Study of IMVT-1402 in Adults with Mild to Severe Generalized Myasthenia Gravis

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What is this study about?

This clinical trial focuses on evaluating a new medication called IMVT-1402 for people who have Generalized Myasthenia Gravis, a condition that causes muscle weakness affecting various parts of the body. The weakness typically worsens with activity and improves with rest, making daily activities challenging for those affected.

The study aims to determine how well IMVT-1402 works and how safe it is for patients with mild to severe forms of the disease. The medication is given as a subcutaneous injection, which means it is injected under the skin. Some participants will receive IMVT-1402, while others will receive a placebo during the study.

The treatment period lasts 26 weeks, during which participants will receive regular doses of either IMVT-1402 or placebo. The study will measure how the treatment affects participants’ ability to perform daily activities and their overall muscle strength. Throughout the study, participants will be monitored for any changes in their condition and any potential side effects of the treatment.

1 Initial evaluation

Your condition will be assessed using the Myasthenia Gravis Foundation of America (MGFA) classification system to confirm mild to severe generalized myasthenia gravis

Your daily living activities will be evaluated using the MG-ADL score, which must be 6 or higher

You will need to provide written informed consent after reviewing all study information

2 Treatment assignment

You will be randomly assigned to receive either IMVT-1402 or a placebo (inactive substance)

Neither you nor the study staff will know which treatment you are receiving

The medication will be given as an injection under the skin (subcutaneous injection)

3 Treatment period

You will receive regular subcutaneous injections of either IMVT-1402 or placebo

Your daily activities will be monitored using the MG-ADL score

Your muscle strength will be evaluated using the Quantitative Myasthenia Gravis (QMG) score

4 Monitoring and assessment

Regular evaluations will track changes in your condition

Your progress will be measured by comparing current scores to your initial assessment

The study will monitor if you achieve an MG-ADL score of 0 or 1

The study will track if you achieve 50% or greater improvement in your MG-ADL score

5 Study completion

The study is expected to continue until December 31, 2027

Final assessments will be conducted to evaluate the overall effectiveness of the treatment

Your participation will help determine if IMVT-1402 is effective for treating generalized myasthenia gravis

Who Can Join the Study?

Must be able to understand the study requirements, provide written consent, and follow all study procedures
Must be diagnosed with mild to severe generalized Myasthenia Gravis (gMG) classified as Class II, III, or IV according to the Myasthenia Gravis Foundation of America scale (this scale measures how severe the disease symptoms are)
Must have a score of 6 or higher on the MG-ADL scale (this is a questionnaire that measures how the disease affects daily activities) during both the screening visit and the first day of the study
Must be an adult (18 years or older)
Can be either male or female
Must not be from a vulnerable population group (such as prisoners, mentally disabled persons, or other protected groups)

Who Cannot Join the Study?

Age below 18 years or above 65 years
Previous participation in clinical trials within the last 30 days
Pregnancy or breastfeeding
History of allergic reactions to similar medications
Presence of other autoimmune disorders (conditions where the immune system attacks healthy cells)
Current treatment with immunosuppressive medications (drugs that reduce immune system activity)
Significant heart, liver, or kidney disease
Active infections or recent vaccinations
History of thymoma (tumor of the thymus gland) or previous thymectomy
Uncontrolled high blood pressure or diabetes
Mental conditions that could interfere with following study procedures
Use of medications that could interact with the study drug
Unable to provide informed consent
History of substance abuse in the past 5 years
Abnormal laboratory test results that could indicate other health issues

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Universitaetsmedizin Goettingen	Goettingen	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Neurologia Slaska Centrum Medyczne	Katowice	Poland
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Kistarcsai Flor Ferenc Korhaz	Kistarcsa	Hungary
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Semmelweis University	Budapest	Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
General University Hospital Of Patras	Patras	Greece
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet	Budapest	Hungary
Rigshospitalet	Copenhagen	Denmark
Eginitio Hospital	Athens	Greece
Klinikum Wuerzburg Mitte gGmbH	Wuerzburg	Germany
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
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Centrum Medyczne HOPE Clinic Sebastian Szklener	Lublin	Poland
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Uqlfwrulzrxtzucwnkmmi Ehcon Awm	Essen	Germany
Byuelhzh Cxtgoc Stllsy	Constanta	Romania
Mngrlixhh i Pnuzrzpev Lhyqgup Skeftc Pizxpdobarh	Cracow	Poland
Uykqswgyyfqqtc Cfpwmip Kqykhgkdn	Gdansk	Poland
Hcuyndvi Dx Li Stujc Cezt I Sziq Ppb	Barcelona	Spain
Alnyylz Oivvnkweagb Pnpk Gsbcipik Xoygn	Bergamo	Italy
Mvclhhrotk swnuug	Brno	Czechia
Chzwjus Mbwcdli Da Dkvmyylsfr Sa Tqnwitxwp Aydunekan Nbhjfc Sjrrci	Brasov	Romania

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	13.10.2025
Denmark	Recruiting	13.10.2025
Germany	Recruiting	13.10.2025
Greece	Recruiting	13.10.2025
Hungary	Recruiting	13.10.2025
Italy	Recruiting	13.10.2025
Poland	Recruiting	13.10.2025
Romania	Recruiting	13.10.2025
Spain	Recruiting	13.10.2025

Trial locations

Investigated drugs:

IMEROPRUBART

IMVT-1402 is an investigational medication being studied for the treatment of generalized myasthenia gravis, which is an autoimmune disorder that causes muscle weakness. This medication aims to reduce the severity of symptoms in patients with mild to severe forms of the disease by targeting the underlying immune system mechanisms that cause muscle weakness.

Placebo is an inactive substance that contains no medication. It is used as a comparison to measure the true effects of the active medication being tested in the study.

Investigated diseases:

Myasthenia gravis

Generalized Myasthenia Gravis – A rare autoimmune disorder that causes muscle weakness throughout the body. The condition occurs when the immune system mistakenly attacks the connection between nerves and muscles, specifically targeting the acetylcholine receptors at the neuromuscular junction. This interference disrupts the normal communication between nerves and muscles, leading to muscle fatigue and weakness that typically worsens with activity and improves with rest. The weakness can affect multiple muscle groups, including those controlling eye movements, facial expressions, chewing, swallowing, speaking, and limb movements. The symptoms often fluctuate, with periods of greater and lesser severity.

Trial ID:

2024-515979-35-00

Protocol code:

IMVT-1402-3101

NCT ID:

NCT07039916

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of IMVT-1402 in Adults with Mild to Severe Generalized Myasthenia Gravis

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