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A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
NCT06298565 · View on ClinicalTrials.gov ↗
Study Summary
This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.
Conditions Studied
Interventions
- BIOLOGICAL efgartigimod
Study Locations (20)
Florida
- SFM Clinical Research, LLC — Boca Raton
- University of Florida College of Medicine Jacksonville — Jacksonville Beach
- Medsol Clinical Research Center Inc — Port Charlotte
- BayCare Health System, Inc. St Anthony's Hospital — St. Petersburg
Other
- Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III — Linz
- UZ Leuven (University Hospitals Leuven) — Leuven
- Klinikum Altenburger Land GmbH — Altenburg
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
Oregon
- Oregon Health and Science University — Portland
- University of Colorado Hospital — Portland
California
- UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center, — San Francisco
Illinois
- Prairie Education and Research Cooperative and HSHS Medical Group — O'Fallon
Iowa
- University of Iowa — Iowa City
Kansas
- University of Kansas Medical Center — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2034-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06298565
The ClinicalTrials.gov registry entry for NCT06298565 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 680 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 appearing as the primary indexed condition, and to 1 intervention — of which efgartigimod 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: NCT06298565 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Other, Massachusetts. 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 NCT06298565 about?
NCT06298565 is a clinical study titled "A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa". This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who...
What is the current status of trial NCT06298565?
This trial is currently recruiting. The enrollment target is 680 participants. The study started on 2024-11-04. Estimated completion is 2034-06.
What conditions does trial NCT06298565 study?
This clinical trial studies the following conditions: Myasthenia Gravis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06298565?
The interventions under investigation include: efgartigimod (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06298565?
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 NCT06298565 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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