Myasthenia GravisNCT06298565
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
An observational study of Myasthenia Gravis, run by argenx at 35 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- efgartigimod
- How many people
- 680 participants
- Where
- 35 sitesin 6 countries
- Study dates
- 4 Nov 2024to Jun 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with gMG
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
35 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 6 countries
United States17 sites, 17 recruiting
- Recruiting
National Neuromuscular Research Institute
Austin, Texas, 78759
Yessar Hussain, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
SFM Clinical Research, LLC
Boca Raton, Florida, 33487
Marc Feinberg, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Amanda Guidon, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Pushpa Narayanaswami, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Katherine Ruzhansky, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Kavita Grover, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
BCN Research, LLC - Gamma Therapeutic Center
Greenfield, Wisconsin, 53228
Bhupendra Khatri, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Christopher Nance, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of Florida College of Medicine Jacksonville
Jacksonville Beach, Florida, 32209
Michael Pulley, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Mamatha Pasnoor, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Norton Neuroscience Institute
Louisville, Kentucky, 40241
Richard Lewis, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Prairie Education and Research Cooperative and HSHS Medical Group
O'Fallon, Illinois, 62701
Raghav Govindarajan, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Medsol Clinical Research Center Inc
Port Charlotte, Florida, 33952
George Li, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Nizar Chahin, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of Colorado Hospital
Portland, Oregon, 97239
Thomas Ragole, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,
San Francisco, California, 94143
Min Kang, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
BayCare Health System, Inc. St Anthony's Hospital
St. Petersburg, Florida, 33705
Michael Rosario-Prieto, MD, 857-350-4834, clinicaltrials@argenx.com
Germany7 sites, 7 recruiting
- Recruiting
Klinikum Altenburger Land GmbH
Altenburg, 04600
Jörg Berrouschot, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum
Bochum, 44791
Christiane Schneider-Gold, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Klinikum Christophsbad
Göppingen, 7303
Katharina Althaus, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Georg-August-Universität Göttingen
Göttingen, 37073
Jana Zschüntzsch, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Klinikum Oberberg
Gummersbach, 51643
Franz Blaes, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Jena
Jena, 07747
Annekathrin Rödiger, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
Axel Haarmann, MD, 857-350-4834, clinicaltrials@argenx.com
Italy5 sites, 5 recruiting
- Recruiting
Piazza OMS - Organizzazione Mondiale della Sanità
Bergamo, 24127
Manlio Sgarzi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Ospedale Bellaria - Clinica Neurologica
Bologna, 40139
Maria Pia Giannoccaro, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Azienda Ospedaliera di Rilievo Nazionale Cardarelli
Naples, 80131
Francesco Habetswallner, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Michelangelo Maestri Tassoni, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Raffaele Iorio, MD, 857-350-4834, clinicaltrials@argenx.com
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia
Barcelona, 08035
Raul Juntas Morales, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Hospital Universitari de Bellvitge
Barcelona, 08907
Carlos Casasnovas, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Hospital Clinico Universitario San Carlos
Madrid, 28040
Lucia Galán Dávila, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Eva Maria Martinez Fernández, MD, 857-350-4834, clinicaltrials@argenx.com
Austria1 site, 1 recruiting
- Recruiting
Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III
Linz, 4021
Lukas Kellermair, MD, 857-350-4834, clinicaltrials@argenx.com
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven (University Hospitals Leuven)
Leuven, 3000
Kristl Claeys, MD, 857-350-4834, clinicaltrials@argenx.com
About this study
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
- Myasthenia Gravis
- Being tested
- efgartigimod
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efgartigimodBiological
efgartigimod
| Study group | Role | What they receive |
|---|---|---|
| efgartigimod cohort | patients treated with efgartigimod Receives: Biological: efgartigimod | |
| non-efgartigimod cohort | patient treated with other MG medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start4 Nov 2024
- Primary completionJun 2034 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298565
- Sponsor's protocol ID
- ARGX-113-PASS-2208
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
- ClinicalTrials.gov ID
- NCT06298565
- Acronym / sponsor ID
- ARGX-113-PASS-2208
- Conditions
- Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Jun 2034 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| efgartigimod cohort | – | Biological: efgartigimodpatients treated with efgartigimod |
| non-efgartigimod cohort | – | –patient treated with other MG medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with gMG
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efgartigimodefgartigimod | Biological | efgartigimod cohort |
Primary outcome
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
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Myasthenia Gravis
RecruitingPhase 3
A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)
Myasthenia Gravis, Generalized
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis
Myasthenia Gravis, Generalized
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
Myasthenia Gravis
Active, not recruitingPhase 4
Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis
Myasthenia Gravis
Active, not recruitingPhase 2/3
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by argenx at 35 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Germany, Italy, Spain, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, Clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.