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New dosing strategy for myasthenia gravis drug shows promise

NCT ID NCT04980495

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two different ways of giving the drug efgartigimod to people with generalized myasthenia gravis, a condition that causes muscle weakness. One group received the drug continuously, while the other got it in cycles. The goal was to see which schedule works better to control symptoms and improve daily activities. The study involved 69 adults and lasted up to 138 weeks.

What this could mean

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

Active substance
efgartigimod (a drug given by IV infusion)
What this could lead to
If successful, this study could help doctors find the best dosing schedule to control symptoms of generalized myasthenia gravis more effectively.
What could go wrong
This is a completed phase 3b study, but it is small (69 participants) and open-label, so results may not apply to all patients. The drug may still cause side effects or not work for 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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

69 people

The number who actually took part.

Started

Dec 2021

Finished

Oct 2025

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.

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 of age, at the time of signing the informed consent. * Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti-acetylcholine receptor antibodies (AChR-Abs). * Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, or IV Exclusion Criteria: * Any other condition that, in the opinion of the investigator, would interfere with an accurate assessment of the clinical symptoms of gMG and/or put the participant at undue risk * A thymectomy within 3 months of screening * Use of the following prior or concomitant therapies: 1. intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) within 14 days of day 1 2. Rituximab within 6 months of day 1 3. Eculizumab within 1 month of day 1 4. Other monoclonal antibodies (eg, adalimumab, tocilizumab, ixekizumab)

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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 MG - myasthenia gravis

Contacts and locations

Locations

  • Investigator Site 1 - GEO9950001

    Tbilisi, 0114, Georgia

  • Investigator Site 10 - US0010007

    Carlsbad, California, 92011, United States

  • Investigator Site 11 - US0010011

    Austin, Texas, 78756, United States

  • Investigator Site 12 - US0010004

    Kansas City, Kansas, 66160, United States

  • Investigator Site 13 - US0010013

    Portland, Oregon, 97239, United States

  • Investigator Site 14 - US0010010

    Richmond, Virginia, 23219, United States

  • Investigator Site 15 - US0010014

    Coral Springs, Florida, 33067, United States

  • Investigator Site 16 - US0010009

    Augusta, Georgia, 30910, United States

  • Investigator Site 17 - US0010012

    Philadelphia, Pennsylvania, 19104, United States

  • Investigator Site 18 - ES0340002

    Santiago de Compostela, A Coruña, 15706, Spain

  • Investigator Site 19 - ES0340001

    Barcelona, 08041, Spain

  • Investigator Site 2 - GEO9950002

    Tbilisi, 0112, Georgia

  • Investigator Site 20 - FR0330001

    Marseille, 13385, France

  • Investigator Site 21 - IT0390002

    Milan, 20133, Italy

  • Investigator Site 22 - IT0390001

    Roma, 00168, Italy

  • Investigator Site 23 - FR0330005

    Bordeaux, 33604, France

  • Investigator Site 24 - FR0330004

    Lille, 59000, France

  • Investigator Site 25 - FR0330003

    Nice, 06001, France

  • Investigator Site 26 - AT0430002

    Innsbruck, 6020, Austria

  • Investigator Site 27 - AT0430001

    Vienna, 1090, Austria

  • Investigator Site 28 - BE0320001

    Leuven, 3000, Belgium

  • Investigator Site 29 - CA0019003

    London, N6A 5A5, Canada

  • Investigator Site 3 - GEO9950003

    Tbilisi, 0114, Georgia

  • Investigator Site 30 - IT0390004

    Genova, 16132, Italy

  • Investigator Site 31 - IT0390005

    Bologna, 40139, Italy

  • Investigator Site 32 - DE0490001

    Essen, 45147, Germany

  • Investigator Site 33 - DE0490004

    Berlin, 10117, Germany

  • Investigator Site 34 - DE0490005

    Hanover, 30625, Germany

  • Investigator Site 35 - NL0310001

    Amsterdam, 1105, Netherlands

  • Investigator Site 36 - DE0490002

    Bochum, 44791, Germany

  • Investigator Site 4 - PL0480001

    Lubin, 20-093, Poland

  • Investigator Site 5 - PL0480002

    Krakow, 31-426, Poland

  • Investigator Site 6 - US0010008

    Meadows, Illinois, 60008, United States

  • Investigator Site 7 - US0010001

    Orange, California, 92868, United States

  • Investigator Site 8 - US0010003

    Chicago, Illinois, 60611, United States

  • Investigator Site 9 - 0010006

    Boca Raton, Florida, 33487, United States

  • Investigator site 37 - CA0019002

    Québec, H3A 2B4, Canada

  • Investigator site 38 - FR0330002

    Paris, 75013, France

  • Investigator site 39 - IT0390006

    Pisa, 56126, Italy

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