Study on the Effectiveness and Safety of Efgartigimod in Adults with Ocular Myasthenia Gravis

3 1 1

What is this study about?

This clinical trial is focused on studying a condition called Ocular Myasthenia Gravis, which affects the muscles around the eyes, leading to weakness and fatigue. The study will evaluate a treatment called Efgartigimod, also known by its code name ARGX-113. Efgartigimod is administered as a solution for injection using a pre-filled syringe. The trial will compare the effects of Efgartigimod with a placebo, which is a substance with no active medication, to determine its effectiveness and safety in treating this condition.

The purpose of the study is to assess how well Efgartigimod works in improving symptoms of Ocular Myasthenia Gravis and to ensure it is safe for use. Participants in the study will receive either Efgartigimod or a placebo through subcutaneous injection, which means the injection is given under the skin. The study will monitor changes in the participants’ symptoms over a period of time, focusing on improvements in muscle strength around the eyes and overall well-being.

Throughout the study, participants will be closely observed for any side effects or changes in their condition. The trial aims to provide valuable information on the potential benefits of Efgartigimod for individuals with Ocular Myasthenia Gravis, contributing to the development of effective treatments for this condition. The study is designed to ensure the safety and well-being of all participants while gathering important data on the treatment’s impact.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of myasthenia gravis, and certain test results.

Participants must be at least 18 years old and have a confirmed diagnosis of ocular myasthenia gravis.

2 treatment phase

Participants receive either efgartigimod or a placebo through a subcutaneous injection. This means the injection is given under the skin.

The medication is provided in a pre-filled syringe, ensuring accurate dosage and ease of administration.

3 monitoring and assessment

Throughout the study, participants’ ocular symptoms are monitored using the MGII (PRO) ocular score. This score helps assess changes in symptoms from the start of the study to day 29.

Additional assessments include changes in MG-ADL ocular domain scores and other related scores to evaluate the impact of the treatment.

4 safety evaluations

The study includes regular checks for any adverse effects or serious adverse effects that may occur during the treatment.

Participants undergo routine laboratory tests, vital sign checks, and ECGs to ensure safety throughout the study.

5 completion of the study

The study is expected to conclude by April 2028, with ongoing assessments and data collection until that time.

Final evaluations will include a comprehensive review of all collected data to determine the efficacy and safety of the treatment.

Who Can Join the Study?

  • The person must be at least 18 years old and meet the legal age of consent for clinical studies in their area.
  • The person must have been diagnosed with myasthenia gravis, a condition that affects the muscles, and this diagnosis should be supported by a positive test for AChR-Ab (a specific antibody related to the condition) or by showing abnormal results in tests that check how nerves and muscles work together. They should also have a history of improvement with MG therapy, which is treatment for myasthenia gravis.
  • The person should be classified as MGFA Class I, which means they have weakness in the muscles around the eyes.
  • The person must have a score of at least 6 on the MGII (PRO) ocular score, which is a way to measure the severity of eye muscle weakness, with at least 2 items related to the eyes scoring at least 2.

Who Cannot Join the Study?

  • Participants with any other serious health condition that could interfere with the study.
  • Individuals who have had a recent infection or illness that could affect the study results.
  • People who are currently taking medications that might interfere with the study treatment.
  • Participants who have a history of allergic reactions to similar treatments.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Participants with a history of drug or alcohol abuse.
  • Individuals who have had a recent surgery or are planning to have surgery during the study.
  • People with a history of certain eye conditions that could affect the study.
  • Participants who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
Medical University Of Vienna Vienna Austria
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Katholieke Universiteit te Leuven Leuven Belgium
Galen Clinic Lublin Poland
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Neurologia Slaska Centrum Medyczne Katowice Poland

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Del Mar Barcelona Spain
The Cyprus Foundation For Muscular Dystrophy Research Agios Dometios Cyprus
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Fondation A De Rothschild Paris France
Ospedale San Raffaele S.r.l. Milan Italy
Quinze-Vingts National Ophthalmology Hospital Paris France
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Turku University Hospital Turku Finland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nice Nice France
Rigshospitalet Copenhagen Denmark
Eginitio Hospital Athens Greece
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Luygj Uvewcxpkgwgv Mqwglcw Chvjson (iilqn Leiden The Netherlands
Mdmyrxfki Iemalejstc Csvvchhv Schfkeou Sui z onaw Warsaw Poland
Cugkeq Hjopwquhjys Udcfjmabzkttb Dd Dnzkq Dijon France
Adhnzp Uzmrgpqaaa Herbpuxm Aarhus Denmark
Hufodzlb Uotmsvalvpofl Dovhuiyn Donostia / San Sebastian Spain
Avucnoj Oqlovyegulx Ptqr Govwrsya Xttnp Bergamo Italy
Hoaoqtgy Voet dmbyapsu Barcelona Spain

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
15.02.2025
Belgium Belgium
Not recruiting
15.02.2025
Cyprus Cyprus
Not recruiting
15.02.2025
Czechia Czechia
Not recruiting
15.02.2025
Denmark Denmark
Not recruiting
15.02.2025
Finland Finland
Not recruiting
15.02.2025
France France
Not recruiting
15.02.2025
Germany Germany
Not recruiting
15.02.2025
Greece Greece
Not recruiting
15.02.2025
Italy Italy
Not recruiting
15.02.2025
Poland Poland
Not recruiting
15.02.2025
Portugal Portugal
Not recruiting
15.02.2025
Spain Spain
Not recruiting
15.02.2025
Sweden Sweden
Not recruiting
15.02.2025
The Netherlands The Netherlands
Not recruiting
15.02.2025

Trial locations

Investigated drugs:

Efgartigimod PH20 SC is a medication being studied for its effectiveness and safety in treating adults with ocular myasthenia gravis, a condition that affects the muscles around the eyes. This medication is administered using a prefilled syringe and is designed to help improve muscle strength and reduce symptoms associated with this condition.

Investigated diseases:

Ocular Myasthenia Gravis – This is a chronic autoimmune disorder that primarily affects the muscles controlling eye and eyelid movement, leading to weakness and fatigue. The condition is characterized by drooping of one or both eyelids (ptosis) and double vision (diplopia), which may fluctuate in severity throughout the day. Symptoms often worsen with activity and improve with rest. Unlike generalized myasthenia gravis, ocular myasthenia gravis does not typically affect other muscle groups. The progression of the disease can vary, with some individuals experiencing stable symptoms, while others may develop generalized myasthenia gravis over time.

Trial ID:
2024-514133-38-00
Protocol code:
ARGX-113-2315
NCT ID:
NCT06558279
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Venetoclax plus drug combination versus drug combination alone in children with relapsed acute myeloid leukemia

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark Finland France +8
  • A study to evaluate the efficacy and safety of depemokimab and salbutamol sulfate in patients with chronic obstructive pulmonary disease and type 2 inflammation.

    Recruiting

    3 1 1
    Belgium Bulgaria Denmark France Germany Greece +6