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New study tracks safety of efgartigimod for muscle weakness disease

NCT ID NCT06298565

Knowledge-focused Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 680 people with generalized myasthenia gravis to see how safe efgartigimod is over the long term. Some participants take the drug, while others do not. Researchers will compare rates of serious infections and other side effects between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efgartigimod
What this could lead to
If successful, this study could confirm that efgartigimod is safe for long-term use in generalized myasthenia gravis.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences between patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 680 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients diagnosed with gMG

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment * Have provided appropriate written informed consent Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myasthenia gravis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    35 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Azienda Ospedaliera di Rilievo Nazionale Cardarelli

    RECRUITING

    Naples, 80131, Italy

    Contact Email: •••••@•••••

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

    Contact Email: •••••@•••••

  • BCN Research, LLC - Gamma Therapeutic Center

    RECRUITING

    Greenfield, Wisconsin, 53228, United States

    Contact Email: •••••@•••••

  • BayCare Health System, Inc. St Anthony's Hospital

    RECRUITING

    St. Petersburg, Florida, 33705, United States

    Contact Email: •••••@•••••

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact Email: •••••@•••••

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

    Contact Email: •••••@•••••

  • Georg-August-Universität Göttingen

    RECRUITING

    Göttingen, 37073, Germany

    Contact Email: •••••@•••••

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Hospital Clinico Universitario San Carlos

    RECRUITING

    Madrid, 28040, Spain

    Contact Email: •••••@•••••

  • Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia

    RECRUITING

    Barcelona, 08035, Spain

    Contact Email: •••••@•••••

  • Hospital Universitari de Bellvitge

    RECRUITING

    Barcelona, 08907, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

    Contact Email: •••••@•••••

  • Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III

    RECRUITING

    Linz, 4021, Austria

    Contact Email: •••••@•••••

  • Klinikum Altenburger Land GmbH

    RECRUITING

    Altenburg, 04600, Germany

    Contact Email: •••••@•••••

  • Klinikum Christophsbad

    RECRUITING

    Göppingen, 7303, Germany

    Contact Email: •••••@•••••

  • Klinikum Oberberg

    RECRUITING

    Gummersbach, 51643, Germany

    Contact Email: •••••@•••••

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

    Contact Email: •••••@•••••

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

    Contact Email: •••••@•••••

  • Medsol Clinical Research Center Inc

    RECRUITING

    Port Charlotte, Florida, 33952, United States

    Contact Email: •••••@•••••

  • National Neuromuscular Research Institute

    RECRUITING

    Austin, Texas, 78759, United States

    Contact Email: •••••@•••••

  • Norton Neuroscience Institute

    RECRUITING

    Louisville, Kentucky, 40241, United States

    Contact Email: •••••@•••••

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Ospedale Bellaria - Clinica Neurologica

    RECRUITING

    Bologna, 40139, Italy

    Contact Email: •••••@•••••

  • Piazza OMS - Organizzazione Mondiale della Sanità

    RECRUITING

    Bergamo, 24127, Italy

    Contact Email: •••••@•••••

  • Prairie Education and Research Cooperative and HSHS Medical Group

    RECRUITING

    O'Fallon, Illinois, 62701, United States

    Contact Email: •••••@•••••

  • SFM Clinical Research, LLC

    RECRUITING

    Boca Raton, Florida, 33487, United States

    Contact Email: •••••@•••••

  • St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum

    RECRUITING

    Bochum, 44791, Germany

    Contact Email: •••••@•••••

  • UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Email: •••••@•••••

  • UZ Leuven (University Hospitals Leuven)

    RECRUITING

    Leuven, 3000, Belgium

    Contact Email: •••••@•••••

  • University of Colorado Hospital

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • University of Florida College of Medicine Jacksonville

    RECRUITING

    Jacksonville Beach, Florida, 32209, United States

    Contact Email: •••••@•••••

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

    Contact Email: •••••@•••••

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

    Contact Email: •••••@•••••

  • Universitätsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

    Contact Email: •••••@•••••

  • Universitätsklinikum Würzburg

    RECRUITING

    Würzburg, 97080, Germany

    Contact Email: •••••@•••••

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