Not recruiting

Study comparing subcutaneous versus intravenous ublituximab in patients with relapsing multiple sclerosis

Fast replyInvestigationalNo placebo

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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 patients with Relapsing Multiple Sclerosis, a condition where the immune system attacks the protective covering of nerve cells, leading to recurring episodes of neurological symptoms. The study will test a medication called ublituximab (also known as TG-1101), which is designed to target specific immune cells involved in the disease process.

The purpose of this research is to compare two different ways of giving the same medicine: under the skin (subcutaneous injection) versus directly into a vein (intravenous administration). The study will examine how the body processes the medication when given through these different methods and evaluate its effects on disease symptoms.

During the study, participants will receive ublituximab either as an injection under the skin or through an intravenous infusion. The research team will monitor the participants' response to treatment, including how well the medication is working and any side effects that may occur. The study will track changes in participants' condition through various medical assessments and imaging tests.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening
Your eligibility for the study will be evaluated based on specific criteria including:
- Age between 18 and 65 years
- Confirmed diagnosis of relapsing multiple sclerosis (RMS)
- Disability status score (EDSS) of 5.5 or lower
Female participants who can become pregnant must use effective birth control during the study and for a period after the last dose
Step 2
Treatment assignment
You will be randomly assigned to one of two treatment groups:
- Group 1: Subcutaneous ublituximab (injection under the skin)
- Group 2: Intravenous ublituximab (administration through a vein)
Step 3
Treatment period
The study medication (ublituximab) will be given in one of two forms:
- As a solution for injection under the skin, or
- As a concentrate solution for infusion into a vein
Regular monitoring will track:
- Changes in your B-cell levels (specific type of blood cells)
- Any side effects that may occur during treatment
Step 4
Study duration
The study is scheduled to run from September 2025 to March 2028
Your participation duration will be specified in the detailed study schedule
Step 5
Monitoring and assessments
Throughout the study, you will undergo:
- Regular medical examinations
- Blood tests to measure drug levels in your body
- Monitoring of your multiple sclerosis symptoms
- Assessment of any side effects

Who can join the trial?

5 criteria

Age between 18 and 65 years old
Must have a confirmed diagnosis of Relapsing Multiple Sclerosis (RMS), which is a form of multiple sclerosis where symptoms come and go
Must have an EDSS score of 5.5 or lower during screening (EDSS is a scale that measures disability level in multiple sclerosis, where lower scores mean better physical function)
Both men and women can participate in the study
Women who can become pregnant must agree to use highly effective birth control methods during the study and for a period after receiving the last dose of the study medication

Who cannot join the trial?

14 criteria

History of severe allergic reactions or anaphylaxis (life-threatening allergic reaction)
Active or chronic infections, including hepatitis B, hepatitis C, or tuberculosis
Current diagnosis of cancer or history of cancer in the past 5 years (except for treated skin cancer)
Severe liver disease or abnormal liver function tests
Severe kidney disease or significantly reduced kidney function
Uncontrolled high blood pressure
History of heart problems including heart attack or unstable heart disease
Pregnant or breastfeeding women
Use of other medications for multiple sclerosis within the past 6 months
Participation in other clinical trials within the past 30 days
History of drug or alcohol abuse within the past year
Mental health conditions that could interfere with study participation
Inability to comply with study procedures or follow-up visits
Any condition that, in the opinion of the study doctor, would make participation unsafe

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Verified sites

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

Fakultni Nemocnice Hradec Kralove
Verified
Novy Hradec Kralove, Czechia
KBC Zagreb
Responsive
Zagreb, Croatia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Responsive
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

Ublituximab
(intravenous form) is a medication that targets specific cells in the immune system. It is administered through a vein and is used in the treatment of multiple sclerosis. This medication works by reducing the number of certain immune cells that may be involved in causing inflammation and damage to the nervous system.
Ublituximab
(subcutaneous form) is the same medication but administered as an injection under the skin. This form is being tested to see if it works as effectively as the intravenous version while potentially offering more convenience to patients with multiple sclerosis.

Ublituximab

What is already known about the treatment

Ublituximab - A novel monoclonal antibody administered both intravenously and subcutaneously for the treatment of relapsing forms of Multiple Sclerosis. This medication belongs to the class of targeted immunotherapy drugs that work by binding to CD20 proteins found on B cells, leading to their depletion in the immune system, which helps reduce inflammation and disease progression in MS patients. Ublituximab is currently being studied in Phase 3 clinical trials to compare the effectiveness and safety of subcutaneous versus intravenous administration methods, with particular focus on its pharmacokinetics and pharmacodynamic properties, making it a promising treatment option in the field of multiple sclerosis management.

Investigated diseases

Multiple Sclerosis (Relapsing Form) - A chronic neurological condition affecting the central nervous system, where the immune system attacks the protective covering of nerve fibers. In the relapsing form, patients experience episodes of new or worsening symptoms (relapses) followed by periods of partial or complete recovery (remissions). During relapses, patients may experience various symptoms including vision problems, muscle weakness, balance issues, and fatigue. The disease typically shows a pattern of relapses and remissions, with symptoms varying among individuals. Between relapses, patients may experience relatively stable periods with minimal or no progression of symptoms.