"Tokyo Medical University Hospital was the first to study crovalimab in 2016. There have been 43 completed studies on the drug since then, 20 of which are ongoing. The majority of these live studies are taking place in Charlotte, North carolina."
Answered by AI
What is the total number of patients enrolled in this research project?
"This study is not looking for new patients at the moment. The trial was first posted on October 8th, 2020 and was updated October 18th, 2020. For those 33 other clinical trials enrolling patients with paroxysmal nocturnal haemoglobinuria (pnh) and 20 trials for Crovalimab."
Answered by AI
What are some of the primary ways that Crovalimab is being used by doctors?
"Most commonly, crovalimab is used to treat myasthenia gravis. However, it can also be taken as medication for neuromyelitis optica, paroxysmal nocturnal haemoglobinuria (pnh), and thyroid stimulating immunoglobulins."
Answered by AI
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