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Real-World study tracks Efgartigimod's impact on myasthenia gravis symptoms

NCT ID NCT07595653

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 100 adults in Italy with generalized myasthenia gravis who are starting efgartigimod as part of their routine care. Researchers will track changes in symptoms and daily activities over up to 23 months using patient reports and doctor assessments. The goal is to see how well the drug works in real life, not just in controlled trials.

What this could mean

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

Active substance
efgartigimod alfa
What this could lead to
If successful, this study could show that efgartigimod improves daily functioning and symptom control for people with generalized myasthenia gravis in real-world settings.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It is also limited to Italian patients and a specific antibody type, which may not apply to everyone.

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 100 people

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

Started

Feb 2026

Expected to finish

Jul 2028

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

Adult patients with a documented diagnosis of gMG who are AChR-antibody positive and for whom the decision of treatment with efgartigimod alfa for gMG has been made independently of study participation as part of routine clinical care.

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: * At least 18 years old at signing of informed Consent Form (ICF) and privacy form (PF) * Documented diagnosis of gMG * AChR-antibody positive * The treating physician has decided to initiate efgartigimod alfa as part of routine clinical care and in accordance with product labelling, independently from the study Exclusion Criteria: * Hypersensitivity to the active substance or to any of the excipients listed: sodium dihydrogen phosphate, monohydrate; disodium hydrogen phosphate, anhydrous; arginine hydrochloride; polysorbate 80, hyaluronidase, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 20, sucrose. * Current or planned participation in an interventional clinical trial.

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Get notified about this study

Sign up to get updates when this study changes or when new studies for Generalized myasthenia gravis (GMG) are added.

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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.

Generalized myasthenia gravis (GMG) GMG

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

    30 sites. 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

  • A.O.U. Careggi

    RECRUITING

    Florence, 50134, Italy

    Contact Email: •••••@•••••

  • A.O.U. Consorziale Policlinico

    RECRUITING

    Bari, 70124, Italy

    Contact Email: •••••@•••••

  • A.O.U. Pisana

    RECRUITING

    Pisa, 56124, Italy

    Contact Email: •••••@•••••

  • A.O.U. Policlinico G. Martino

    RECRUITING

    Messina, 98124, Italy

    Contact Email: •••••@•••••

  • A.O.U. Policlinico Universitario

    RECRUITING

    Monserrato, 09042, Italy

    Contact Email: •••••@•••••

  • A.O.U. Renato Dulbecco

    RECRUITING

    Catanzaro, 88100, Italy

    Contact Email: •••••@•••••

  • A.O.U. San Giovanni di Dio e Ruggi D'Aragona

    RECRUITING

    Salerno, 84131, Italy

    Contact Email: •••••@•••••

  • A.O.U. San Luigi Gonzaga

    RECRUITING

    Orbassano, 10043, Italy

    Contact Email: •••••@•••••

  • A.O.U. Sassari

    RECRUITING

    Sassari, 07100, Italy

    Contact Email: •••••@•••••

  • A.O.U. Università della Campania L. Vanvitelli

    RECRUITING

    Naples, 80138, Italy

    Contact Email: •••••@•••••

  • AORN A. Cardarelli

    RECRUITING

    Naples, 80131, Italy

    Contact Email: •••••@•••••

  • AOUI Verona - Policlinico G.B. Rossi

    RECRUITING

    Verona, 37134, Italy

    Contact Email: •••••@•••••

  • ASST GOM Niguarda

    RECRUITING

    Milan, 20162, Italy

    Contact Email: •••••@•••••

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

    Contact Email: •••••@•••••

  • Azienda Ospedale Università Padova

    RECRUITING

    Padova, 35128, Italy

    Contact Email: •••••@•••••

  • Azienda Ospedaliera Perugia

    RECRUITING

    Perugia, 06132, Italy

    Contact Email: •••••@•••••

  • Azienda Ospedaliero Universitaria delle Marche

    RECRUITING

    Ancona, 60126, Italy

    Contact Email: •••••@•••••

  • Fondazione PTV Policlinico Tor Vergata

    RECRUITING

    Roma, 00133, Italy

    Contact Email: •••••@•••••

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

    Contact Email: •••••@•••••

  • IRCCS Cà Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

    Contact Email: •••••@•••••

  • IRCCS Fondazione Casa Sollievo della Sofferenza

    RECRUITING

    San Giovanni Rotondo, 71013, Italy

    Contact Email: •••••@•••••

  • IRCCS Fondazione Mondino

    RECRUITING

    Pavia, 27100, Italy

    Contact Email: •••••@•••••

  • IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, 20133, Italy

    Contact Email: •••••@•••••

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

    Contact Email: •••••@•••••

  • Ospedale Bellaria

    RECRUITING

    Bologna, 40139, Italy

    Contact Email: •••••@•••••

  • Ospedale Ca' Foncello

    RECRUITING

    Treviso, 31100, Italy

    Contact Email: •••••@•••••

  • Ospedale Generale Regionale F. Miulli

    RECRUITING

    Acquaviva delle Fonti, 70021, Italy

    Contact Email: •••••@•••••

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

    Contact Email: •••••@•••••

  • Ospedale Sant'Andrea

    RECRUITING

    Roma, 00189, Italy

    Contact Email: •••••@•••••

  • Ospedale degli Infermi

    RECRUITING

    Rimini, 47923, Italy

    Contact Email: •••••@•••••

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