Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria (NCT05889299) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Assess the Overall Safety and Tolerability of Zaltenibart (OMS906) Administration in PNH patients
. 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.