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Phase 2 Study to Evaluate Efficacy and Safety of Ublituximab Maintenance after Induction with Efgartigimod Alfa in Adults with Myasthenia Gravis

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What is this trial about?

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

Myasthenia Gravis is a chronic autoimmune disease that causes muscle weakness, especially after activity. The study examines a maintenance therapy with ublituximab, a monoclonal antibody given by infusion, after an initial course of VYVGART (efgartigimod alfa), also delivered by infusion. A control group will receive a placebo instead of the maintenance drug.

The purpose of the study is to assess whether the maintenance therapy improves muscle strength and daily function. Participants will first receive the induction medication for a short period, then be randomly assigned to receive either the maintenance antibody or the placebo for several months, with regular clinic visits for safety checks and questionnaires.

During the study, blood samples will be taken to measure B-cell counts and levels of autoantibodies, and participants will complete simple tests such as the Quantitative Myasthenia Gravis (QMG) score, which evaluates muscle strength, and the Myasthenia Gravis‑Activities of Daily Living (MG‑ADL) questionnaire, which asks about everyday tasks. The study will monitor any side effects and record when additional rescue medication is needed.

The research process

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

  1. Step 1

    Study Entry and Consent

    After agreeing to participate, you will sign an informed consent form that explains the purpose of the study, the procedures involved, and your rights as a participant.

    You will receive a copy of the study information and be assigned a unique study identification number.

  2. Step 2

    Baseline Assessments

    During the first visit, a series of medical examinations will be performed, including blood tests and physical measurements.

    You will complete questionnaires that evaluate daily activities and muscle strength, such as the Myasthenia Gravis‑Activities of Daily Living (MG‑ADL) and the Quantitative Myasthenia Gravis (QMG) score.

    These assessments establish a reference point for evaluating changes during the trial.

  3. Step 3

    Induction Treatment with Efgartigimod Alfa

    You will receive an intravenous (IV) infusion of efgartigimod alfa at a dose of 10 mg per kilogram of body weight.

    The infusion is administered through a vein by a qualified health professional and follows the schedule defined in the study protocol.

    Efgartigimod alfa is a medication that temporarily reduces the activity of the immune system, helping to control symptoms of Myasthenia Gravis.

  4. Step 4

    Randomization to Maintenance Therapy

    After completing the induction phase, you will be randomly assigned to receive either the active medication (ublituximab) or a matching placebo.

    The study is double‑blind, meaning neither you nor the treating staff will know which treatment you are receiving.

  5. Step 5

    Maintenance Infusions

    If assigned to the active group, you will receive an intravenous infusion of ublituximab at a dose of 450 mg per infusion.

    If assigned to the placebo group, you will receive a matching infusion that does not contain any active drug.

    Infusions are given at the intervals specified by the study protocol and continue for the duration of the maintenance phase.

  6. Step 6

    Regular Monitoring Visits

    Throughout the study, you will attend scheduled clinic visits for safety monitoring, which include blood draws, physical examinations, and assessment of any side effects.

    At each visit you will again complete the MG‑ADL, QMG, and other quality‑of‑life questionnaires to track changes over time.

    The study team will also measure laboratory parameters such as CD19+ B‑cell counts and drug levels in the blood.

  7. Step 7

    Study Completion and Final Evaluation

    At the end of the study period, a final set of assessments will be performed, mirroring the baseline evaluations.

    You will receive a summary of the study results that pertain to your participation, and the study medication will be discontinued.

    Any additional follow‑up required for safety will be arranged according to the study protocol.

Who can join the trial?

7 criteria

  • Be at least 18 years old when you sign the consent form.
  • Have a confirmed diagnosis of Myasthenia Gravis proven by one of the following: a special nerve‑muscle test called single‑fiber electromyography or repetitive nerve stimulation, a medication reaction test called an anticholinesterase test (for example, the edrophonium test), or clear improvement of symptoms when taking oral medicines that increase nerve signals (acetylcholinesterase inhibitors).
  • Be classified by your doctor as having a moderate to severe level of disease (called MGFA class II, III, or IV).
  • Score at least 6 but no more than 10 on the MG‑ADL questionnaire (which measures daily living impact) with more than half of the points coming from symptoms that are not eye‑related, or have a score of 11 or higher.
  • Score 11 or higher on the QMG test, which measures muscle weakness.
  • If you are already taking any of the study’s required medicines, you must have been on a stable dose of those medicines for the time period required before the screening visit.
  • Women who could become pregnant must agree to use an effective form of contraception from the time you sign the consent until six months after the last dose of the study drug.

Who cannot join the trial?

18 criteria

  • Having another ongoing immune system disease besides Myasthenia Gravis, such as rheumatoid arthritis, scleroderma, Sjögren’s syndrome, Crohn’s disease, ulcerative colitis, or having an inherited or medication‑caused immune deficiency.
  • Having serious problems with major organs (for example the liver, kidneys, or heart) that are shown by laboratory test results.
  • Having ever had a life‑threatening reaction or severe allergy (including anaphylaxis) to injections or infusions, especially to the study drug ublituximab or related medicines.
  • Having a current infection or a history of serious repeated infections, including HIV (human immunodeficiency virus).
  • Having active hepatitis B infection (shown by a positive hepatitis B surface antigen or core antibody test) or chronic hepatitis C infection; for hepatitis C you must have a negative PCR test (no virus detected) to be eligible.
  • Having or being suspected of having progressive multifocal leukoencephalopathy (PML), a rare brain infection.
  • Receiving any vaccine, including live‑attenuated vaccines such as the chicken‑pox (varicella‑zoster) or measles vaccine, within four weeks before the study starts.
  • Having any severe or uncontrolled health problem that would make it difficult to stay in the study or complete its procedures.
  • Being pregnant or breastfeeding.
  • Being unwilling or unable to follow the study’s rules and required follow‑up visits.
  • Having only eye‑muscle weakness (MGFA class I) or showing signs of a severe Myasthenia Gravis crisis (MGFA class V) at any time during screening, as judged by the investigator.
  • Using any of the following medicines within the past four weeks: intravenous or subcutaneous immune globulin (IVIg or SCIg), plasma exchange (PLEX), cyclosporine (except eye drops), tacrolimus (except topical), methotrexate, thalidomide, or tofacitinib.
  • Using any of the following medicines within the past three months: tocilizumab, belimumab, complement inhibitors, cyclophosphamide, abatacept, etanercept, mitoxantrone, or sirolimus.
  • Having received a B‑cell‑depleting monoclonal antibody therapy (a type of targeted immune‑system drug) within the past twelve months.
  • Having previously received any non‑monoclonal B‑cell‑depleting therapy, alemtuzumab, total lymphoid irradiation, bone‑marrow transplant, T‑cell vaccination therapy, or natalizumab.
  • Having had a thymectomy (removal of the thymus gland) within the past twelve months, or planning to have a thymectomy during the study.
  • Having a history of cancer, except for skin basal cell or in‑situ squamous cell carcinoma that has been fully treated, a malignant thymoma removed more than five years ago with no active disease, or a benign thymoma removed more than one year ago with no spread (no metastases) and no recent treatment.
  • Having taken any other experimental drug within a time period equal to five half‑lives of that drug, or having undergone any experimental procedure within the past four weeks.
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Investigated drugs

  • ublituximab

    is a medication given through an IV infusion. In this study it is used as the main treatment that participants continue to receive after the initial therapy. It belongs to a group of drugs called monoclonal antibodies, which help the immune system work more normally. The goal is to keep the symptoms of myasthenia gravis under control over time.

  • VYVGART

    (efgartigimod alfa) is also given by IV infusion. In the trial it is used first, before the maintenance drug, to “induce” a response. It works by lowering the harmful antibodies that cause myasthenia gravis, giving the body a chance to improve. After this induction phase, participants move on to the maintenance medication.

What is already known about the treatment

  • Ublituximab

    This medication is given as an intravenous (IV) infusion in a solution for infusion. It is an approved drug for certain blood cancers and is being studied in medical literature for other uses. In this trial it is used to treat adults with Myasthenia Gravis by targeting a protein called CD20 on certain immune cells, which helps lower the harmful antibodies that cause symptoms. It belongs to the class of monoclonal antibodies that modify the immune system.

  • Efgartigimod alfa

    This drug is administered by IV infusion as an injection. It has received orphan‑drug status and is approved for the treatment of Myasthenia Gravis, with many studies supporting its use. It works by blocking a receptor that protects antibodies, leading to faster removal of the disease‑causing antibodies from the blood. It is classified as an FcRn antagonist, a type of immunoglobulin‑modulating therapy.

Investigated diseases

Myasthenia gravis - Myasthenia gravis is an autoimmune disorder in which antibodies block or destroy acetylcholine receptors at the neuromuscular junction, leading to impaired muscle activation. Weakness typically starts with the eye muscles, causing drooping eyelids or double vision, and can spread to facial, swallowing, and limb muscles. The weakness worsens with continued activity and improves after rest. Over time, the pattern of affected muscles may expand, and patients may experience fluctuating periods of increased symptoms. The disease course is characterized by episodes of symptom worsening called exacerbations, interspersed with more stable phases.
Trial detailsLast updated 10 Nov 2026
Age18+ yearsPhasePhase IITrial ID2025-524630-26-00Protocol codeTG1101-MG201Estimated enrolment119 patientsSponsorTg Therapeutics Inc.

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