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Study on the Effectiveness of Ublituximab and Drug Combination for Patients with Relapsing 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 clinical trial is focused on studying the effectiveness of a modified treatment regimen for relapsing multiple sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The treatment being tested is called ublituximab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins designed to target specific cells in the body. In this study, ublituximab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well this modified regimen of ublituximab works in reducing certain types of brain lesions, which are areas of damage in the brain that can be seen using a special imaging technique called MRI (magnetic resonance imaging). Participants in the study will receive the treatment over a period of 48 weeks, and the main goal is to see if there is no change or a reduction in the number of these lesions from the start of the study to the end. The study will also look at other aspects, such as the overall satisfaction of participants with the treatment and any side effects they may experience.

In addition to ublituximab, other medications like cetirizine, dexamethasone, methylprednisolone, paracetamol, diphenhydramine, and gadobutrol may be used during the study. These medications are commonly used to manage symptoms or as part of the treatment process. The study aims to provide valuable information on the effectiveness and safety of ublituximab for people with relapsing multiple sclerosis, potentially leading to improved treatment options in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of relapsing multiple sclerosis, and other health criteria.
Participants must be between 18 and 65 years old and have a specific score on a disability scale. Women of childbearing potential must agree to use contraception.
Step 2
Baseline evaluation
A baseline evaluation is performed to measure the number of T1 Gd-enhancing lesions using imaging techniques. This serves as a reference point for future assessments.
Step 3
Medication administration
The main medication, ublituximab, is administered through an intravenous infusion. The schedule and dosage are determined by the study protocol.
Additional medications may include cetirizine, dexamethasone, methylprednisolone, paracetamol, and diphenhydramine, which are taken orally or by injection as needed to manage symptoms or side effects.
Step 4
Ongoing monitoring
Participants are monitored regularly to assess the effectiveness of the treatment and any side effects. This includes periodic imaging to check for changes in T1 Gd-enhancing lesions.
Regular check-ups are scheduled to ensure participant safety and to adjust treatment as necessary.
Step 5
Mid-study evaluation
At Week 24, a mid-study evaluation is conducted. This includes a questionnaire to assess treatment satisfaction and further imaging to monitor lesion changes.
Step 6
Final evaluation
At Week 48, a final evaluation is performed. The primary goal is to determine if there has been no change or a reduction in the number of T1 Gd-enhancing lesions.
Secondary assessments include the absence of lesions, any infusion-related reactions, and overall treatment satisfaction.
Step 7
Study completion
Upon completion of the study, participants may undergo a final health assessment. The study's findings will contribute to understanding the efficacy of the modified ublituximab regimen.

Who can join the trial?

8 criteria

Age between 18 and 65 years old.
Have a diagnosis of **relapsing multiple sclerosis** (RMS) according to the 2017 Revised McDonald criteria. This is a set of guidelines used to diagnose multiple sclerosis, a condition that affects the brain and spinal cord.
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Must meet one of the following treatment conditions:
- Never received treatment for RMS before.
- Previously treated with a **disease-modifying therapy** (DMT) but stopped treatment before joining the study and meet specific waiting period requirements.
- Have an **EDSS score** of 5.5 or less at screening. The EDSS, or Expanded Disability Status Scale, is a method of measuring disability in people with multiple sclerosis.
- Be neurologically stable before receiving the first dose of **ublituximab**. This means that there should be no recent changes in neurological symptoms.
- Female participants who can have children must agree to use a medically approved method of birth control from the time they join the study, throughout the study, and for a specified time after the last dose of ublituximab.
- Have **IgG** and **absolute lymphocyte count** at the required levels during screening. IgG is a type of antibody, and lymphocytes are a type of white blood cell important for the immune system.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with **relapsing multiple sclerosis** cannot participate. This is a type of multiple sclerosis where symptoms come and go.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
Patients who do not meet other specific health criteria set by the study may be excluded. These criteria are usually related to the patient's overall health and medical history.

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Verified sites

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
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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 being studied for its effectiveness in treating certain medical conditions. It is a type of therapy that targets specific cells in the immune system. The goal of using ublituximab in this trial is to see how well it works in reducing certain types of lesions in the body. This medication is being tested to understand its potential benefits and how it might help patients with their condition.

What is already known about the treatment

Ublituximab – Ublituximab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating relapsing multiple sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves. The medication works by targeting a specific protein on the surface of certain immune cells, leading to their destruction and reducing inflammation. Ublituximab is classified as a monoclonal antibody, a type of drug designed to interact with specific targets in the body.

Investigated diseases

Relapsing Multiple Sclerosis – This is a chronic disease affecting the central nervous system, characterized by episodes of new or increasing neurological symptoms. These episodes, known as relapses, are followed by periods of partial or complete recovery. The disease can cause a wide range of symptoms, including fatigue, vision problems, and difficulties with coordination and balance. Over time, relapses may lead to a gradual worsening of symptoms. The exact cause of relapsing multiple sclerosis is unknown, but it involves an abnormal immune response that damages the protective covering of nerve fibers. The progression and severity of symptoms can vary greatly among individuals.