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NCT06558279Active, not recruitingPhase 3

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis

Source: ClinicalTrials.gov · Last updated 2 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
141 (actual)
First submitted
14 Aug 2024
Start date
Sept 2024
Primary completion date
Jan 2026
Lead sponsor
argenx
NCT number
NCT06558279
EU CT number
2024-514133-38-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 141
  • From Sept 2024 to the primary completion date, Jan 2026
  • 105 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (105)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mediclinic Parkview
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DubaiUnited Arab EmiratesUnknown status
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Box Hill Hospital
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Box HillAustraliaUnknown status
The Alfred Hospital
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MelbourneAustraliaUnknown status
Gold Coast University Hospital
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SouthportAustraliaUnknown status
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumActive, not recruiting
Maritime Neurology
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HalifaxCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaUnknown status
Ottawa Hospital Research Institute
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OttawaCanadaUnknown status
Hopital de L'enfant Jesus
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QuébecCanadaUnknown status
Toronto General Hospital
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TorontoCanadaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital
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ChengduChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
The First Affiliated Hospital of Guangzhou University Chinese Medicine
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GuangzhouChinaUnknown status
Guangdong Province Traditional Chinese Medical Hospital
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GuangzhouChinaUnknown status
Qilu Hospital of Shandong University
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JinanChinaUnknown status
The First affiliated hospital of Nanchang University (Xianghu campus)
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NanchangChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Shijiazhuang People's Hospital - Fangbeilu Campus
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ShijiazhuangChinaUnknown status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Renmin Hospital of Wuhan University - Main Campus
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WuhanChinaUnknown status
The Cyprus Foundation For Muscular Dystrophy Research
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Agios DometiosCyprusCompleted
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Nemocnice Pardubickeho kraje a.s.
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PardubiceCzechiaActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyActive, not recruiting
Aarhus University Hospital
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Hospital Universitario Donostia
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DonostiaSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Turku University Hospital
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TurkuFinlandCompleted
Centre Hospitalier Universitaire de Dijon
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DijonFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Fondation A. de Rothschild
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ParisFranceActive, not recruiting
Quinze-Vingts National Ophthalmology Hospital
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ParisFranceActive, not recruiting
Royal Sussex County Hospital
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BrightonUnited KingdomUnknown status
Panthera Biopartners - Glasgow
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GlasgowUnited KingdomUnknown status
Leeds General Infirmary
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LeedsUnited KingdomUnknown status
Dementech Neurosciences Clinical Academic Centre
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LondonUnited KingdomUnknown status
Southampton General Hospital
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SouthamptonUnited KingdomUnknown status
LLC "Caucasus Medical Centre"
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TbilisiGeorgiaUnknown status
Petre Sarajishvili Institute of Neurology
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TbilisiGeorgiaUnknown status
New Hospitals
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TbilisiGeorgiaUnknown status
Pineo Medical Ecosystem
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TbilisiGeorgiaUnknown status
Eginitio Hospital
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AthensGreeceActive, not recruiting
General University Hospital Of Patras
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PatrasGreeceActive, not recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyActive, not recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyActive, not recruiting
Chiba University Hospital
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ChūōkuJapanUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
General Hanamaki Hospital
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Hanamaki-shiJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Saitama Medical Center
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KawagoeJapanUnknown status
National Hospital Organization Utano National Hospital
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KyotoJapanUnknown status
IUHW Narita Hospital
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NaritaJapanUnknown status
National Hospital Organization Hokkaido Medical Center
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SapporoJapanUnknown status
Kindai University Hospital
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SayamaJapanUnknown status
Tokyo Medical University Hospital
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Shinjuku-kuJapanUnknown status
Osaka University Hospital
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Suita-shiJapanUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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BydgoszczPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandActive, not recruiting
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandActive, not recruiting
Neurologia Śląska Centrum Medyczne
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KatowicePolandActive, not recruiting
Clinirem Sp. z o.o.
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LublinPolandActive, not recruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalCompleted
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalCompleted
University Clinical Center of Serbia
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BelgradeSerbiaUnknown status
University Clinical Center NIS
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NišSerbiaUnknown status
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenCompleted
National Neuromuscular Research Institute
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AustinUnited StatesUnknown status
Neurology Offices of South Florida
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Boca RatonUnited StatesUnknown status
SFM Clinical Research LLC
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Boca RatonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
Northwestern Memorial Hospital
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
University of California Irvine
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ColumbiaUnited StatesUnknown status
Martha Morehouse Medical Plaza
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ColumbusUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Duke Neurological Disorders Clinic
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DurhamUnited StatesUnknown status
Houston Methodist Neurological Institute
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HoustonUnited StatesUnknown status
Loma Linda University Health
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Loma LindaUnited StatesUnknown status
USC Roski Eye Institute - Los Angeles
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Los AngelesUnited StatesUnknown status
Neurology Associates PA
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MaitlandUnited StatesUnknown status
Robert Wood Johnson Medical School
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New BrunswickUnited StatesUnknown status
Penn Medicine University City
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PhiladelphiaUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
HonorHealth Neurology - Bob Bové Neuroscience Institute
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ScottsdaleUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.