Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on the Effectiveness and Safety of Batoclimab 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 (gMG), which is a chronic autoimmune disease that causes muscle weakness. The study is testing a treatment called Batoclimab, also known by its code name IMVT-1401. Batoclimab is a solution for injection that is administered under the skin. The trial will compare the effects of Batoclimab to a placebo, which looks like the treatment but does not contain any active ingredients.

The purpose of the study is to evaluate how effective and safe Batoclimab is as a treatment for adults with Generalized Myasthenia Gravis. Participants in the study will receive either Batoclimab or a placebo. The study will monitor changes in the participants' ability to perform daily activities, which is an important measure of how the disease affects their lives. The trial will last for several weeks, during which participants will receive regular injections and attend follow-up visits to assess their progress.

Throughout the study, researchers will carefully observe the participants to see how their symptoms change and to ensure their safety. The goal is to determine if Batoclimab can help improve the quality of life for people living with Generalized Myasthenia Gravis by reducing muscle weakness and improving their ability to carry out daily tasks. This study is an important step in finding new and effective treatments for this challenging condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction therapy

    The initial phase involves receiving the medication batoclimab or a placebo. The medication is administered as a solution for injection under the skin, known as subcutaneous injection.

    The dosage for this phase is either 680 mg or 340 mg of batoclimab, given once a week. This phase lasts for 12 weeks.

    The goal is to assess changes in daily living activities related to myasthenia gravis, measured by the MG-ADL score.

  2. Step 2

    Maintenance therapy

    Following the induction phase, participants may continue with maintenance therapy. This involves ongoing administration of the medication or placebo.

    The maintenance phase aims to evaluate the long-term effects and safety of the treatment over an extended period.

    Participants' progress is monitored through changes in the MG-ADL score and other assessments.

  3. Step 3

    Evaluation and monitoring

    Throughout the trial, regular assessments are conducted to monitor the effects of the treatment.

    Primary evaluations focus on changes in the MG-ADL score from the start of the trial to Week 12.

    Secondary evaluations include changes in the QMG score and the proportion of participants showing significant improvement.

  4. Step 4

    Completion

    The trial is expected to conclude by November 2027.

    Final assessments will determine the overall efficacy and safety of batoclimab as a treatment for generalized myasthenia gravis.

Who can join the trial?

5 criteria

  • Must be **18 years or older** at the time of the Screening Visit.
  • Must have **mild to severe generalized Myasthenia Gravis (gMG)**, which is a condition affecting muscle strength, classified as Class II, III, or IVa by the Myasthenia Gravis Foundation of America at the Screening Visit.
  • Must have a **QMG score of 11 or higher** at both the Screening and Baseline Visits. The QMG score is a way to measure the severity of muscle weakness.
  • Must have a **MG-ADL score of 5 or higher** at both the Screening and Baseline Visits. The MG-ADL score measures how the condition affects daily activities.
  • Additional requirements are specified in the study protocol.

Who cannot join the trial?

11 criteria

  • Patients with a history of severe allergic reactions to the study medication or similar drugs cannot participate.
  • Individuals who have received another investigational drug within the last 30 days are not eligible.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed, are excluded.
  • People with certain heart conditions, such as heart failure or recent heart attack, cannot join the study.
  • Participants with active infections, meaning infections that are currently causing symptoms, are not allowed.
  • Individuals with a history of cancer, except for some types of skin cancer, are excluded.
  • Pregnant or breastfeeding women cannot participate in the trial.
  • Patients with a history of drug or alcohol abuse in the past year are not eligible.
  • Individuals with certain autoimmune diseases, which are conditions where the immune system attacks the body, are excluded.
  • People who have had a major surgery within the last 8 weeks cannot join the study.
  • Participants who are unable to comply with the study procedures, meaning they cannot follow the study rules, are not allowed.
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.

Not 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

Batoclimab is a medication being studied for its effectiveness and safety in treating adults with generalized myasthenia gravis, a condition that causes muscle weakness. The trial is investigating how well batoclimab works as both an initial treatment and a long-term maintenance therapy.

What is already known about the treatment

Batoclimab – Batoclimab is administered as a subcutaneous injection, typically given once a week. It is currently being studied in clinical trials for its effectiveness and safety in treating Generalized Myasthenia Gravis (gMG). The medication works by targeting and inhibiting specific immune system components that contribute to the symptoms of gMG. Batoclimab is classified as an immunomodulatory agent, aiming to reduce the activity of antibodies that interfere with nerve-muscle communication.

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 connections between nerves and muscles, specifically targeting the acetylcholine receptors. 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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512258-91-00Protocol codeIMVT-1401-3101Estimated enrolment240 patientsSponsorImmunovant Sciences GmbH

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.