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 ("Protocol")
A Study On:
Brain - Neurologic/ Psychologic
Myasthenia Gravis
Neuromuscular Diseases
Study Description
Eligibility
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
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
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.
Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
In the instance of parental permission, “You” refers to “Your child.”
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