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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Myasthenia Gravis, Ocular

In brief

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.

Key facts

Study ID

NCT06558279

Run by

argenx

People needed

141

Starts

2024-09-18

Expected to finish

2027-12-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• HonorHealth Neurology - Bob Bové Neuroscience Institute — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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