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Clinical Trials in the UK / NCT06298955
Active, not recruiting Phase 2

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

NCT06298955 · tracked via the Priya Life Science UK tracker
Sponsor
Omeros Corporation
Phase
Phase 2
Started
2024-02-19
Last updated
2026-07-16

Condition(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Investigational drug(s) / intervention(s)

OMS906 study drug

OMS906 study drug: OMS906 study drug repeat-dose 5mg/kg IV administration at 8-week intervals

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Omeros Investigational Site Aachen Germany
Omeros Investigational Site Ulm Germany
Omeros Investigational Site Lausanne Switzerland
Omeros Investigational Site Kyiv Ukraine
Omeros Investigational Site Leeds United Kingdom

More Omeros Corporation trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06298955 on ClinicalTrials.gov ↗ ← All trials in the UK