A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

NCT06298565 · tracked via the Priya Life Science USA tracker

Sponsor

argenx

Phase

Observational

Started

2024-11-04

Last updated

2026-02-17

Condition(s) studied

Myasthenia Gravis

Investigational drug(s) / intervention(s)

efgartigimod →

efgartigimod: efgartigimod

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment * Have provided appropriate written informed consent Exclusion Criteria: * None

Primary outcome measure(s)

The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod — up to 10 years

Trial sites (35)

Facility	City	Region	Status
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,	San Francisco	California	Recruiting
SFM Clinical Research, LLC	Boca Raton	Florida	Recruiting
University of Florida College of Medicine Jacksonville	Jacksonville Beach	Florida	Recruiting
Medsol Clinical Research Center Inc	Port Charlotte	Florida	Recruiting
BayCare Health System, Inc. St Anthony's Hospital	St. Petersburg	Florida	Recruiting
Prairie Education and Research Cooperative and HSHS Medical Group	O'Fallon	Illinois	Recruiting
University of Iowa	Iowa City	Iowa	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
Norton Neuroscience Institute	Louisville	Kentucky	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
Henry Ford Health System	Detroit	Michigan	Recruiting
Oregon Health and Science University	Portland	Oregon	Recruiting
University of Colorado Hospital	Portland	Oregon	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
National Neuromuscular Research Institute	Austin	Texas	Recruiting
BCN Research, LLC - Gamma Therapeutic Center	Greenfield	Wisconsin	Recruiting
Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III	Linz	Austria	Recruiting
UZ Leuven (University Hospitals Leuven)	Leuven	Belgium	Recruiting
Klinikum Altenburger Land GmbH	Altenburg	Germany	Recruiting
St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum	Bochum	Germany	Recruiting
Klinikum Christophsbad	Göppingen	Germany	Recruiting
Georg-August-Universität Göttingen	Göttingen	Germany	Recruiting
Klinikum Oberberg	Gummersbach	Germany	Recruiting
Universitätsklinikum Jena	Jena	Germany	Recruiting
Universitätsklinikum Würzburg	Würzburg	Germany	Recruiting
Piazza OMS - Organizzazione Mondiale della Sanità	Bergamo	Italy	Recruiting
Ospedale Bellaria - Clinica Neurologica	Bologna	Italy	Recruiting
Azienda Ospedaliera di Rilievo Nazionale Cardarelli	Naples	Italy	Recruiting
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy	Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Italy	Recruiting
Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia	Barcelona	Spain	Recruiting
Hospital Universitari de Bellvitge	Barcelona	Spain	Recruiting
Hospital Clinico Universitario San Carlos	Madrid	Spain	Recruiting
Hospital Universitario Virgen Macarena	Seville	Spain	Recruiting

More argenx trials in the USA

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia Active, not recruiting

A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome Active, not recruiting

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Recruiting

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) Active, not recruiting

A Natural History Study in Participants With Congenital Myasthenic Syndromes (CMS) Due to Mutations in DOK7, MUSK, AGRN, or LRP4 Recruiting

Other trials for the same condition

KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis Recruiting

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis Recruiting

Vitaccess Real MG Registry Recruiting

SP Thoracic IDE Study Active, not recruiting

Myasthenia Gravis Inebilizumab Trial Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06298565 on ClinicalTrials.gov ↗ ← All trials in the USA