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

Launched by ARGENX · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called efgartigimod PH20 SC for adults with ocular myasthenia gravis, a condition that affects the eye muscles and can cause drooping eyelids and double vision. The trial is divided into two parts: the first part lasts about 7 weeks, where half of the participants will receive the medication and the other half will receive a placebo (a treatment with no active ingredients). The second part of the study lasts up to 2 years, during which all participants will receive the actual medication.

To participate, you must be at least 18 years old and have been diagnosed with ocular myasthenia gravis, confirmed by specific tests. You should also have some weakness in the eye muscles. However, individuals with other conditions that cause similar eye issues or other autoimmune diseases may not be eligible. If you join the trial, you can expect regular check-ups and assessments to see how well the treatment is working and if it’s safe for you. This study is currently recruiting participants, and it aims to provide valuable information about the effectiveness and safety of this new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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