New drug combo aims to ease muscle weakness in myasthenia gravis

NCT ID NCT07284420

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This study tests whether adding empasiprubart to the existing drug efgartigimod can improve symptoms and daily function in people with generalized myasthenia gravis who still have symptoms on efgartigimod alone. About 70 participants will receive both drugs intravenously. The main goal is to check safety and whether the combination leads to better symptom control.

What this could mean

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

Active substance
empasiprubart and efgartigimod (both given intravenously)
What this could lead to
If successful, this combination could offer better symptom control and quality of life for people with generalized myasthenia gravis who don't respond fully to efgartigimod alone.
What could go wrong
This is an early Phase 2a study with only 70 participants, so results may not apply broadly. Adding a second drug also raises the risk of side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

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

Started

Dec 2025

Expected to finish

Mar 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.

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: * Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab) * Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb * Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration Exclusion Criteria: * Clinical diagnosis of systemic lupus erythematosus (SLE) * Any known complement deficiency * Current administration of a complement inhibitor or received zilucoplan or eculizumab \<2 months or ravulizumab \<6 months before the first study drug administration * Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    27 sites in 8 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

  • AHEPA University General Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, 546 36, Greece

  • AORN Antonio Cardarelli

    RECRUITING

    Naples, 80131, Italy

  • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

    RECRUITING

    Bergamo, Lombardy, 24127, Italy

    Contact Email: •••••@•••••

  • Centrum Medyczne Neurologia Slaska

    RECRUITING

    Katowice, Silesian Voivodeship, 40-689, Poland

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Dent Neurologic Institute - Amherst

    RECRUITING

    Amherst, New York, 14226, United States

  • Duke Early Phase Clinical Research Unit - PPDS

    RECRUITING

    Durham, North Carolina, 27710-0001, United States

  • Eginitio Hospital

    RECRUITING

    Athens, 115 28, Greece

  • Erlanger Health System

    RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, 20133, Italy

    Contact Email: •••••@•••••

  • General Hanamaki Hospital - Kajomachi

    RECRUITING

    Hanamaki, 025-0075, Japan

  • Henry Ford Health Systems

    RECRUITING

    Detroit, Michigan, 48202-2608, United States

  • Hospital Regional Universitario de Malaga - Hospital General

    RECRUITING

    Málaga, Malaga, 29010, Spain

  • Hospital de La Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • IUHW Narita Hospital

    RECRUITING

    Narita, 286-8520, Japan

  • MICS Centrum Medyczne Bydgoszcz

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114-2621, United States

  • National Neuromuscular Research Institute

    RECRUITING

    Austin, Texas, 78756, United States

  • Ohio State Martha Morehouse Outpatient Care

    RECRUITING

    Columbus, Ohio, 43221-3502, United States

  • Profound Research LLC - Carlsbad

    RECRUITING

    Carlsbad, California, 92011, United States

  • UZ Leuven - PPDS

    RECRUITING

    Leuven, 3000, Belgium

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33620, United States

  • University of Texas- San Antonio - Health Science Center - PPDS

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Universitätsklinikum Würzburg

    RECRUITING

    Würzburg, 97080, Germany

  • Universitätsmedizin Göttingen

    RECRUITING

    Göttingen, 37075, Germany

  • Visionary Investigators Network

    RECRUITING

    Miami, Florida, 33176, United States

  • Warszawski Uniwersytet Medyczny

    RECRUITING

    Warsaw, 00-665, Poland

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