Not recruitingRare disease

Study on the Long-Term Safety and Effects of OMS906 for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a rare blood disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH is a condition where red blood cells break down too early, leading to various health issues. The study will use a treatment known as OMS906, which is given as a solution for injection. The purpose of the study is to evaluate the long-term safety and how well patients tolerate this treatment when it is administered every eight weeks.

Participants in the study will receive OMS906 through an intravenous injection, which means it will be delivered directly into a vein. The study will last for a period of up to two years, during which the effects of the treatment will be closely monitored. This includes checking for any side effects and assessing the overall health of the participants. The study aims to understand how safe the treatment is over a long period and how well it works in managing the symptoms of PNH.

Throughout the study, participants will have regular check-ups to monitor their health, including tests to measure their blood levels and other important health indicators. The study will also look at how the treatment affects the need for blood transfusions and whether it helps maintain healthy blood levels. By the end of the study, researchers hope to gather valuable information about the long-term use of OMS906 in treating PNH.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure completion of the last dosing visit from previous OMS906 studies. Eligibility requires a good response and tolerance to OMS906.
Female participants must undergo a urine pregnancy test before each dose of OMS906 to confirm a negative result.
Step 2
Initial preparations
Ensure current vaccinations for Neisseria meningitidis, Streptococcus pneumonia, and Haemophilus influenzae, maintaining them throughout the study.
Step 3
Medication administration
Receive OMS906 as a solution for injection through intravenous use. The dosage is 5 mg per kg of body weight.
The medication is administered every 8 weeks.
Step 4
Ongoing monitoring
Regular assessments will be conducted to monitor safety and tolerability. This includes checking for adverse events, vital signs, electrocardiograms (ECGs), and clinical laboratory tests.
Step 5
Efficacy evaluation
Efficacy is evaluated by measuring the proportion of patients achieving hemoglobin levels of at least 12.0 g/dL at 6-month intervals.
Other measures include maintaining an increase in hemoglobin of at least 2 g/dL, being transfusion-free at Weeks 48 and 96, and monitoring for clinical breakthrough hemolysis at these intervals.
Step 6
Study duration
The study is expected to continue until December 31, 2026.

Who can join the trial?

6 criteria

Must have completed the last dosing visit of previous OMS906 studies for Paroxysmal Nocturnal Hemoglobinuria (PNH). Patients should have tolerated the treatment well and shown a good clinical response.
Female patients who can have children must have a negative result from a very sensitive urine pregnancy test before each dose of the study drug.
Females must use highly effective birth control methods to prevent pregnancy during the study and for 20 weeks (140 days) after the last dose. This includes options like hormonal birth control, intrauterine devices, or having a partner who is surgically sterile. Abstinence is also acceptable if it aligns with the patient's lifestyle.
Males must use highly effective birth control with a female partner to prevent pregnancy during the study and for 20 weeks (140 days) after the last dose. This can include abstinence or using effective contraception methods.
Must have up-to-date vaccinations for certain bacteria: Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae. Patients must agree to keep these vaccinations current throughout the study.
Must have provided informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have received another investigational drug within the last 30 days.
Patients who have a history of allergic reactions to similar medications.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures.
Patients who have a history of certain blood disorders.
Patients who have had a recent blood transfusion.
Patients who have a history of cancer within the last 5 years.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
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Universitaetsklinikum Aachen AöR
Aachen, Germany

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Investigated drugs

OMS906 is a medication being studied for its long-term safety, tolerability, and effectiveness in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). It is administered through an intravenous infusion every eight weeks. The study aims to understand how well patients tolerate repeated doses of this medication over an extended period.

Oms906

What is already known about the treatment

OMS906 – This medication is administered intravenously, with a dosage of 5 mg/kg given every eight weeks. It is currently being studied in clinical trials to evaluate its long-term safety, tolerability, and effectiveness for treating Paroxysmal Nocturnal Hemoglobinuria (PNH). The main therapeutic indication for OMS906 is PNH, a rare blood disorder. At the molecular level, OMS906 works by targeting specific pathways involved in the disease process, although the exact mechanism is still under investigation. It is classified pharmacologically as a monoclonal antibody, which is a type of protein designed to interact with specific targets in the body.

Investigated diseases

Paroxysmal Nocturnal Hemoglobinuria (PNH) – Paroxysmal Nocturnal Hemoglobinuria is a rare blood disorder characterized by the destruction of red blood cells, leading to hemoglobin release into the urine. This condition is caused by a mutation in the PIGA gene, affecting the surface proteins that protect red blood cells from the immune system. Patients may experience symptoms such as fatigue, shortness of breath, and dark-colored urine, especially in the morning. Over time, the destruction of red blood cells can lead to anemia and other complications. The disease can also cause blood clots, which may lead to further health issues. PNH is a chronic condition that requires ongoing management to address its symptoms and complications.