Study on the Effectiveness and Safety of Batoclimab for Adults with Generalized Myasthenia Gravis

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Katholisches Klinikum Bochum gGmbH Bochum Germany
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Universita Degli Studi Di Brescia Brescia Italy
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Neuroprotect Sp. z o.o. Warsaw Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Universitaetsklinikum Leipzig AöR Leipzig Germany
Centrum Medyczne Hope Clinic Lublin Poland
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Nlwxjsnkipmd Zxlghd Omiyhq Zsqiftkczg Wlpibalnkzifrxjeddro Pphysort Loqubchi Szpdxsjn Lvsw Srguvkwjwxnk Katowice Poland
Moqplwsjo i Pgmqqtsle Lzwmybv Sbxgzb Pxwwpswzfhb Cracow Poland
Uudsjnvhdgygua Cktmftr Kefnnvdin Gdansk Poland
Hbliwtyy Dz Lw Seidn Ccin I Suiw Pmc Barcelona Spain
Azsaykg Oveqmkxdplm Ptrl Govqsvuz Xsfoa Bergamo Italy
Fmzxuxcll Penx Lw Iwkklxztfhart Bkpbobhfw Ddy Hqczibrw Uzhdxkprwubcm Lx Pxu Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.06.2022
Hungary Hungary
Not recruiting
01.06.2022
Italy Italy
Not recruiting
01.06.2022
Poland Poland
Not recruiting
01.06.2022
Romania Romania
Not recruiting
01.06.2022
Spain Spain
Not recruiting
01.06.2022

Trial locations

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.

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 ID:
2024-512258-91-00
Protocol code:
IMVT-1401-3101
Trial Phase:
Therapeutic confirmatory (Phase III)

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