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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
Willingness and ability to comply with all study visits and procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

COMMODORE 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight is at least 40 kg.
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I am willing and able to follow all study requirements.
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I agree to avoid pregnancy or use birth control during and after treatment.
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My PNH diagnosis was confirmed with a specific blood test.
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I have been treated with eculizumab or ravulizumab for PNH for at least 3 months.
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I have been vaccinated against meningitis within the last 3 years, or I can get vaccinated within a week after starting the study treatment.

COMMODORE 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 8 years for reporting.

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 with Adverse Events (AEs) Leading to Study Drug Discontinuation
Percentage of Participants with Adverse Events (AEs) and by Severity
Percentage of Participants with Clinical Manifestations of Drug-Target-Drug Complex (DTDC) Formation Amongst Those Participants who Switched to Crovalimab Treatment from Eculizumab Treatment or Ravulizumab Treatment
+1 more
Secondary outcome measures
Absolute Change in Free Hemoglobin and Haptoglobin (mg/dL)
Change Over Time in Free C5 Concentration in Crovalimab-Treated Participants
Change in Pharmacodynamic (PD) Biomarker Complement Activity (CH50) Over Time
+6 more

Side effects data

From 2020 Phase 3 trial • 36 Patients • NCT02013037
19%
Bacterial Infections
17%
Viral infections
6%
Fungal infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eculizumab

COMMODORE 1 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.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,088,961 Total Patients Enrolled
Chugai PharmaceuticalIndustry Sponsor
94 Previous Clinical Trials
21,329 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,401 Total Patients Enrolled

Media Library

Crovalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04432584 — Phase 3
Paroxysmal Nocturnal Hemoglobinuria Research Study Groups: Arm A (Crovalimab), Arm B (Eculizumab), Arm C (Crovalimab) (Exploratory)
Paroxysmal Nocturnal Hemoglobinuria Clinical Trial 2023: Crovalimab Highlights & Side Effects. Trial Name: NCT04432584 — Phase 3
Crovalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04432584 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~115 spots leftby Sep 2029