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ACTIVE NOT RECRUITING
NCT06558279
PHASE3

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

Sponsor: argenx

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

141

Start Date

2024-09-18

Completion Date

2027-12

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Efgartigimod PH20 SC

Subcutaneous efgartigimod PH20 SC given by prefilled syringe

OTHER

Placebo PH20 SC

Subcutaneous placebo PH20 SC given by prefilled syringe

Locations (102)

HonorHealth Neurology - Bob Bové Neuroscience Institute

Scottsdale, Arizona, United States

Loma Linda University Health

Loma Linda, California, United States

USC Roski Eye Institute - Los Angeles

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Neurology Offices of South Florida

Boca Raton, Florida, United States

SFM Clinical Research, LLC

Boca Raton, Florida, United States

Neurology Associates PA

Maitland, Florida, United States

University of South Florida

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of California Irvine

Columbia, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke Neurological Disorders Clinic

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Martha Morehouse Medical plaza

Columbus, Ohio, United States

Penn Medicine University City

Philadelphia, Pennsylvania, United States

National Neuromuscular Research Institute

Austin, Texas, United States

Houston Methodist Neurological Institute

Houston, Texas, United States

Box Hill Hospital

Box Hill, Australia

The Alfred Hospital

Melbourne, Australia

Gold Coast University Hospital

Southport, Australia

Universitätsklinikum AKH Wien

Vienna, Austria

UZ Leuven

Leuven, Belgium

Hôpital de la Citadelle

Liège, Belgium

Maritime Neurology

Halifax, Canada

London Health Sciences Centre

London, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Canada

Ottawa Hospital Research Institute

Ottawa, Canada

Hopital de L'enfant Jesus

Québec, Canada

Toronto General Hospital

Toronto, Canada

Xiangya Hospital Central South University

Changsha, China

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

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Fujian Medical University Union Hospital

Fuzhou, China

Guangdong Province Traditional Chinese Medical Hospital

Guangzhou, China

The First Affiliated Hospital of Guangzhou University Chinese Medicine

Guangzhou, China

Qilu Hospital of Shandong University

Jinan, China

The First Affiliated Hospital of Nanchang University - Xianghu Campus

Nanchang, China

Huashan Hospital Fudan University

Shanghai, China

Shijiazhuang People's Hospital - Fangbeilu Campus

Shijiazhuang, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Renmin Hospital of Wuhan University - Main Campus

Wuhan, China

Cyprus Institute of Neurology and Genetics

Égkomi, Cyprus

Fakultni nemocnice Brno

Brno, Czechia

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

Pardubice, Czechia

Aarhus Universitetshospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark

Turun Yliopistollinen Keskussairaala

Turku, Finland

Hôpital Fondation Adolphe de Rothschild

Paris, France

Petre Sarajishvili Institute of Neurology

Tbilisi, Georgia

New Hospitals

Tbilisi, Georgia

Pineo Medical Ecosystem

Tbilisi, Georgia

LLC Caucasus Medical Centre

Tbilisi, Georgia

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universität Georg August

Göttingen, Germany

Eginitio Hospital

Athens, Greece

University General Hospital of Patras

Pátrai, Greece

ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

Bergamo, Italy

IRCCS Istituto dell Scienze Neurologiche di Bologna

Bologna, Italy

Ospedale San Raffaele S.r.l.

Milan, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

AORN Antonio Cardarelli

Naples, Italy

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, Italy

Chiba University Hospital

Chūōku, Japan

Kyushu University Hospital

Fukuoka, Japan

General Hanamaki Hospital

Hanamaki-shi, Japan

Hiroshima University Hospital

Hiroshima, Japan

Saitama Medical Center

Kawagoe, Japan

National Hospital Organization Utano National Hospital

Kyoto, Japan

IUHW Narita Hospital

Narita, Japan

National Hospital Organization Hokkaido Medical Center

Sapporo, Japan

Kindai University Hospital

Sayama, Japan

Tokyo Medical University Hospital

Shinjuku-Ku, Japan

Osaka University Hospital

Suita-Shi, Japan

Leids Universitair Medisch Centrum

Leiden, Netherlands

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Centrum Medyczne Neurologia Slaska

Katowice, Poland

SP ZOZ Szpital Uniwersytecki

Krakow, Poland

Krakowska Akademia Neurologii

Krakow, Poland

CLINIREM Sp z o.o.

Lublin, Poland

ULS de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal

ULS de Santo António, EPE - Hospital de Santo António

Porto, Portugal

University Clinical Center of Serbia

Belgrade, Serbia

University Clinical Center Nis

Niš, Serbia

Kyungpook National University Chilgok hospital

Daegu, South Korea

Korea University Anam Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario de Donostia

San Sebastián, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Mediclinic Parkview

Dubai, United Arab Emirates

Royal Sussex County Hospital

Brighton, United Kingdom

Panthera Biopartners - Glasgow

Glasgow, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

Dementech Neurosciences Clinical Academic Centre

London, United Kingdom

Southampton General Hospital

Southampton, United Kingdom