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A study to evaluate the safety and how the body uses ublituximab injections in patients with multiple sclerosis

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
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What is this trial about?

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

This study focuses on Multiple Sclerosis, a condition that affects the central nervous system. The research aims to evaluate the pharmacokinetics, which describes how a drug moves through the body, and the safety of ublituximab. This medication is administered via subcutaneous injection, meaning it is delivered through a needle into the fatty tissue just under the skin.

The investigation is divided into two parts to compare different ways of giving the medication. One part looks at using different areas of the body for the injection, while the other part compares using an autoinjector, a device designed to deliver the medicine automatically, against a standard syringe. This comparison helps to determine the relative bioavailability, which refers to how much of the drug actually enters the bloodstream when using one method versus another.

The research process

The trial runs in 1 step.

Step 1
Administration of medication
A subcutaneous injection, which is an injection given just under the skin, of 400 mg of ublituximab is administered.
The medication is provided as a solution for injection and is delivered using either an autoinjector device (a pre-set device that automatically injects the medicine) or a syringe.

Who can join the trial?

7 criteria

You must be between 18 and 65 years old.
You must have been diagnosed with relapsing multiple sclerosis, which is a type of multiple sclerosis where symptoms appear and then go away.
You must have medical records showing you had either two or more relapses (periods where new or worsening symptoms appear) in the last 2 years, or one relapse in the last year.
Alternatively, you must have had at least one Gd enhancing lesion in the last year, which is an area of inflammation seen on an MRI scan.
Your Expanded Disability Status Scale (EDSS) score must be 5.5 or lower. The EDSS is a scale used by doctors to measure how much disability a person has due to their condition.
Your neurological condition must have been stable, meaning your symptoms have not changed significantly, for more than 30 days before starting the study.
Women who are able to become pregnant must agree to use an effective method of contraception (birth control) from the start of the study until 6 months after the final dose of the study medication.

Who cannot join the trial?

15 criteria

You have Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS), which are specific types of multiple sclerosis that involve a steady worsening of symptoms over time.
You have a history or evidence of progressive multifocal leukoencephalopathy (PML), which is a rare and serious brain infection caused by a virus.
You have received any live vaccines, such as those for measles or varicella-zoster (chickenpox), within 4 weeks before starting the study drug.
You have any severe or uncontrolled medical condition that might prevent you from safely taking part in the study.
You are pregnant or nursing (breastfeeding).
You have a history of malignancy, which is another word for cancer, unless it was a specific type of skin cancer that has been completely treated.
You are unable or unwilling to follow the rules and procedures of the study.
You have an active or stable immune system disease other than multiple sclerosis, such as rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn’s disease, or ulcerative colitis, or a condition where your immune system (the body's defense against germs) does not work properly.
Your organ function, such as how well your liver or kidneys work, is significantly impaired according to laboratory tests.
You have taken any investigational agent, which is an experimental medicine, within a certain timeframe (5 half-lives, which refers to the time it takes for half of a drug to leave your body) before the study starts.
You have a history of life-threatening reactions, such as anaphylaxis (a severe, sudden allergic reaction), to ublituximab, the study medication, or the medications or MRI contrast (the dye used during brain scans) required for the study.
You have an active infection or a history of frequent, significant infections.
You have a history of opportunistic infections, which are infections that happen more easily in people with weakened immune systems, such as HIV or tuberculosis.
You have a history of hepatitis B, which is a liver infection, confirmed by specific blood tests.
You have a chronic hepatitis C infection, unless a specific blood test called a PCR shows that the virus is not active in your body.

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Verified sites

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

Verified & featuredResponsive
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Recruiting
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Centrum Neurologii Krzysztof Selmaj
Lodz, Poland
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Wojewodzki Szpital Specjalistyczny W Olsztynie
Olsztyn, Poland

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Investigated drugs

Ublituximab is a medication given as a shot under the skin. It is being studied to see how well the body absorbs the medicine when it is injected using different methods, such as an automatic injector device or a regular syringe, in people living with multiple sclerosis.

Ublituximab

What is already known about the treatment

Ublituximab - This medication is an injection given under the skin to treat multiple sclerosis. It is currently being studied in clinical trials to better understand how it is absorbed and how safe it is when using different delivery methods. This drug belongs to a group of medicines called monoclonal antibodies, which work by attaching to specific proteins on the surface of immune cells. By targeting these cells, the medication helps to reduce the activity of the immune system that causes nerve damage in people with this condition.

Investigated diseases

Multiple sclerosis - This is a condition where the body's immune system attacks the protective covering that surrounds nerve cells. This damage disrupts the communication signals between the brain and the rest of the body. Over time, this process can lead to the formation of scar tissue in the nervous system. The disease often progresses through different stages, involving periods of new symptoms followed by periods of stability. As the condition advances, the nerve damage can become more widespread throughout the central nervous system.