Myelodysplastic Syndrome Clinical Trial
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
Summary
The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab. Patients will be treated with RA101495 for 12 weeks.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of PNH by flow cytometry
Inadequate response to eculizumab defined as having received eculizumab for at least 6 months plus a documented LDH level ≥ 1.5 x the upper limit of normal (ULN) and/or the presence of a known C5 mutation conferring resistance to eculizumab
Exclusion Criteria:
History of meningococcal disease
Current systemic infection or suspicion of active bacterial infection
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There are 6 Locations for this study
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Chicago Illinois, 60612, United States
Manhasset New York, 11030, United States
Durham North Carolina, 27710, United States
Dallas Texas, 75390, United States
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