Actively Recruiting
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Led by Omeros Corporation · Updated on 2024-03-07
25
Participants Needed
5
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and tolerability of OMS906 in people with Paroxysmal Nocturnal Hemoglobinuria (PNH). This open-label, single-arm study aims to assess how well patients tolerate repeated doses of OMS906 given every 8 weeks and to observe the drug's long-term effects. The study is sponsored by Omeros Corporation and focuses on patients who have completed a prior OMS906 study. Participants receive OMS906 at a dose of 5 mg per kilogram through intravenous injection every 8 weeks. This phase 2 study involves ongoing treatment with this repeat-dose regimen to monitor safety and efficacy over time. The study does not include a placebo group, and all participants receive the active drug. During the study, patients will have regular safety assessments for up to 104 weeks, including laboratory tests to monitor blood counts and liver function. Researchers will also measure efficacy outcomes such as hemoglobin levels, transfusion needs, lactate dehydrogenase, reticulocyte count, and breakthrough hemolysis at specific intervals. Additional evaluations include pharmacokinetics and anti-drug antibody levels, as well as fatigue scores. Participants are monitored closely for any side effects or complications throughout the study period.
CONDITIONS
Brief Title
Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have completed the last dosing visit of the prior OMS906 PNH study.
- Female patients of childbearing potential must have a negative urine pregnancy test before each OMS906 dose.
- Females must use highly effective birth control during the trial and for 20 weeks after the last dose.
- Males must use highly effective birth control with a female partner during the trial and for 20 weeks after last dose.
- Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia, and Hemophilus influenza and agree to maintain vaccination throughout the study.
- Have provided informed consent.
You will not qualify if you...
- Platelet count less than 30,000/µL or absolute neutrophil count less than 500 cells/µL at study start.
- Elevated liver function tests above defined limits unless due to PNH-related hemolysis.
- History of severe hypersensitivity to monoclonal antibodies or OMS906 components.
- Unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae, or N. meningitidis.
- Pregnant, planning to become pregnant, or nursing females.
- Significant medical, neurological, or psychiatric disorders making participation unsuitable.
- Unable or unwilling to comply with study requirements.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 104 weeks
Participants receive OMS906 study drug as intravenous injections at 8-week intervals to assess long-term safety, tolerability, and efficacy.
Visits every 8 weeks for OMS906 intravenous administration
Duration - 20 weeks after last dose
Participants are monitored for safety and efficacy outcomes after treatment ends.
Visits as needed for safety monitoring during follow-up period
Trial Site Locations
Total: 5 locations
1
Omeros Investigational Site
Aachen, Germany
Not Yet Recruiting
2
Omeros Investigational Site
Ulm, Germany
Not Yet Recruiting
3
Omeros Investigational Site
Lausanne, Switzerland
Actively Recruiting
4
Omeros Investigational Site
Kyiv, Ukraine
Not Yet Recruiting
5
Omeros Investigational Site
Leeds, United Kingdom
Not Yet Recruiting
Research Team
O
Omeros Clinical Trial Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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