RecruitingPhase 2NCT06298955
Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Sponsor
Omeros Corporation
Enrollment
25 participants
Start Date
Feb 19, 2024
Study Type
INTERVENTIONAL
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria6
- 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.
- Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study.
- Have provided informed consent
Exclusion Criteria7
- 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.
- Pregnant, planning to become pregnant, or nursing female patients.
- History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the long-term extension.
- Unable or unwilling to comply with the requirements of the study.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGOMS906 study drug
OMS906 study drug repeat-dose 5mg/kg IV administration at 8-week intervals
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06298955