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NCT06558279 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis
A Phase 3 study of Myasthenia Gravis, Ocular, sponsored by argenx.
- Active
- Registry status
- Phase 3
- Development phase
- 141
- Enrollment target
- 20
- Study locations
NCT06558279: Active Phase 3 study of Myasthenia Gravis, Ocular, sponsored by argenx.
NCT06558279 is a Phase 3 study of Myasthenia Gravis, Ocular that is active but no longer recruiting, run by argenx. The registered enrollment target is 141 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06558279, a Phase 3 study of Myasthenia Gravis, Ocular, is active but no longer recruiting, sponsored by argenx.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 141 participants
- Enrollment target
- 20
- Study locations
Study 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 (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.
Primary Outcome
The Myasthenia Gravis Impairment Index (MGII) is a scoring tool measuring disease severity. It consists of 22 patient-reported outcomes (PRO) and 6 physical examinations (PE). The Ocular PRO score varies between 0 and 18. The higher the score, the more severe the disease.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Efgartigimod PH20 SC
- OTHER Placebo PH20 SC
Study Locations (20)
Florida
- Neurology Offices of South Florida - Boca Raton
- SFM Clinical Research, LLC - Boca Raton
- Neurology Associates PA - Maitland
- University of South Florida - Tampa
California
- Loma Linda University Health - Loma Linda
- USC Roski Eye Institute - Los Angeles - Los Angeles
- University of California San Francisco - San Francisco
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke Neurological Disorders Clinic - Durham
Ohio
- Cleveland Clinic - Cleveland
- Martha Morehouse Medical plaza - Columbus
Texas
- National Neuromuscular Research Institute - Austin
- Houston Methodist Neurological Institute - Houston
Arizona
- HonorHealth Neurology - Bob Bové Neuroscience Institute - Scottsdale
Illinois
- Northwestern Memorial Hospital - Chicago
Maryland
- University of California Irvine - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What the registry record for NCT06558279 still lists
NCT06558279 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Myasthenia Gravis, Ocular appearing as the primary indexed condition, and to 2 interventions - of which Efgartigimod PH20 SC is the first listed.
NCT06558279 names 20 study sites across 12 states, led by Florida, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06558279 about?
NCT06558279 is a clinical study titled "A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis". 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 (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receiv...
What is the current status of trial NCT06558279?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2024-09-18. Estimated completion is 2027-12.
What conditions does trial NCT06558279 study?
This clinical trial studies the following conditions: Myasthenia Gravis, Ocular.
What interventions are being tested in trial NCT06558279?
The interventions under investigation include: Efgartigimod PH20 SC (COMBINATION_PRODUCT), Placebo PH20 SC (OTHER).
Who is sponsoring clinical trial NCT06558279?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06558279 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06558279's enrollment target sits among peer trials
141 1564th of 2000 higher than 436 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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