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Study of ublituximab compared to fingolimod for children and teenagers aged 10 to 17 years with relapsing multiple sclerosis

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study involves children and teenagers with Relapsing Multiple Sclerosis, which is a condition where the immune system mistakenly attacks the protective covering of nerve fibers in the brain and spinal cord, causing symptoms that come and go in episodes. The study will test a medicine called ublituximab, which is also known by its code name TG-1101. This medicine is designed to target specific immune cells in the body. The study will also compare ublituximab with another medicine called fingolimod, which is already used to treat this condition. Some participants will receive placebo instead of the active medicines during certain parts of the study.

The purpose of the study is to understand how ublituximab works in young people with this condition, to see if it works as well as fingolimod, and to check its safety over a long period of time. The study is divided into three parts. In the first part, researchers will examine how the body processes ublituximab and how it affects certain immune cells in participants aged 10 to under 18 years. In the second part, the study will compare how well ublituximab works against fingolimod in controlling the disease. In the third part, participants who completed earlier parts of the study can continue to receive ublituximab to help researchers learn about its long-term safety and effectiveness.

During the study, ublituximab will be given through an intravenous infusion, which means it will be delivered directly into a vein, while fingolimod is taken by mouth as a capsule. Participants will have regular check-ups where doctors will monitor their condition, perform brain scans using MRI (a type of imaging that creates detailed pictures of the brain), check blood cell counts, and watch for any side effects. The study will track whether participants experience relapses, which are periods when symptoms get worse, and will measure changes in brain lesions, which are areas of damage that can be seen on brain scans. Throughout the study, the medical team will carefully monitor each participant's safety and response to treatment.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period begins
At the start of the study, your treatment assignment will be determined. This study has three parts: Part A, Part B, and Part C.
In Part A, you will receive ublituximab administered through intravenous infusion, which means the medication will be given directly into your vein through a tube. This part lasts for 24 weeks.
In Part B, you may receive either ublituximab through intravenous infusion or fingolimod taken by mouth, or you may receive a placebo version of either medication. A placebo looks like the real medication but contains no active ingredient. This part lasts for 96 weeks.
Your treatment assignment will depend on which part of the study you enter and will be determined by the study protocol.
Step 2
Receiving ublituximab treatment
If you are assigned to receive ublituximab, the medication will be given through intravenous infusion. This means a healthcare professional will insert a small tube into a vein in your arm, and the medication will slowly flow into your bloodstream.
The infusion will take place at scheduled visits to the study site.
The frequency and timing of these infusions will be determined according to the study protocol.
Step 3
Receiving fingolimod treatment
If you are assigned to receive fingolimod, you will take this medication by mouth as a capsule or tablet.
You will take fingolimod according to the dosing schedule provided to you.
This medication is taken orally, which means you swallow it with water.
Step 4
Regular monitoring visits
Throughout the study, you will attend regular visits at the study site for monitoring and assessments.
During these visits, your B cell count will be checked. B cells are a type of white blood cell that is part of your immune system. The medication affects these cells, so they need to be monitored.
Blood samples will be taken to measure the amount of medication in your bloodstream and to check for anti-drug antibodies. These are proteins your body might make in response to the medication.
Your Expanded Disability Status Scale score will be assessed. This is a way to measure how multiple sclerosis affects your physical abilities.
You will be asked questions using the Columbia-Suicide Severity Rating Scale, which helps assess your emotional well-being.
Step 5
Safety assessments
At each visit, you will be asked about any adverse events, which are any unwanted or unexpected symptoms or health problems that occur during the study.
The severity of any adverse events will be assessed using a standardized scale called the NCI CTCAE v5.0.
If you are female and able to become pregnant, you will need to have pregnancy tests during the study.
Your overall health and any changes in your condition will be monitored throughout the study period.
Step 6
Completion of Part A or Part B
If you are in Part A, this portion of the study will be completed at the Week 24 visit.
If you are in Part B, this portion of the study will be completed at the Week 96 visit.
After completing Part A or Part B, you may be eligible to continue into Part C of the study.
Step 7
Entry into Part C for long-term follow-up
If you have completed Part A at Week 24 or Part B at Week 96, you may be eligible to enter Part C of the study.
Part C is designed to evaluate the long-term safety and effectiveness of ublituximab in pediatric participants with relapsing forms of multiple sclerosis.
In Part C, you will continue to receive ublituximab treatment and will be monitored over an extended period.
Step 8
Ongoing monitoring in Part C
During Part C, you will continue to attend regular monitoring visits.
The same types of assessments will continue, including monitoring for adverse events, checking B cell counts, and evaluating the effectiveness of the treatment.
Your emotional well-being will continue to be assessed using the Columbia-Suicide Severity Rating Scale.
Part C will continue for an extended period to gather information about the long-term effects of the treatment.
Step 9
End of treatment and follow-up period
After you receive your last dose of medication, there will be a follow-up period.
If you received ublituximab or its placebo, the follow-up period will last for 20 weeks after your last dose.
If you received fingolimod or its placebo, the follow-up period will last for 8 weeks after your last dose.
If you received both types of medication at different times, the follow-up period will be whichever is longer.
During this time, certain safety assessments may continue, and if you are female and able to become pregnant, or if you are male and sexually active with women who can become pregnant, you will need to continue using contraception during this follow-up period.

Who can join the trial?

12 criteria

You must be at least 10 years old but younger than 18 years old (you have not yet had your 18th birthday)
You must have a diagnosis of Relapsing Multiple Sclerosis, which is a condition where symptoms come and go in episodes
You must meet one of these disease activity requirements: you had at least one relapse (a period when symptoms got worse) in the past 12 months, or you had at least two relapses in the past 24 months with at least one special type of brain scan finding, or you have new changes on your brain scan compared to a previous scan done within 12 months
You must have completed all the vaccinations recommended in your area and show proof of immunity to certain diseases including chickenpox, mumps, measles, rubella, diphtheria, tetanus, and whooping cough
Your EDSS score must be between 0 and 5.5. The EDSS is a scale that measures how much the disease affects your physical abilities, with lower numbers meaning less disability
Your B cell count must be within a certain range. B cells are a type of white blood cell in your immune system
Your neurological condition must be stable (not changing) for at least 30 days before starting the study
You must be willing and able to follow all study procedures and attend follow-up visits
If you are female and able to become pregnant, you must have a negative pregnancy test before starting treatment
If you are female and able to become pregnant, you must agree to use an acceptable form of birth control during the study and for 20 weeks after the last dose of the injection medicine or 8 weeks after the last dose of the pill medicine, whichever is later
If you are male and sexually active with females who can become pregnant, you must agree to use a condom during treatment and for 20 weeks after the last dose of the injection medicine or 8 weeks after the last dose of the pill medicine, whichever is later
Your parent or legal guardian must provide written permission for you to participate, and you must also agree to participate in a way that is appropriate for your age

Who cannot join the trial?

4 criteria

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why a patient cannot participate are not available in this document
Generally, clinical trials have exclusion criteria to ensure patient safety and accurate study results
Common reasons patients might not be able to join studies for multiple sclerosis (a condition where the body's defense system attacks the protective covering of nerves) include having other serious health conditions, taking certain medications that could interfere with the study drug, or having allergies to the study medication
If you are interested in this study, you would need to speak with the study doctors to learn the specific reasons that might prevent participation

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Verified sites

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

Verified
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Verified
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
Rzeszow, Poland
Verified
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, Poland

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Investigated drugs

Ublituximab
is a medicine being tested to treat relapsing forms of multiple sclerosis in children and teenagers. It is given to help control the symptoms of this condition by targeting certain cells in the immune system that may be causing the disease to progress.
Fingolimod
is a medicine that is already used to treat relapsing forms of multiple sclerosis. In this study, it is being used as a comparison treatment to see how well ublituximab works. Fingolimod works by keeping certain immune cells inside the lymph nodes so they cannot reach the brain and spinal cord where they might cause damage.

What is already known about the treatment

Ublituximab – Ublituximab is a medication given through an intravenous infusion (directly into a vein) that is being studied for treating relapsing forms of multiple sclerosis in children and teenagers aged 10 to 18 years. This drug is a type of antibody therapy that works by targeting and removing specific immune cells called B-cells, which are believed to play a role in causing damage to the protective covering of nerves in multiple sclerosis. It belongs to a class of medications called monoclonal antibodies and is designed to reduce the frequency of relapses and slow down disease progression in patients with this autoimmune condition. The clinical trial aims to evaluate how well the medication works in pediatric patients, how it compares to another treatment called fingolimod, and to monitor its long-term safety and effectiveness.

Investigated diseases

Relapsing Multiple Sclerosis – Relapsing Multiple Sclerosis is a form of multiple sclerosis characterized by episodes of new or worsening symptoms followed by periods of partial or complete recovery. During relapses, the immune system mistakenly attacks the protective covering of nerve fibers in the brain and spinal cord, causing inflammation and damage. This damage disrupts the normal flow of electrical signals along the nerves, leading to various neurological symptoms. Symptoms can include vision problems, muscle weakness, difficulty with coordination and balance, numbness or tingling, and cognitive changes. The relapses can last from days to weeks, and between episodes patients may experience stable periods with no new symptoms. Over time, the accumulated damage from repeated relapses can lead to increasing disability and persistent symptoms.