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A study to assess efficacy and safety of efgartigimod PH20 SC in adults with ocular myasthenia gravis
EU CTIS ID: 2024-514133-38-00
What this study is testing
To determine the efficacy of efgartigimod PH20 SC compared to placebo PH20 SC (placebo) in participants with oMG in part A
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Is at least 18 years of age and the local legal age of consent for clinical studies
- 2. 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
- 3. Is MGFA Class I (any ocular muscle weakness)
- 4. 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 likely can't join if
- 1. Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia
- 2. 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- China
- Japan
- Georgia
- United Kingdom
- United Arab Emirates
- United States
- Canada
- Korea, Republic of
- Saudi Arabia
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; China; Japan; Georgia; United Kingdom; United Arab Emirates and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.