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New shot could ease droopy eyelids in rare muscle disease

NCT ID NCT06558279

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 1 time

Summary

This study tests a drug called efgartigimod for adults with ocular myasthenia gravis, a condition that causes eye muscle weakness like droopy eyelids or double vision. About 141 people will receive either the drug or a placebo for 7 weeks, then everyone gets the drug for up to 2 years. The goal is to see if it improves symptoms safely.

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

141 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Dec 2027

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 at least 18 years of age and the local legal age of consent for clinical studies * Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy" * Is MGFA Class I (any ocular muscle weakness) * Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2 Exclusion Criteria: * Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia * Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk

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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, ocular

Contacts and locations

Locations

  • AORN Antonio Cardarelli

    Naples, 80131, Italy

  • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Roma, 00189, Italy

  • Box Hill Hospital

    Box Hill, 3128, Australia

  • CLINIREM Sp z o.o.

    Lublin, 20-064, Poland

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, H2X 0A9, Canada

  • Centrum Medyczne Neurologia Slaska

    Katowice, 40-689, Poland

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • Chiba University Hospital

    Chūōku, 260-8677, Japan

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cyprus Institute of Neurology and Genetics

    Égkomi, 2371, Cyprus

  • Dementech Neurosciences Clinical Academic Centre

    London, W1G 9ST, United Kingdom

  • Duke Neurological Disorders Clinic

    Durham, North Carolina, 27710, United States

  • Eginitio Hospital

    Athens, 115 28, Greece

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • General Hanamaki Hospital

    Hanamaki-shi, 025-0075, Japan

  • Gold Coast University Hospital

    Southport, 4215, Australia

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou, 510120, China

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • HonorHealth Neurology - Bob Bové Neuroscience Institute

    Scottsdale, Arizona, 85251, United States

  • Hopital de L'enfant Jesus

    Québec, G1J 1Z4, Canada

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28304, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de Donostia

    San Sebastián, 20014, Spain

  • Hospital del Mar

    Barcelona, 8003, Spain

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030, United States

  • Huashan Hospital Fudan University

    Shanghai, 200040, China

  • Hôpital Fondation Adolphe de Rothschild

    Paris, 75019, France

  • Hôpital de la Citadelle

    Liège, 4000, Belgium

  • IRCCS Istituto dell Scienze Neurologiche di Bologna

    Bologna, 40139, Italy

  • IUHW Narita Hospital

    Narita, 286-8520, Japan

  • Kindai University Hospital

    Sayama, 589-8511, Japan

  • Korea University Anam Hospital

    Seoul, 2841, South Korea

  • Krakowska Akademia Neurologii

    Krakow, 31-505, Poland

  • Kyungpook National University Chilgok hospital

    Daegu, 41404, South Korea

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • LLC Caucasus Medical Centre

    Tbilisi, 186, Georgia

  • Leeds General Infirmary

    Leeds, LS1 3EX, United Kingdom

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • Loma Linda University Health

    Loma Linda, California, 92354, United States

  • London Health Sciences Centre

    London, N6A 5A5, Canada

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065, Poland

  • Maritime Neurology

    Halifax, B3R 1V9, Canada

  • Martha Morehouse Medical plaza

    Columbus, Ohio, 43221, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mediclinic Parkview

    Dubai, 51122, United Arab Emirates

  • National Hospital Organization Hokkaido Medical Center

    Sapporo, 063-0005, Japan

  • National Hospital Organization Utano National Hospital

    Kyoto, 616-8255, Japan

  • National Neuromuscular Research Institute

    Austin, Texas, 78759-8402, United States

  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

    Pardubice, 532 03, Czechia

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428-4221, United States

  • New Hospitals

    Tbilisi, 114, Georgia

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Osaka University Hospital

    Suita-Shi, 565-0871, Japan

  • Ospedale San Raffaele S.r.l.

    Milan, 20132, Italy

  • Ottawa Hospital Research Institute

    Ottawa, K1Y 4E9, Canada

  • Panthera Biopartners - Glasgow

    Glasgow, G51 4TY, United Kingdom

  • Penn Medicine University City

    Philadelphia, Pennsylvania, 19104, United States

  • Petre Sarajishvili Institute of Neurology

    Tbilisi, 112, Georgia

  • Pineo Medical Ecosystem

    Tbilisi, 114, Georgia

  • Qilu Hospital of Shandong University

    Jinan, 250012, China

  • Renmin Hospital of Wuhan University - Main Campus

    Wuhan, 430060, China

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • Royal Sussex County Hospital

    Brighton, BN2 5BE, United Kingdom

  • SFM Clinical Research, LLC

    Boca Raton, Florida, 33487-2768, United States

  • SP ZOZ Szpital Uniwersytecki

    Krakow, 31-503, Poland

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45, Sweden

  • Saitama Medical Center

    Kawagoe, 350-0844, Japan

  • Severance Hospital Yonsei University Health System

    Seoul, 3722, South Korea

  • Shijiazhuang People's Hospital - Fangbeilu Campus

    Shijiazhuang, 050011, China

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • The Alfred Hospital

    Melbourne, 3004, Australia

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016, China

  • The First Affiliated Hospital of Guangzhou University Chinese Medicine

    Guangzhou, 510405, China

  • The First Affiliated Hospital of Nanchang University - Xianghu Campus

    Nanchang, 330000, China

  • Tokyo Medical University Hospital

    Shinjuku-Ku, 160-0023, Japan

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030, China

  • Toronto General Hospital

    Toronto, M5G 2C4, Canada

  • Turun Yliopistollinen Keskussairaala

    Turku, 20521, Finland

  • ULS de Santa Maria, EPE - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • ULS de Santo António, EPE - Hospital de Santo António

    Porto, 4099-001, Portugal

  • USC Roski Eye Institute - Los Angeles

    Los Angeles, California, 90033, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Clinical Center Nis

    Niš, 18 000, Serbia

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • University General Hospital of Patras

    Pátrai, 265 04, Greece

  • University of California Irvine

    Columbia, Maryland, 21044, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of South Florida

    Tampa, Florida, 33620, United States

  • Universität Georg August

    Göttingen, 37075, Germany

  • Universitätsklinikum AKH Wien

    Vienna, 1090, Austria

  • Xiangya Hospital Central South University

    Changsha, 410008, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.