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

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What is this study about?

This clinical trial is focused on studying the disease known as Generalized Myasthenia Gravis, a condition that causes muscle weakness due to the immune system attacking the communication between nerves and muscles. The study will evaluate a treatment called Gefurulimab, which is administered as a solution for injection. This treatment is being compared to a placebo to assess its effectiveness and safety in managing the symptoms of this disease.

The purpose of the study is to determine how well Gefurulimab works in improving the daily living activities of adults with Generalized Myasthenia Gravis. Participants in the study will receive either the treatment or a placebo and will be monitored over a period of time to observe any changes in their condition. The study aims to see if there is a significant improvement in the ability to perform daily activities and a reduction in muscle weakness.

Throughout the study, participants will undergo regular assessments to track their progress and any changes in their symptoms. The study is designed to provide valuable information on the potential benefits of Gefurulimab for individuals living with Generalized Myasthenia Gravis, contributing to the understanding of how this treatment can help manage the disease.

1 joining the study

Upon joining the study, the participant is required to meet specific criteria, including being 18 years or older and having a diagnosis of generalized myasthenia gravis with muscle weakness, as defined by the Myasthenia Gravis Foundation of America (MGFA) Class II, III, or IV.

A positive serological test for autoantibodies against the acetylcholine receptor (AChR) is also necessary.

2 treatment phase

During the treatment phase, participants receive either the investigational drug gefurulimab or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.

The specific dosage and frequency of administration are determined by the study protocol, which is designed to evaluate the safety and effectiveness of the treatment.

3 evaluation of treatment effectiveness

The primary goal is to assess changes in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score at week 26. This score helps measure the impact of the treatment on daily activities.

Secondary evaluations include changes in the Quantitative Myasthenia Gravis (QMG) total score and the Myasthenia Gravis Composite (MGC) total score, both at week 26, as well as the percentage of responders based on score reductions.

4 completion of the study

The study is expected to conclude by July 31, 2027. Participants will have completed all required assessments and treatments by this time.

Final evaluations will be conducted to determine the overall effectiveness and safety of the treatment.

Who Can Join the Study?

  • Must be at least 18 years old at the time of signing the informed consent.
  • Must have a diagnosis of Myasthenia Gravis (MG), which is a condition that causes muscle weakness. The muscle weakness should be generalized, meaning it affects multiple areas of the body, and should meet the clinical criteria defined by the Myasthenia Gravis Foundation of America (MGFA) as Class II, III, or IV.
  • Must have a positive serological test, which is a blood test, showing the presence of autoantibodies against acetylcholine receptor (AChR). These are specific proteins in the blood that are involved in MG.

Who Cannot Join the Study?

  • Patients who do not have Generalized Myasthenia Gravis with autoantibodies against the acetylcholine receptor (AChR) cannot participate. This means the study is only for those with a specific type of muscle weakness condition.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is for specific groups of people.
  • Both male and female patients can participate, but those who do not meet other criteria cannot join.
  • Patients who are considered part of a vulnerable population may not be eligible. This refers to groups who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Lublin Poland
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Lille Lille France
Hospital Universitario De Navarra Pamplona Spain
Neurologia Slaska Centrum Medyczne Katowice Poland

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Klinikum Wels-Grieskirchen GmbH Wels Austria
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Hospital Universitario Infanta Sofía San Sebastian De Los Reyes Spain
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universita’ Di Pisa Pisa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Ludwig Maximilian University Of Munich Munich Germany
Aalborg University Hospital Aalborg Denmark
Centre Hospitalier Universitaire De Nice Nice France
Rigshospitalet Copenhagen Denmark
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Rhyhnlasvjliijtd Hufzowtd Garches France
Mlelsuzsq Izhkrbblzu Czkzjsei Smvrjjos Sdp z olqp Warsaw Poland
Auotpheyo Uqf Amsterdam The Netherlands
Adxbgtgauj Pqwctjek Hvfrlkaq Dc Moultclpd Marseille France
Uuszrvjuqkqaucnbyzkzc Dsexztpawlu Ady Duesseldorf Germany
Afpxovu Oczgzzsahxk Pvge Gxtzlaoo Xacew Bergamo Italy
Fwhczmdfv Pfmn Ls Ixfrineavunug Bkvtvpeji Ddh Hcfskkwu Uznsbnwhwcebq Li Pge Madrid Spain
Hdfvjhoh Uxnwxwdixmpfa Hdfcllxo Tqteb y Pahilb Ijpuhzcy Cunpyf duysroxrrkwmcsuon (oyxh Badalona Spain
Khfuwsmoi Sdwauxo Staqclcnbtxxktq ik Jfmp Pzmkt Id Cracow Poland
Hxeluowc Uadkrchjykxghk Shbwslbhve &ypruvh Hismvjs dq Haiklykvegx STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.11.2022
Denmark Denmark
Not recruiting
30.11.2022
France France
Not recruiting
30.11.2022
Germany Germany
Not recruiting
30.11.2022
Italy Italy
Not recruiting
30.11.2022
Poland Poland
Not recruiting
30.11.2022
Portugal Portugal
Not recruiting
30.11.2022
Spain Spain
Not recruiting
30.11.2022
The Netherlands The Netherlands
Not recruiting
30.11.2022

Trial locations

Investigated drugs:

ALXN1720 is a medication being studied for its potential to treat adults with generalized myasthenia gravis, a condition that causes muscle weakness. The trial aims to evaluate how effective and safe this medication is in improving symptoms of the disease.

Investigated diseases:

Generalized Myasthenia Gravis with autoantibodies against acetylcholine receptor (AChR) – This is a chronic autoimmune disorder where the body’s immune system mistakenly attacks the communication between nerves and muscles. It specifically targets the acetylcholine receptors, which are crucial for muscle contraction. As a result, individuals experience muscle weakness that can vary in severity and may worsen with activity. Commonly affected muscles include those controlling the eyes, face, throat, and limbs. The condition can lead to difficulties in speaking, swallowing, and breathing. Symptoms often fluctuate, with periods of improvement and worsening.

Trial ID:
2023-508284-77-00
Protocol code:
ALXN1720-MG-301
NCT ID:
NCT05556096
Trial Phase:
Therapeutic confirmatory (Phase III)

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