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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (1 UK site)
Omeros Investigational Site
Leeds, United Kingdom
