(COMMODORE 1) A Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab ... | Aplastic Anemia & MDS International Foundation

ClinicalTrials.gov Identifier:

NCT04432584

Contact Info


(888) 662-6728

Hours: Monday - Friday, 5am - 5pm PT

Dates

Start: September 2020
End: October 2024

Official Title

(COMMODORE 1) A Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Adult And Adolescent Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Purpose

The purpose of the study is to evaluate the efficacy and safety of crovalimab compared with eculizumab in adult and adolescent participants with Paroxysmal Nocturnal Hemoglobinuria (PNH) treated with complement inhibitors. This clinical trial is recruiting people with a diagnosis of PNH, a blood disorder that involves the breakdown of red blood cells, and that receive treatment with eculizumab or ravulizumab before starting the clinical trial. This study will enroll approximately 250 participants around the globe and will assign participants into two different groups receiving Crovalimab or Eculizumab.

(COMMODORE 1) A Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Adult And Adolescent Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Clinical Trial: NCT04432584

Other Study ID:
BO42161
Status: 
Recruiting
Associated Drug(s): 
Phase: 
Phase 3
Gender: 
Female
Male
Age Group: 
12 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
Body weight >= 40 kg at screening. Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1. Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening. Willingness and ability to comply with all study visits and procedures. Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry. Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment. Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 6 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab.
Exclusion Criteria: 
History of allogeneic bone marrow transplantation. Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the final dose of study treatment. Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their current trial. Positive for Active Hepatitis B and C infection (HBV/HCV). Concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study. History of or ongoing cryoglobulinemia at screening.

Find Out More:

Instructions:

If you are interested in learning more about your possible participation in this clinical trial, please contact Genentech directly at (888) 662-6728 (Monday - Friday, 5am - 5pm PT).

Disclaimer

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