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Study on Ublituximab and Drug Combination for Patients with Myasthenia Gravis or Relapsing Multiple Sclerosis

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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 effects of a medication called ublituximab in patients with certain autoimmune diseases, specifically Myasthenia Gravis and Relapsing Multiple Sclerosis. Autoimmune diseases occur when the body's immune system mistakenly attacks its own tissues. Ublituximab is a type of medication known as a monoclonal antibody, which is designed to target specific cells in the immune system. The purpose of this study is to understand how the body processes and responds to ublituximab when it is given either through a vein (intravenous) or under the skin (subcutaneous).

During the study, participants will receive ublituximab and may also receive other medications such as methylprednisolone, cetirizine, paracetamol, diphenhydramine, dexamethasone, and sodium chloride. These medications are commonly used to manage symptoms or support the treatment process. The study will monitor how ublituximab is absorbed, distributed, and eliminated by the body, as well as its effects on certain immune cells called B-cells.

The trial will take place over several years, with participants attending regular visits to receive the medication and undergo assessments. These assessments will help researchers gather important information about the safety and effectiveness of ublituximab in treating these autoimmune conditions. The study aims to provide valuable insights that could improve treatment options for patients with Myasthenia Gravis and Relapsing Multiple Sclerosis.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.

    Eligibility criteria include age, diagnosis, and stability of current treatments. For example, patients with myasthenia gravis must have been on a stable dose of certain medications for specified periods.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to assess the current health status. This may involve physical examinations and laboratory tests.

    The evaluation helps establish a starting point for monitoring changes during the trial.

  3. Step 3

    Medication administration

    The trial involves the administration of ublituximab, which can be given either intravenously or subcutaneously.

    Other medications such as methylprednisolone, cetirizine, paracetamol, diphenhydramine, dexamethasone, and sodium chloride may also be administered as part of the treatment protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to evaluate the effects of the treatment. This includes pharmacokinetic assessments and B-cell counts.

    Follow-up visits are scheduled to track progress and manage any side effects.

  5. Step 5

    Completion of trial

    The trial is expected to continue until January 2027. Upon completion, a final assessment is conducted to evaluate the overall impact of the treatment.

    Participants may be asked to provide feedback on their experience during the trial.

Who can join the trial?

9 criteria

  • For patients with **Myasthenia Gravis (MG)**:
    • Must be receiving treatment with specific medications and have been on a stable dose for a certain period before joining the study.
    • Must be at least 18 years old at the time of signing the consent form.
    • Must have been diagnosed with MG at least 6 months before signing the consent form.
    • Must have a positive test for specific antibodies related to MG, confirmed during screening.
    • Must meet certain clinical classifications and scores during screening.
    • For patients with **Relapsing Multiple Sclerosis (RMS)**:
      • Must be between 18 and 65 years old.
      • Must have a diagnosis of RMS according to specific criteria.
      • Must have a certain score on a disability scale during screening.
      • Female participants who can have children must agree to use effective birth control from the time of consent and for 6 months after the last dose of the study medication.

Who cannot join the trial?

11 criteria

  • Patients with a history of severe allergic reactions to similar medications.
  • Patients who are currently pregnant or breastfeeding.
  • Patients with active infections that require treatment.
  • Patients with a history of cancer within the last five years, except for certain skin cancers.
  • Patients with significant heart problems, such as heart failure or recent heart attack.
  • Patients with uncontrolled high blood pressure.
  • Patients with liver disease that is not well managed.
  • Patients with kidney disease that is not well managed.
  • Patients who have received another investigational drug within the last 30 days.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

Ublituximab is a medication being studied for its effects on autoimmune diseases. It is administered either through an injection into a vein (intravenous) or under the skin (subcutaneous). The study aims to understand how the body processes this medication and how it affects the immune system in patients with autoimmune conditions.

What is already known about the treatment

Ublituximab – Ublituximab is administered either intravenously or subcutaneously, depending on the specific needs of the patient. It is currently being studied in clinical trials for its effectiveness in treating autoimmune diseases such as Myasthenia Gravis and Relapsing Multiple Sclerosis. The medication works by targeting a specific protein on the surface of certain immune cells, helping to reduce inflammation and modulate the immune response. Ublituximab is classified as a monoclonal antibody, which is a type of biological therapy designed to interfere with specific pathways in the immune system.

Investigated diseases

  • Myasthenia Gravis

    Myasthenia Gravis is a chronic autoimmune disorder that affects the communication between nerves and muscles, leading to muscle weakness. It occurs when the immune system mistakenly attacks the connections between nerves and muscles, disrupting the transmission of nerve signals. This results in varying degrees of muscle weakness, which can worsen with activity and improve with rest. Commonly affected muscles include those controlling eye and eyelid movement, facial expression, and swallowing. The severity of symptoms can fluctuate, and they may become more pronounced during periods of physical exertion or stress.

  • Relapsing Multiple Sclerosis

    Relapsing Multiple Sclerosis is a form of multiple sclerosis characterized by episodes of new or worsening symptoms, known as relapses, followed by periods of partial or complete recovery. It is an autoimmune disease where the immune system attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. Symptoms can vary widely, including fatigue, numbness, vision problems, and difficulty with coordination and balance. The disease progresses with alternating periods of relapses and remissions, where symptoms may improve or disappear. Over time, relapses can lead to a gradual increase in disability.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509555-13-00Protocol codeTG1101-RMS-SC101Estimated enrolment164 patientsSponsorTg Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).