New drug combo aims to ease muscle weakness in myasthenia gravis
NCT ID NCT07284420
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
27 sites in 8 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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AHEPA University General Hospital of Thessaloniki
RECRUITINGThessaloniki, 546 36, Greece
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AORN Antonio Cardarelli
RECRUITINGNaples, 80131, Italy
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ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
RECRUITINGBergamo, Lombardy, 24127, Italy
Contact Email: •••••@•••••
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Centrum Medyczne Neurologia Slaska
RECRUITINGKatowice, Silesian Voivodeship, 40-689, Poland
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Charité - Universitätsmedizin Berlin
RECRUITINGBerlin, 10117, Germany
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Dent Neurologic Institute - Amherst
RECRUITINGAmherst, New York, 14226, United States
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Duke Early Phase Clinical Research Unit - PPDS
RECRUITINGDurham, North Carolina, 27710-0001, United States
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Eginitio Hospital
RECRUITINGAthens, 115 28, Greece
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Erlanger Health System
RECRUITINGChattanooga, Tennessee, 37403, United States
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Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITINGMilan, 20133, Italy
Contact Email: •••••@•••••
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General Hanamaki Hospital - Kajomachi
RECRUITINGHanamaki, 025-0075, Japan
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Henry Ford Health Systems
RECRUITINGDetroit, Michigan, 48202-2608, United States
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Hospital Regional Universitario de Malaga - Hospital General
RECRUITINGMálaga, Malaga, 29010, Spain
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Hospital de La Santa Creu i Sant Pau
RECRUITINGBarcelona, 08041, Spain
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IUHW Narita Hospital
RECRUITINGNarita, 286-8520, Japan
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MICS Centrum Medyczne Bydgoszcz
RECRUITINGBydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114-2621, United States
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National Neuromuscular Research Institute
RECRUITINGAustin, Texas, 78756, United States
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Ohio State Martha Morehouse Outpatient Care
RECRUITINGColumbus, Ohio, 43221-3502, United States
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Profound Research LLC - Carlsbad
RECRUITINGCarlsbad, California, 92011, United States
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UZ Leuven - PPDS
RECRUITINGLeuven, 3000, Belgium
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University of South Florida
RECRUITINGTampa, Florida, 33620, United States
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University of Texas- San Antonio - Health Science Center - PPDS
RECRUITINGSan Antonio, Texas, 78229, United States
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Universitätsklinikum Würzburg
RECRUITINGWürzburg, 97080, Germany
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Universitätsmedizin Göttingen
RECRUITINGGöttingen, 37075, Germany
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Visionary Investigators Network
RECRUITINGMiami, Florida, 33176, United States
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Warszawski Uniwersytet Medyczny
RECRUITINGWarsaw, 00-665, Poland
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