Study on Nipocalimab 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, a disease that causes muscle weakness. The study is testing a treatment called nipocalimab, which is given as an infusion, meaning it is delivered directly into the bloodstream through a vein. The trial will compare the effects of nipocalimab to a placebo, which is a substance with no active medication, to see how well it works and how safe it is for people with this condition.

The main goal of the study is to evaluate how effective nipocalimab is in improving the daily living activities of people with Generalized Myasthenia Gravis. Participants in the study will receive either nipocalimab or a placebo, and their progress will be monitored over a period of time. The study will look at changes in their ability to perform daily activities and any side effects they might experience.

Participants will be randomly assigned to receive either the treatment or the placebo, and neither the participants nor the researchers will know who is receiving which, to ensure unbiased results. The study will take place over several weeks, and participants will have regular check-ups to assess their health and the effects of the treatment. The information gathered from this study will help determine if nipocalimab is a safe and effective treatment option for people with Generalized Myasthenia Gravis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A blood test is performed to ensure the presence of specific antibodies related to generalized myasthenia gravis.

2 randomization

Participants are randomly assigned to receive either the study medication, nipocalimab, or a placebo, which is a saline solution.

This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment phase

The treatment involves intravenous infusions of nipocalimab or placebo.

Infusions are administered according to a schedule determined by the study protocol, typically over a period of several weeks.

4 monitoring and assessments

Regular monitoring is conducted to assess the participant’s response to the treatment. This includes evaluating changes in symptoms using the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale.

Blood samples are collected periodically to monitor safety and measure the levels of the study medication in the body.

5 end of treatment evaluation

At the end of the treatment phase, a comprehensive evaluation is performed to assess the overall effectiveness and safety of the treatment.

Participants may be asked to complete questionnaires and undergo additional medical examinations.

6 follow-up

After completing the treatment phase, participants enter a follow-up period where their health and any long-term effects of the treatment are monitored.

This phase may involve periodic visits to the study site for assessments and discussions with the study team.

Who Can Join the Study?

Must be at least 18 years old at the time of giving consent.
Women who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control methods during the study and for 30 days after the last dose.
Women must agree not to donate eggs during the study and for 30 days after the last dose.
Men must use condoms during the study and for 90 days after the last dose. If their partner can have children, they are encouraged to use effective birth control methods.
Men must agree not to donate sperm during the study and for 90 days after the last dose.
Must sign a form indicating understanding of the study and willingness to participate and follow all procedures.
Must be able to read and write.
Must have a diagnosis of Generalized Myasthenia Gravis with muscle weakness and a positive test for specific antibodies related to the condition.
Must have a score of 6 or higher on a specific scale used to measure daily living activities affected by Myasthenia Gravis.
Must have a less than ideal response to current stable treatment for Generalized Myasthenia Gravis.
Can use herbal or alternative remedies if approved by the study doctor, but must keep the dose and schedule stable during the study.
If the spleen has been removed, must be at least 3 months post-surgery and vaccinated according to guidelines.
Must have good vein access for receiving the study drug and taking blood samples.
Recommended to be up to date on all vaccinations, including COVID-19, at least 2 weeks before study visits.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Generalized Myasthenia Gravis. This is a condition that affects the muscles, making them weak and tired.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study instructions or take the treatment as directed.
Patients who are part of a vulnerable population that the study cannot safely include.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Universitaetsmedizin Goettingen	Goettingen	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Neurologia Slaska Centrum Medyczne	Katowice	Poland
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Centre Hospitalier Universitaire De Nice	Nice	France
Neurocentrum Bydgoszcz Sp. z o.o.	Bydgoszcz	Poland
Rigshospitalet	Copenhagen	Denmark
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Hospital General Universitario De Alicante	Alicante	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Karolinska University Hospital	Solna	Sweden
Aalborg University Hospital	Aalborg	Denmark
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Charite Research Organisation GmbH	Berlin	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Universita Degli Studi Di Brescia	Brescia	Italy
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Hospital Universitario Basurto	Bilbao	Spain
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Neuroprotect Sp. z o.o.	Warsaw	Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Neurologie and Rehabilitace	Brno	Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Clinirem Sp. z o.o.	Lublin	Poland
Cstquwcgg Umkslfiaksfybs Svpklznpy	Woluwe-Saint-Lambert	Belgium
Hinrlrgv Dh Li Sgcef Cqon I Saqp Prn	Barcelona	Spain
Hjbbrbdx Vmcg dkhmvxla	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	22.10.2021
Czechia	Recruiting	22.10.2021
Denmark	Not recruiting	22.10.2021
France	Recruiting	22.10.2021
Germany	Recruiting	22.10.2021
Italy	Recruiting	22.10.2021
Poland	Recruiting	22.10.2021
Spain	Recruiting	22.10.2021
Sweden	Recruiting	22.10.2021

Trial locations

Investigated drugs:

Nipocalimab

Nipocalimab is a medication being studied for its effectiveness in treating adults with generalized myasthenia gravis, a condition that causes muscle weakness. The trial aims to see how well nipocalimab works in improving the daily living activities of people with this condition. The study also looks at the safety of the medication and how it behaves in the body.

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 body’s own tissues, specifically targeting the receptors that receive nerve signals. 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 and quality of life.

Trial ID:

2023-504152-97-00

Protocol code:

MOM-M281-011

NCT ID:

NCT04951622

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Nipocalimab for Adults with Generalized Myasthenia Gravis

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