A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With P… (NCT04434092) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors
A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.
Who can participate
Age range2 Years
SexALL
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Inclusion Criteria:
* Body weight ≥ 40 kg at screening (pediatric participants with body weight \< 40 kg)
* Willingness and ability to comply with all study visits and procedures
* Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry
* LDH level ≥ 2x ULN at screening (as per local assessment)
* 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 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 Criteria:
* Current or previous treatment with a complement inhibitor
* History of allogeneic bone marrow transplantation
* History of Neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration
* 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 in…
What they're measuring
1
Percentage of Participants With Transfusion Avoidance (TA)
Timeframe: Baseline to Week 25
2
Percentage of Participants With Hemolysis Control Measured by LDH