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A study of IM-101 in adults with generalized myasthenia gravis or ocular myasthenia gravis

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study is being conducted to investigate the safety and effectiveness of the drug IM-101 in adults living with Myasthenia Gravis. This condition is a disease that causes weakness in the muscles, which can affect how a person moves, speaks, or breathes. The study focuses on two specific types: Generalized Myasthenia Gravis, where muscle weakness affects many parts of the body, and Ocular Myasthenia Gravis, which primarily affects the muscles that control the eyes. Some participants may also have specific AChR antibodies, which are proteins in the blood that contribute to the disease.

Participants in the study will receive either IM-101 or a placebo, which is a substance that does not contain active medication, through an intravenous injection, a method where medicine is delivered directly into a vein. The research will involve different groups of people receiving various amounts of the medication to see how the body processes it and how it affects the disease. The study aims to determine if the treatment is safe, how well it is tolerated, and if it helps improve muscle strength and daily activities over a set period of time.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    The trial begins upon joining the study.

    The study involves receiving either the test medication, known as IM-101, or a placebo, which is a 0.9% Sodium Chloride (Normal Saline) solution that contains no active medicine.

  2. Step 2

    Administration of medication

    The test medication, IM-101 (120mg/mL), is given through an intravenous injection, which is a liquid delivered directly into a vein.

    For the multiple ascending dose portion of the study, the medication is administered in 3 separate doses.

    In the expansion cohorts, the test medication or the placebo is administered to evaluate its safety and how well it works for generalized myasthenia gravis or ocular myasthenia gravis.

  3. Step 3

    Monitoring and evaluation

    Throughout the treatment period, safety is monitored by tracking treatment-emergent adverse events, which are side effects that occur during the study.

    Physical exams and ECGs (tests that record the electrical activity of the heart) are conducted to check for any significant changes.

    For those in the expansion cohorts, effectiveness is measured by changes in symptom scores, such as the MG-ADL total score for generalized myasthenia gravis or the MGII ocular score for ocular myasthenia gravis, at week 16.

    Blood samples are collected to measure serum IM-101 concentrations (the amount of medicine in the blood) and to check levels of complement proteins, which are part of the immune system.

Who can join the trial?

21 criteria

  • You must be able and willing to provide signed informed consent, which is a written agreement to participate in the study after being fully informed of all details.
  • You must be able to travel to the study locations for scheduled visits.
  • Women who may become pregnant and men who have not had a vasectomy (a surgery to prevent pregnancy) must use highly effective contraception (birth control) during the study and for 3 months after the last dose.
  • Women of childbearing age must have a negative pregnancy test (a test to confirm you are not pregnant) through both blood and urine tests before starting.
  • For those with generalized Myasthenia Gravis (gMG), which is a condition affecting many muscles, you must have a score of 6 or higher on the MG-ADL scale (a tool used to measure how much the disease affects daily activities) and at least 50% of that score must come from symptoms other than eye problems.
  • Participants with gMG must be classified as Class II to IVa by the Myasthenia Gravis Foundation of America (MGFA), which describes the severity of the disease.
  • Participants with AChR antibody-positive gMG must test positive for anti-AChR binding antibodies (proteins in the blood that attack the connection between nerves and muscles).
  • Participants with AChR antibody-negative gMG must test negative for these same antibodies.
  • Participants with ocular Myasthenia Gravis (oMG), which only affects the eye muscles, must be classified as MGFA Class I.
  • Participants with oMG must have an MG-ADL score between 3 and 6, and these symptoms must only affect the eyes.
  • You must agree to undergo screening for genetic muscular diseases, which are muscle conditions passed down through family DNA.
  • You must be at least 18 years old but younger than 75 years old.
  • You must not have had muscle weakness as an infant; instead, weakness must have developed after the age of 16.
  • You must have been diagnosed with acquired MG (the version of the disease not present from birth) at least 6 months before the study begins.
  • Your diagnosis must be confirmed through specific medical tests, such as electromyography (a test that measures electrical activity in muscles) or by showing improvement when taking acetylcholinesterase inhibitors (medicines that help improve muscle strength).
  • Your body weight must be at least 40 kg.
  • You must be on a stable dose of your current medications, meaning your dosage has not changed recently, for specific periods:
    • Oral corticosteroids (steroid medicines used to reduce inflammation) must be at a steady dose for at least 4 weeks, with limits on the daily amount.
    • Acetylcholinesterase inhibitors must be at a steady dose for at least 4 weeks.
    • Other specific immune-related medicines must have been taken for at least 6 months, with a steady dose for the last 3 months.
    • You must have received two doses of the meningococcal vaccine (a vaccine to prevent certain bacterial infections) within the last year and at least 2 weeks before starting the study.
    • You must be vaccinated against streptococcus pneumoniae and haemophilus influenzae type B (bacteria that can cause infections like pneumonia or meningitis) according to local standards.

Who cannot join the trial?

27 criteria

  • Having used the study drug, IM-101, in the past.
  • A known or suspected history of drug or alcohol abuse or dependence (relying on substances) within 1 year before the study starts.
  • Having Hepatitis B, Hepatitis C, or HIV (a virus that affects the immune system) at the time of screening.
  • Having an active bacterial (bacteria), viral (virus), or fungal (fungus) infection within 14 days before the first dose.
  • Having a fever (a high body temperature) within 7 days before the first dose.
  • Using certain immunoglobulins (treatments that provide antibodies) or plasma exchange (a process that cleans the blood) within 4 weeks before screening.
  • Using specific immunosuppressant medications (drugs that lower the immune system response) such as rituximab, tacrolimus, or cyclophosphamide within 6 months before screening.
  • Using a neonatal Fc receptor (FcRn) blocker (a type of medication) within 6 weeks before screening.
  • Using C5 inhibitors (medications that block a part of the immune system) such as zilucoplan, eculizumab, or ravulizumab within 2 to 3 months before screening.
  • Having previously used a complement inhibitor (a medicine that targets part of the immune system) that did not work or was not tolerated well.
  • Having abnormal liver function tests, specifically high levels of AST, ALT, or total bilirubin (markers that show how well the liver is working).
  • Having a low estimated glomerular filtration rate (a measure used to see how well the kidneys are filtering the blood).
  • Participating in another medical study or using experimental therapy (untested treatments) within 30 days before screening.
  • Being pregnant, breastfeeding, or planning to become pregnant during the study.
  • Planning to have surgery that requires general anesthesia (medicine that makes you sleep so you do not feel pain) during the study.
  • Testing positive for Anti-MuSK antibodies (proteins in the blood related to muscle weakness).
  • Having any medical or mental health condition that the investigator (the doctor in charge of the study) believes might make participation unsafe or interfere with the results.
  • For those with ocular Myasthenia Gravis (oMG): having fixed ophthalmoplegia (permanent weakness or inability to move certain eye muscles).
  • For those with oMG: having a history of eyelid retraction surgery (surgery to fix eyelids that pull too far back).
  • For those with oMG: a family history of ptosis (drooping eyelids), diplopia (double vision), or other diseases that cause muscle weakness or drooping eyelids.
  • Having had a thymectomy (surgical removal of the thymus gland) within the last 12 months or planning to have one during the study.
  • A history of malignant thymoma (a tumor in the thymus gland) or having had cancer in the last 5 years, except for certain types of skin cancer that have been treated.
  • Having any immunologic disorder (a condition where the immune system does not work correctly) other than Myasthenia Gravis that would require long-term use of corticosteroids (steroid medicines).
  • Having tuberculosis (TB) (a serious bacterial infection), being treated for latent TB (an inactive form of the infection), or having been in contact with someone who has active TB.
  • A history of N. meningitidis infection (a type of bacteria that can cause serious illness).
  • Showing signs of a Myasthenia Gravis crisis or exacerbation (a sudden worsening of symptoms) within 28 days before the study begins.
  • Having a hypersensitivity (an allergic reaction) to any ingredient used in the study drug.
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Investigated drugs

IM-101 is the experimental treatment being studied to see if it is safe and effective for treating adults with generalized myasthenia gravis and ocular myasthenia gravis.

What is already known about the treatment

  • Prevenar 13

    This medication is a vaccine administered through an injection into the muscle to prevent infections caused by thirteen types of pneumococcal bacteria. It is a widely used and established medical product used to protect individuals against serious illnesses like pneumonia and meningitis. The vaccine works by teaching the immune system to recognize and fight specific sugars found on the surface of these bacteria. It is classified as a pneumococcal conjugate vaccine.

  • IM-101

    This is an investigational drug administered as an intravenous infusion into a vein. It is currently being studied in clinical trials to determine its effectiveness and safety for treating myasthenia gravis, a condition that causes muscle weakness. The substance is designed to act at a molecular level to help improve muscle function by targeting specific parts of the immune response. It is classified as an experimental therapeutic agent.

  • Sodium Chloride

    Also known as normal saline, this is a sterile solution administered through an intravenous line. It is a standard medical substance used widely in hospitals to maintain fluid balance or as a carrier for other medicines. While it does not treat specific diseases itself, it helps keep the body's hydration levels stable during medical procedures. It is classified as a saline solution used for hydration and as a placebo in this study.

  • Menveo

    This vaccine is given as an injection into the muscle to protect against several types of meningococcal bacteria that cause meningitis. It is an established medical product used globally to prevent serious bacterial infections. The vaccine works by training the body's immune system to recognize and attack specific components of the bacteria. It is classified as a meningococcal conjugate vaccine.

  • Bexsero

    This is a vaccine administered via an injection into the muscle to prevent infections caused by group B meningococcal bacteria. It is a known medical product used to provide protection against this specific type of bacterial meningitis. The vaccine functions by introducing pieces of the bacteria to the immune system so the body can learn to defend itself. It is classified as a meningococcal group B vaccine.

  • Infanrix hexa

    This medication is a combination vaccine given as an injection into the muscle to protect against six different serious diseases, including diphtheria, tetanus, and polio. It is a commonly used and well-established vaccine in pediatric medicine. The vaccine works by triggering an immune response against various bacteria and viruses, preparing the body to fight them off in the future. It is classified as a combination vaccine.

Investigated diseases

Generalized Myasthenia Gravis - This is an autoimmune disorder where the immune system mistakenly attacks the connection between nerves and muscles. It typically causes muscle weakness that worsens with activity and improves after rest. The weakness can affect various parts of the body, including the face, neck, arms, and legs. Over time, the fatigue and weakness may fluctuate or become more persistent. Ocular Myasthenia Gravis - This form of the condition specifically affects the muscles that control eye movement and eyelid opening. It often presents with drooping eyelids or double vision. The symptoms are primarily localized to the eyes and do not involve other muscle groups. This condition can progress with varying patterns of muscle weakness in the ocular region.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-522406-20-00Protocol codeIM-101_MG_2.1Estimated enrolment135 patientsSponsorImmunabs Inc.

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