The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.
Have completed the last dosing visit of the prior OMS906 PNH study.
Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906.
Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug.
Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug.
Platelet count <30,000/µL or absolute neutrophil count <500 cells/µL at the start of the Evaluation Period.
Elevation of liver function tests, defined as total bilirubin > 2 x ULN, direct bilirubin > 1.5 x ULN, and elevated transaminases (alanine or aspartate aminotransferase), > 2 X ULN unless due to PNH-related hemolysis.
History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.
Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis.
Single group
OMS906 study drug
DrugOMS906 study drug repeat-dose 5mg/kg IV administration at 8-week intervals
To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients.
Treatment-emergent adverse events, including clinically significant clinical laboratory tests, 12-lead electrocardiograms, vital signs, and physical examinations recorded as an adverse event.
To assess efficacy measured by hemoglobin (Hgb).
Measured by patients achieving Hb ≥ 12.0 g/dL and by proportion of patients maintaining an increase in Hb ≥ 2 g/dL, achieved in the prior study, through the duration of the long-term extension.
To assess efficacy by transfusion requirements.
Measure proportion of patients who are transfusion free and mean change from baseline in transfusion frequency from the start of the long-term extension.
To assess efficacy by measurement of lactate dehydrogenase (LDH).
Measure mean LDH change from baseline.
To assess efficacy by measurement of reticulocyte count.
Measure mean change in reticulocyte count from baseline.
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