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
- Diseases
- Myasthenia gravis
- 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
Sites (105)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mediclinic Parkview Coordinator of this site? Confirm its status | Dubai | United Arab Emirates | Unknown status |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| Maritime Neurology Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Ottawa Hospital Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Hopital de L'enfant Jesus Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital of Guangzhou University Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Province Traditional Chinese Medical Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First affiliated hospital of Nanchang University (Xianghu campus) Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shijiazhuang People's Hospital - Fangbeilu Campus Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Renmin Hospital of Wuhan University - Main Campus Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The Cyprus Foundation For Muscular Dystrophy Research Coordinator of this site? Confirm its status | Agios Dometios | Cyprus | Completed |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Nemocnice Pardubickeho kraje a.s. Coordinator of this site? Confirm its status | Pardubice | Czechia | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Active, not recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Fondation A. de Rothschild Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Quinze-Vingts National Ophthalmology Hospital Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Royal Sussex County Hospital Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Panthera Biopartners - Glasgow Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Leeds General Infirmary Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Dementech Neurosciences Clinical Academic Centre Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| LLC "Caucasus Medical Centre" Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Petre Sarajishvili Institute of Neurology Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| New Hospitals Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Pineo Medical Ecosystem Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Eginitio Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Chiba University Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| General Hanamaki Hospital Coordinator of this site? Confirm its status | Hanamaki-shi | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Saitama Medical Center Coordinator of this site? Confirm its status | Kawagoe | Japan | Unknown status |
| National Hospital Organization Utano National Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| IUHW Narita Hospital Coordinator of this site? Confirm its status | Narita | Japan | Unknown status |
| National Hospital Organization Hokkaido Medical Center Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Sayama | Japan | Unknown status |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Active, not recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Krakowska Akademia Neurologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Neurologia Śląska Centrum Medyczne Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Clinirem Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
| University Clinical Center of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University Clinical Center NIS Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Completed |
| National Neuromuscular Research Institute Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Neurology Offices of South Florida Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| SFM Clinical Research LLC Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University of California Irvine Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Martha Morehouse Medical Plaza Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke Neurological Disorders Clinic Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Houston Methodist Neurological Institute Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Loma Linda University Health Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| USC Roski Eye Institute - Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Neurology Associates PA Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Robert Wood Johnson Medical School Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Penn Medicine University City Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| HonorHealth Neurology - Bob Bové Neuroscience Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.