Status:
ACTIVE_NOT_RECRUITING
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Chugai Pharmaceutical
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.
Eligibility Criteria
Inclusion
- Body weight ≥ 40 kg at screening (pediatric participants with body weight \< 40 kg)
- 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 serotypes A, C, W, and Y \< 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration
- Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label)
Exclusion
- History of allogeneic bone marrow transplantation
- History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high
- Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label)
- 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 participation in current trial before randomisation/enrolment
- 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
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04432584
Start Date
September 30 2020
End Date
September 30 2027
Last Update
October 30 2025
Active Locations (83)
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1
Carolinas Healthcare System
Charlotte, North Carolina, United States, 28204
2
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
3
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
4
AZ Delta Campus Westlaan
Roeselare, Belgium, 8800