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ACTIVE NOT RECRUITINGPhase2

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

Sponsor: Omeros Corporation

NCT ID: NCT06298955

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
OMS906 study drug (drug)
How long the study runs
Study runs about 38 months (dates as stated)
About the drug or intervention
OMS906 study drug — drug: OMS906 study drug repeat-dose 5mg/kg IV administration at 8-week intervals
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 99 Years
Who
All
Number of participants
25
Started
2024-02-19
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for paroxysmal nocturnal hemoglobinuria
  • • Phase2 - 25 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 99 Years
  • • Diagnosed with paroxysmal nocturnal hemoglobinuria

Where?

  • • Leeds - Omeros Investigational Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a multicenter, open-label, single arm study. The primary objective is to assess the long-term safety and tolerability of OMS906 in patients with PNH. Secondary objectives of this study include assessment of the long-term efficacy of OMS906 in patients with PNH. Patients will receive OMS906 5 mg/kg administered as intravenous (IV) injections at 8-week intervals.

Paroxysmal Nocturnal Hemoglobinuria

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 99 Years
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ a negative result from a highly sensitive urine pregnancy test

What the study is looking for

  • ✓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...
  • ✓Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks...
  • ✓Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial...
  • ✓Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and...

Who cannot take part

  • ✗blood clotting cell count \<30,000/µL or infection-fighting white blood cell count \<500 cells/µL at the start of the Evaluation Period.
  • ✗History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906...
  • ✗Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae...
  • ✗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...
See the full 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 Is This Study? (1 UK site)

Omeros Investigational Site

Leeds, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-07