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
Status: Recruiting
Location: See all (99) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
HonorHealth Neurology - Bob Bové Neuroscience Institute
RECRUITING
Scottsdale
California
Loma Linda University Health
RECRUITING
Loma Linda
USC Roski Eye Institute - Los Angeles
RECRUITING
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Florida
Neurology Offices of South Florida
RECRUITING
Boca Raton
SFM Clinical Research, LLC
RECRUITING
Boca Raton
Neurology Associates PA
RECRUITING
Maitland
University of South Florida
RECRUITING
Tampa
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Henry Ford Health System
RECRUITING
Detroit
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke Neurological Disorders Clinic
RECRUITING
Durham
New Jersey
Robert Wood Johnson Medical School
RECRUITING
New Brunswick
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Martha Morehouse Medical plaza
RECRUITING
Columbus
Pennsylvania
Penn Medicine University City
RECRUITING
Philadelphia
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
Houston Methodist Neurological Institute
RECRUITING
Houston
Other Locations
Australia
Box Hill Hospital
RECRUITING
Box Hill
The Alfred Hospital
RECRUITING
Melbourne
Gold Coast University Hospital
RECRUITING
Southport
Austria
Universitätsklinikum AKH Wien
RECRUITING
Vienna
Belgium
UZ Leuven
RECRUITING
Leuven
Hôpital de la Citadelle
RECRUITING
Liège
Canada
Maritime Neurology
RECRUITING
Halifax
London Health Sciences Centre
RECRUITING
London
Centre Hospitalier de l'Universite de Montreal
RECRUITING
Montreal
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Hopital de L'enfant Jesus
RECRUITING
Québec
Toronto General Hospital
RECRUITING
Toronto
China
Xiangya Hospital Central South University
RECRUITING
Changsha
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guangdong Province Traditional Chinese Medical Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou University Chinese Medicine
RECRUITING
Guangzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University - Xianghu Campus
RECRUITING
Nanchang
Huashan Hospital Fudan University
RECRUITING
Shanghai
Shijiazhuang People's Hospital - Fangbeilu Campus
RECRUITING
Shijiazhuang
Renmin Hospital of Wuhan University - Main Campus
RECRUITING
Wuhan
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Cyprus
Cyprus Institute of Neurology and Genetics
RECRUITING
Égkomi
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus N
Rigshospitalet
RECRUITING
Copenhagen
Finland
Turun Yliopistollinen Keskussairaala
RECRUITING
Turku
France
Hôpital Fondation Adolphe de Rothschild
RECRUITING
Paris
Georgia
LLC Caucasus Medical Centre
RECRUITING
Tbilisi
New Hospitals
RECRUITING
Tbilisi
Petre Sarajishvili Institute of Neurology
RECRUITING
Tbilisi
Pineo Medical Ecosystem
RECRUITING
Tbilisi
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Universität Georg August
RECRUITING
Göttingen
Greece
Eginitio Hospital
RECRUITING
Athens
University General Hospital of Patras
RECRUITING
Pátrai
Italy
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
RECRUITING
Bergamo
IRCCS Istituto dell Scienze Neurologiche di Bologna
RECRUITING
Bologna
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Ospedale San Raffaele S.r.l.
RECRUITING
Milan
AORN Antonio Cardarelli
RECRUITING
Napoli
Azienda Ospedaliero-Universitaria Sant'Andrea
RECRUITING
Roma
Japan
Chiba University Hospital
RECRUITING
Chūōku
Kyushu University Hospital
RECRUITING
Fukuoka
General Hanamaki Hospital
RECRUITING
Hanamaki-shi
Hiroshima University Hospital
RECRUITING
Hiroshima
Saitama Medical Center
RECRUITING
Kawagoe
National Hospital Organization Utano National Hospital
RECRUITING
Kyoto
IUHW Narita Hospital
RECRUITING
Narita
IUHW Narita Hospital
RECRUITING
Narita
National Hospital Organization Hokkaido Medical Center
RECRUITING
Sapporo
Kindai University Hospital
RECRUITING
Sayama
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Osaka University Hospital
RECRUITING
Suita-shi
Netherlands
Leids Universitair Medisch Centrum
RECRUITING
Leiden
Poland
MICS Centrum Medyczne Bydgoszcz
RECRUITING
Bydgoszcz
Centrum Medyczne Neurologia Slaska
RECRUITING
Katowice
Krakowska Akademia Neurologii
RECRUITING
Krakow
SP ZOZ Szpital Uniwersytecki
RECRUITING
Krakow
CLINIREM Sp z o.o.
RECRUITING
Lublin
Portugal
ULS de Santa Maria, EPE - Hospital de Santa Maria
RECRUITING
Lisbon
ULS de Santo António, EPE - Hospital de Santo António
RECRUITING
Porto
Republic of Korea
Kyungpook National University Chilgok hospital
RECRUITING
Daegu
Korea University Anam Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
University Clinical Center Nis
RECRUITING
Niš
Spain
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario de Donostia
RECRUITING
San Sebastián
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
United Kingdom
Royal Sussex County Hospital
RECRUITING
Brighton
Panthera Biopartners - Glasgow
RECRUITING
Glasgow
Leeds General Infirmary
RECRUITING
Leeds
Dementech Neurosciences Clinical Academic Centre
RECRUITING
London
Southampton General Hospital
RECRUITING
Southampton
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-09-18
Estimated Completion Date: 2027-12
Participants
Target number of participants: 124
Treatments
Experimental: Efgartigimod PH20 SC in part A+B
Participants receiving efgartigimod PH20 SC during part A and part B
Experimental: Placebo PH20 SC in Part A + Efgartigimod PH20 SC in Part B
Participants receiving placebo PH20 SC in Part A and Efgartigimod PH20 SC in Part B
Related Therapeutic Areas
Sponsors
Leads: argenx