Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study on Nipocalimab for Adults with Generalized Myasthenia Gravis

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying a condition called Generalized Myasthenia Gravis, a disease that causes muscle weakness. The study is testing a treatment called nipocalimab, which is given as an infusion, meaning it is delivered directly into the bloodstream through a vein. The trial will compare the effects of nipocalimab to a placebo, which is a substance with no active medication, to see how well it works and how safe it is for people with this condition.

The main goal of the study is to evaluate how effective nipocalimab is in improving the daily living activities of people with Generalized Myasthenia Gravis. Participants in the study will receive either nipocalimab or a placebo, and their progress will be monitored over a period of time. The study will look at changes in their ability to perform daily activities and any side effects they might experience.

Participants will be randomly assigned to receive either the treatment or the placebo, and neither the participants nor the researchers will know who is receiving which, to ensure unbiased results. The study will take place over several weeks, and participants will have regular check-ups to assess their health and the effects of the treatment. The information gathered from this study will help determine if nipocalimab is a safe and effective treatment option for people with Generalized Myasthenia Gravis.

The research process

The trial runs in 6 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 a physical examination.

    A blood test is performed to ensure the presence of specific antibodies related to generalized myasthenia gravis.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, nipocalimab, or a placebo, which is a saline solution.

    This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment phase

    The treatment involves intravenous infusions of nipocalimab or placebo.

    Infusions are administered according to a schedule determined by the study protocol, typically over a period of several weeks.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the participant's response to the treatment. This includes evaluating changes in symptoms using the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale.

    Blood samples are collected periodically to monitor safety and measure the levels of the study medication in the body.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment phase, a comprehensive evaluation is performed to assess the overall effectiveness and safety of the treatment.

    Participants may be asked to complete questionnaires and undergo additional medical examinations.

  6. Step 6

    Follow-up

    After completing the treatment phase, participants enter a follow-up period where their health and any long-term effects of the treatment are monitored.

    This phase may involve periodic visits to the study site for assessments and discussions with the study team.

Who can join the trial?

14 criteria

  • Must be at least 18 years old at the time of giving consent.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control methods during the study and for 30 days after the last dose.
  • Women must agree not to donate eggs during the study and for 30 days after the last dose.
  • Men must use condoms during the study and for 90 days after the last dose. If their partner can have children, they are encouraged to use effective birth control methods.
  • Men must agree not to donate sperm during the study and for 90 days after the last dose.
  • Must sign a form indicating understanding of the study and willingness to participate and follow all procedures.
  • Must be able to read and write.
  • Must have a diagnosis of **Generalized Myasthenia Gravis** with muscle weakness and a positive test for specific antibodies related to the condition.
  • Must have a score of 6 or higher on a specific scale used to measure daily living activities affected by **Myasthenia Gravis**.
  • Must have a less than ideal response to current stable treatment for **Generalized Myasthenia Gravis**.
  • Can use herbal or alternative remedies if approved by the study doctor, but must keep the dose and schedule stable during the study.
  • If the spleen has been removed, must be at least 3 months post-surgery and vaccinated according to guidelines.
  • Must have good vein access for receiving the study drug and taking blood samples.
  • Recommended to be up to date on all vaccinations, including COVID-19, at least 2 weeks before study visits.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of Generalized Myasthenia Gravis. This is a condition that affects the muscles, making them weak and tired.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study instructions or take the treatment as directed.
  • Patients who are part of a vulnerable population that the study cannot safely include.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Nipocalimab is a medication being studied for its effectiveness in treating adults with generalized myasthenia gravis, a condition that causes muscle weakness. The trial aims to see how well nipocalimab works in improving the daily living activities of people with this condition. The study also looks at the safety of the medication and how it behaves in the body.

What is already known about the treatment

Nipocalimab – Nipocalimab is administered intravenously and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating generalized myasthenia gravis, a chronic autoimmune neuromuscular disorder. The medication is not yet widely available in medical practice, as it is still under investigation. It works by targeting and blocking a specific receptor involved in the immune response, potentially reducing the harmful antibodies that attack the body's own tissues. Nipocalimab is classified as an immunomodulatory agent, aiming to modulate the immune system's activity to alleviate symptoms of the disease.

Investigated diseases

Generalized Myasthenia Gravis – Generalized 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 body's own tissues, specifically targeting the receptors that receive nerve signals. This results in fluctuating muscle weakness and fatigue, which can affect various muscle groups, including those responsible for eye movement, facial expression, and swallowing. The severity of symptoms can vary, often worsening with activity and improving with rest. Over time, the condition may lead to more persistent muscle weakness, impacting daily activities and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504152-97-00Protocol codeMOM-M281-011Estimated enrolment274 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.