Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis
Lead Sponsor:
argenx
Conditions:
Myasthenia Gravis, Ocular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT06558279
Start Date
September 18 2024
End Date
December 1 2027
Last Update
December 15 2025
Active Locations (102)
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1
HonorHealth Neurology - Bob Bové Neuroscience Institute
Scottsdale, Arizona, United States, 85251
2
Loma Linda University Health
Loma Linda, California, United States, 92354
3
USC Roski Eye Institute - Los Angeles
Los Angeles, California, United States, 90033
4
University of California San Francisco
San Francisco, California, United States, 94143