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ACTIVE NOT RECRUITING Phase 3

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

NCT06558279 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 141 participants
Start Date 2024-09-18
Est. Completion 2027-12
Phase Phase 3

Sponsor

argenx

96 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06558279

The ClinicalTrials.gov registry entry for NCT06558279 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06558279 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06558279?

The interventions under investigation include: Efgartigimod PH20 SC (COMBINATION_PRODUCT), Placebo PH20 SC (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06558279?

This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial