Long-term treatment with OMS906 for patients with 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)

This study is testing a new treatment called OMS906 to see if it is safe and effective for people with Paroxysmal Nocturnal Hemoglobinuria over a long period of time.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Omeros Corporation (Industry-sponsored)
• Locations: 5 sites (Aachen and 4 other locations)
• Trial ID: NCT06298955 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the long-term safety, tolerability, and efficacy of OMS906, administered intravenously at a dose of 5 mg/kg every 8 weeks, in patients diagnosed with Paroxysmal Nocturnal Hemoglobinuria (PNH). It is a multicenter, open-label, single-arm study that aims to gather data on how well the treatment works over an extended period. Participants will be monitored for any adverse effects and overall treatment effectiveness throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have previously participated in an OMS906 PNH study and meet specific health criteria.

Not a fit: Patients with severely low platelet or neutrophil counts, or significant liver function test elevations, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new long-term management option for patients suffering from PNH.

How similar studies have performed: Other studies involving similar treatments for PNH have shown promising results, indicating potential for success in this approach.

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.

Where this trial is running

Aachen and 4 other locations

• Omeros Investigational Site — Aachen, Germany (Not_yet_recruiting)
• Omeros Investigational Site — Ulm, Germany (Not_yet_recruiting)
• Omeros Investigational Site — Lausanne, Switzerland (Recruiting)
• Omeros Investigational Site — Kyiv, Ukraine (Not_yet_recruiting)
• Omeros Investigational Site — Leeds, United Kingdom (Not_yet_recruiting)

Study contacts

• Study coordinator: Omeros Clinical Trial Information

Conditions Paroxysmal Nocturnal Hemoglobinuria; PNH