A Phase 2 interventional study of OMS906 study drug in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Omeros Corporation. Active, not recruiting at 5 sites in 4 countries. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Omeros Corporation · Phase 2, Interventional, and Treatment
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.
This is a multicenter, open-label, single arm study. The primary objective is to assess the long-term safety and tolerability of OMS906 in patients with PNH. Secondary objectives of this study include assessment of the long-term efficacy of OMS906 in patients with PNH. Patients will receive OMS906 5 mg/kg administered as intravenous (IV) injections at 8-week intervals.
188 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 48 are open to participants now.
This study's planned enrollment of 25 is below the median of 34 across 147 interventional studies indexed under Hemoglobinuria, Paroxysmal.
Browse Hemoglobinuria, Paroxysmal studies →Omeros Corporation is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OMS906 study drug repeat-dose 5 mg/kg IV administration at 8-week intervals.
Drug: OMS906 study drug
OMS906 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.
Time frame: 104 weeks
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.
Time frame: 6 month intervals
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.
Time frame: Weeks 48 and 96
To assess efficacy by measurement of lactate dehydrogenase (LDH).
Measure mean LDH change from baseline.
Time frame: Weeks 48 and 96
To assess efficacy by measurement of reticulocyte count.
Measure mean change in reticulocyte count from baseline.
Time frame: Weeks 48 and 96
To assess efficacy by measurement of clinical breakthrough hemolysis.
Measure proportion of patients experiencing clinical breakthrough hemolysis.
Time frame: Weeks 48 and 96
To assess population PK Cmax of OMS906.
Pharmacokinetics (PK) of multiple-dose administration of OMS906 using PK parameter maximum concentration (Cmax).
Time frame: Weeks 48 and 96
To assess population PK AUC of OMS906.
Pharmacokinetics (PK) of multiple-dose administration of OMS906 using PK parameter area under the time-concentration curve (AUC).
Time frame: Weeks 48 and 96
To assess population PK terminal half life of OMS906.
Pharmacokinetics (PK) of multiple-dose administration of OMS906 using terminal half-life parameter.
Time frame: Weeks 48 and 96
To assess PD of OMS906
PD parameters include change from baseline in mature complement factor D (FD).
Time frame: Weeks 48 and 96
OMS906 anti-drug antibodies (ADA).
Presence of ADA in serum will be measured.
Time frame: Weeks 24, 48, 72, and 96
Assess the change in Functional Assessment of Chronic Illness Therapy (FACIT) fatigue score.
To assess the effect of OMS906 on Quality of Life using the FACIT fatigue scale.
Time frame: Weeks 24, 48, 72, and 96
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Omeros Corporation