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Evaluating a new treatment for ocular myasthenia gravis

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

Phase 3 Interventional argenx · NCT06558279

This study is testing a new treatment for adults with ocular myasthenia gravis to see if it helps improve their symptoms and is safe to use.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment124 (estimated)
Ages18 Years and up
SexAll
Sponsorargenx Industry-sponsored
Locations49 sites (Boca Raton, Florida and 48 other locations)
Trial IDNCT06558279 on ClinicalTrials.gov

What this trial studies

This study assesses the efficacy and safety of efgartigimod PH20 SC in adults diagnosed with ocular myasthenia gravis. It consists of two parts: the first part lasts approximately 7 weeks, where participants are randomly assigned to receive either the treatment or a placebo. The second part extends up to 2 years, during which all participants will receive the treatment. The study aims to determine how well the treatment works and its safety profile over an extended period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of ocular myasthenia gravis and specific clinical scores indicating the severity of their condition.

Not a fit: Patients with other diseases causing similar symptoms or those with known autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from ocular myasthenia gravis.

How similar studies have performed: Other studies have shown promise with similar treatments for myasthenia gravis, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Boca Raton, Florida and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myasthenia Gravis, OcularMyasthenia GravisOcular myasthenia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.