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Study of IMVT-1402 in Adults with Mild to Severe Generalized Myasthenia Gravis

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 clinical trial focuses on evaluating a new medication called IMVT-1402 for people who have Generalized Myasthenia Gravis, a condition that causes muscle weakness affecting various parts of the body. The weakness typically worsens with activity and improves with rest, making daily activities challenging for those affected.

The study aims to determine how well IMVT-1402 works and how safe it is for patients with mild to severe forms of the disease. The medication is given as a subcutaneous injection, which means it is injected under the skin. Some participants will receive IMVT-1402, while others will receive a placebo during the study.

The treatment period lasts 26 weeks, during which participants will receive regular doses of either IMVT-1402 or placebo. The study will measure how the treatment affects participants' ability to perform daily activities and their overall muscle strength. Throughout the study, participants will be monitored for any changes in their condition and any potential side effects of the treatment.

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 evaluation

    Your condition will be assessed using the Myasthenia Gravis Foundation of America (MGFA) classification system to confirm mild to severe generalized myasthenia gravis

    Your daily living activities will be evaluated using the MG-ADL score, which must be 6 or higher

    You will need to provide written informed consent after reviewing all study information

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either IMVT-1402 or a placebo (inactive substance)

    Neither you nor the study staff will know which treatment you are receiving

    The medication will be given as an injection under the skin (subcutaneous injection)

  3. Step 3

    Treatment period

    You will receive regular subcutaneous injections of either IMVT-1402 or placebo

    Your daily activities will be monitored using the MG-ADL score

    Your muscle strength will be evaluated using the Quantitative Myasthenia Gravis (QMG) score

  4. Step 4

    Monitoring and assessment

    Regular evaluations will track changes in your condition

    Your progress will be measured by comparing current scores to your initial assessment

    The study will monitor if you achieve an MG-ADL score of 0 or 1

    The study will track if you achieve 50% or greater improvement in your MG-ADL score

  5. Step 5

    Study completion

    The study is expected to continue until December 31, 2027

    Final assessments will be conducted to evaluate the overall effectiveness of the treatment

    Your participation will help determine if IMVT-1402 is effective for treating generalized myasthenia gravis

Who can join the trial?

6 criteria

  • Must be able to understand the study requirements, provide written consent, and follow all study procedures
  • Must be diagnosed with mild to severe generalized Myasthenia Gravis (gMG) classified as Class II, III, or IV according to the Myasthenia Gravis Foundation of America scale (this scale measures how severe the disease symptoms are)
  • Must have a score of 6 or higher on the MG-ADL scale (this is a questionnaire that measures how the disease affects daily activities) during both the screening visit and the first day of the study
  • Must be an adult (18 years or older)
  • Can be either male or female
  • Must not be from a vulnerable population group (such as prisoners, mentally disabled persons, or other protected groups)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Previous participation in clinical trials within the last 30 days
  • Pregnancy or breastfeeding
  • History of allergic reactions to similar medications
  • Presence of other autoimmune disorders (conditions where the immune system attacks healthy cells)
  • Current treatment with immunosuppressive medications (drugs that reduce immune system activity)
  • Significant heart, liver, or kidney disease
  • Active infections or recent vaccinations
  • History of thymoma (tumor of the thymus gland) or previous thymectomy
  • Uncontrolled high blood pressure or diabetes
  • Mental conditions that could interfere with following study procedures
  • Use of medications that could interact with the study drug
  • Unable to provide informed consent
  • History of substance abuse in the past 5 years
  • Abnormal laboratory test results that could indicate other health issues
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Investigated drugs

  • IMVT-1402

    is an investigational medication being studied for the treatment of generalized myasthenia gravis, which is an autoimmune disorder that causes muscle weakness. This medication aims to reduce the severity of symptoms in patients with mild to severe forms of the disease by targeting the underlying immune system mechanisms that cause muscle weakness.

  • Placebo

    is an inactive substance that contains no medication. It is used as a comparison to measure the true effects of the active medication being tested in the study.

What is already known about the treatment

IMVT-1402 - A novel investigational drug being studied in Phase 3 clinical trials for the treatment of Generalized Myasthenia Gravis, a rare autoimmune neuromuscular disorder. This medication is currently undergoing evaluation through a randomized, placebo-controlled, double-blind study to assess its efficacy and safety in patients with mild to severe disease. While the specific mechanism of action involves targeting the autoimmune response in Myasthenia Gravis, the medication's administration method and complete pharmacological classification are still being established through ongoing clinical research. The primary goal of the treatment is to improve patients' daily living activities as measured by changes in the MG-ADL (Myasthenia Gravis Activities of Daily Living) score.

Investigated diseases

Generalized Myasthenia Gravis - A rare autoimmune disorder that causes muscle weakness throughout the body. The condition occurs when the immune system mistakenly attacks the connection between nerves and muscles, specifically targeting the acetylcholine receptors at the neuromuscular junction. This interference disrupts the normal communication between nerves and muscles, leading to muscle fatigue and weakness that typically worsens with activity and improves with rest. The weakness can affect multiple muscle groups, including those controlling eye movements, facial expressions, chewing, swallowing, speaking, and limb movements. The symptoms often fluctuate, with periods of greater and lesser severity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515979-35-00Protocol codeIMVT-1402-3101Estimated enrolment231 patientsSponsorImmunovant Sciences GmbH

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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.

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