CompletedPhase 1

Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Ukraine15 participantsStarted 2022-12-09

Plain-language summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Confirmed diagnosis of PNH by flow cytometry with PNH clone size of \>10% RBCs and/or granulocytes.
✓. Male or female adults 18 years and older.
✓. Competent to provide consent and completed informed consent procedures.
✓. Patients who are not receiving complement inhibitor treatment or, alternatively, patients currently treated with eculizumab or ravulizumab with an inadequate response to treatment defined as a Hgb \<10.5 g/dL. Patients receiving eculizumab or ravulizumab must be on stable doses for at least 6 months.
✓. Hemoglobin level \<10.5 g/dL at screening and baseline.
✓. Lactate dehydrogenase \>1.5 upper limit of normal (ULN) for patients not receiving eculizumab or ravulizumab.
✓. Female patients of child-bearing potential (CBP) must have a negative serum test at screening and 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 (140 days) following their last dose of study drug.

Exclusion criteria

✕. Treatment with any complement pathway inhibitor except eculizumab or ravulizumab within the 6 months prior to screening.
✕. For patients not receiving eculizumab or ravulizumab at the time of screening: receipt of eculizumab within 8 weeks prior to screening or receipt of ravulizumab within 24 weeks prior to screening.
✕. History of major organ transplant or hematopoietic stem cell/bone marrow transplant.
✕. Reticulocyte count \<100,000 /µL, transfusion-free platelet count \<30,000/µL or absolute neutrophil count \<500 cells/µL at screening.
✕. Anemia attributable to any other medical condition apart from PNH.
✕. Elevation of liver function tests, defined as total bilirubin \>2×ULN, direct bilirubin \>1.5xULN, and elevated transaminases, alanine aminotransaminase (ALT) or aspartate transaminase (AST), \>2×ULN unless due to PNH related hemolysis.
✕. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.
✕. Significant active bacterial, fungal, or viral infection within the 2 weeks of OMS906 drug initiation, including COVID-19 infection.

What they're measuring

To Assess the Overall Safety and Tolerability of Zaltenibart (OMS906) Administration in PNH patients

Timeframe: 48 weeks

Trial details

NCT IDNCT05889299

SponsorOmeros Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-03

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