Study on Ublituximab for Patients with Relapsing Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called ublituximab in individuals with relapsing multiple sclerosis. Multiple sclerosis, often referred to as MS, is a condition that affects the brain and spinal cord, leading to a range of symptoms such as problems with vision, arm or leg movement, sensation, or balance. The purpose of this study is to evaluate the long-term safety and effectiveness of ublituximab in treating this condition.

Participants in the study will receive ublituximab, which is administered as a concentrate for solution for infusion, meaning it is given through a drip into a vein. The study will follow participants over a period to monitor their health and any changes in their condition. This includes tracking the number of relapses, changes in brain scans using MRI, and any progression or improvement in disability. The study will also assess cognitive function and overall safety, including any side effects experienced during the treatment.

Throughout the study, researchers will collect data on various health parameters to understand how well ublituximab works in managing relapsing multiple sclerosis and to ensure it is safe for long-term use. This information will help in determining the potential benefits and risks of using ublituximab as a treatment option for individuals with this form of MS.

1 initial consent and eligibility

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate in the study and understand what it involves.

Eligibility will be confirmed based on your completion of a previous study and the investigator’s assessment that you may benefit from treatment with ublituximab.

2 first infusion

You will receive your first dose of ublituximab through an intravenous infusion. This means the medication is given directly into your vein.

The infusion will be administered as a concentrate for solution, which is prepared and given by healthcare professionals.

3 regular infusions

You will continue to receive ublituximab infusions at regular intervals as determined by the study protocol. The frequency and duration of these infusions will be explained to you by the study team.

Each infusion session will be monitored to ensure your safety and to manage any potential side effects.

4 ongoing assessments

Throughout the study, you will undergo regular assessments to monitor your health and the effects of the treatment.

These assessments may include MRI scans to check for changes in your brain, tests to measure your disability progression or improvement, and evaluations of your cognitive function.

5 safety monitoring

Your safety is a priority, and all adverse events, which are any unwanted effects, will be reported and evaluated.

The study team will monitor for any infusion-related reactions, infections, or other significant changes in your health.

6 completion of study

The study is expected to continue until September 2027. You will be informed about the completion process and any follow-up required after the study ends.

Your participation will contribute to understanding the long-term safety and effectiveness of ublituximab for treating relapsing multiple sclerosis.

Who Can Join the Study?

Must have completed the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study, or completed the final Week 208 visit of the TG1101-RMS201E study.
The study doctor believes you may benefit from treatment with ublituximab (a medication being tested in the study).
Must be able and willing to provide written informed consent, which means you agree to participate in the study after understanding all the details, and follow the study rules.
If you are a female who can have children, or a male with a female partner who can have children, you must agree to use a medically acceptable method of birth control.

Who Cannot Join the Study?

Patients who do not have a diagnosis of 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 for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have other medical conditions that might interfere with the study or the treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medication or similar medications cannot participate.
Patients who have a history of certain infections or diseases that could affect the study results cannot participate.
Patients who are taking medications that might interfere with the study treatment cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Neuro-Medic Sp. z o.o.	Katowice	Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
Opca Bolnica Varazdin	Varazdin	Croatia
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
KBC Zagreb	Zagreb	Croatia
Clinical Medical Center Osijek	Osijek	Croatia
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Care Clinic Sp. z o.o.	Katowice	Poland
Svhvgppbjid Pwbstngrq Sinyomu Kuawekcmz Ng 1 Ijfojvsoccpiwijagw Sikqeum Skrpphpze Ugddjkbdguyt Mvomcdqayq W Kksclrupfk	Zabrze	Poland
Cawedir Nqsucimobv Kcnhltrmz Sqznbf	Lodz	Poland

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	01.06.2020
Poland	Not recruiting	01.06.2020

Trial locations

Investigated drugs:

Ublituximab

Ublituximab is a medication being studied for its potential to help people with relapsing forms of multiple sclerosis (MS). It is designed to target and reduce certain immune cells in the body that are believed to play a role in the inflammation and damage to the nervous system seen in MS. By reducing these immune cells, ublituximab may help decrease the frequency of relapses and slow the progression of the disease. This study aims to evaluate how safe and effective ublituximab is when used over a long period.

Investigated diseases:

Relapsing multiple sclerosis

Relapsing Multiple Sclerosis – Relapsing multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by episodes of new or worsening neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During a relapse, the immune system mistakenly attacks the protective covering of nerve fibers, leading to inflammation and damage. This damage disrupts the communication between the brain and other parts of the body. Over time, the disease can lead to the accumulation of neurological disability. The progression of the disease varies among individuals, with some experiencing frequent relapses and others having long periods of stability.

Trial ID:

2024-516680-91-00

Protocol code:

TG1101-RMS303

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ublituximab for Patients with Relapsing Multiple Sclerosis

What is this study about?

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