Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

Launched by OMEROS CORPORATION · Mar 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the long-term safety and effectiveness of a treatment called OMS906 for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare blood condition. Participants will receive OMS906 through an intravenous (IV) infusion every eight weeks. The study aims to see how well patients tolerate the treatment and if it helps manage their PNH symptoms over time.

To be eligible for this trial, patients must have completed a previous study involving OMS906 and meet certain health criteria, such as having a stable platelet count and being current on specific vaccinations. Both men and women can participate, but women who can become pregnant need to take precautions to avoid pregnancy during the study and for some time afterward. Participants can expect regular visits for treatment and monitoring, and they will be closely observed for any side effects. Overall, this trial is a step toward understanding how OMS906 can help manage PNH in the long term.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have completed the last dosing visit of the prior OMS906 PNH study.
• • 2. Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906.
• • 3. 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.
• • 4. 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.
• • 5. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study.
• • 6. Have provided informed consent
• Exclusion Criteria:
• • 1. Platelet count \<30,000/µL or absolute neutrophil count \<500 cells/µL at the start of the Evaluation Period.
• • 2. 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.
• • 3. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.
• • 4. Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis.
• • 5. Pregnant, planning to become pregnant, or nursing female patients.
• • 6. 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.
• • 7. Unable or unwilling to comply with the requirements of the study.