Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

July 25, 2025 updated by: Dr. Francois Jacques, Clinique Neuro-Outaouais
This study is an open label, single center, prospective, 26 weeks study with descriptive analysis where IVIG is replaced by efgartigimod therapy. MG-ADL and MGQOL evaluations will occur weekly throughout the study to week 26.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

To determine if efgartigimod is equivalent or non-inferior in efficacy to IVIG in the treatment of stable, acetylcholine receptor antibody positive, IVIG dependent myasthenia gravis patients.

To determine patient treatment preference between IVIG and efgartigimod in stable, IVIG dependent acetylcholine receptor antibody positive myasthenia gravis patients.

To determine the safety and tolerability of efgartigimod administered in a fixed regular dosing regimen over 6 months in stable IVIG dependent acetylcholine receptor antibody positive myasthenia gravis patients.

IVIG will be discontinued one week prior to the baseline visit (week 0) while other concurrent medications (non-steroidal immunosuppressive therapies (NSISTs), acetylcholinesterase (AChE) inhibitors or corticosteroids) for myasthenia will be kept unchanged for the duration of the study. The dose and frequency of efgartigimod treatment will be 10mg/kg (max of 1200mg) administered as a one-hour intravenous infusion every week x 4 infusions followed by a four-week break and repeated for a total four treatment cycles till week 24 and then followed by a two-week observation with an end of study visit at week 26.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Victorine Sikati Foko, Nurse
  • Phone Number: 211 8197772500

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Gatineau, Quebec, Canada, J8Y1W2
        • Recruiting
        • Clinique Neuro-Outaouais
        • Contact:
        • Principal Investigator:
          • Francois Jacques, Neurologist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Signed informed consent. 2. Age 18-80 years 3. Acetylcholine receptor antibody positive, myasthenia gravis patients, with stable disease for the past four or more months. Stable disease is defined as no change in dosage or interval in IVIG treatments and without any significant change in clinical status.

    4. No modification or addition of NSISTs in the past six months 5. No modification or addition in corticosteroid therapy for the past three months 6. Myasthenia Gravis diagnosis was supported by abnormal neurotransmission test or history of improvement with AChE inhibitors.

    7. Receiving chronic regular IVIG treatments for myasthenia gravis for the past year or more.

Exclusion Criteria:

  • 1. Patients with previous rituxan or eculizumab treatment or plasma exchange within the past six months 2. Patients with previous thymectomy within the past 3months 3. Patients that have active Hepatitis B, are seropositive for Hepatitis C or HIV or have latent, untreated or active TB or any other significant active infection 4. Patients that have at screening a serum IgG less than 6.0gm/L or a history of chronic hypogammaglobulinemia from any cause.

    5. Patients that are pregnant or considering becoming pregnant in the next 6 months.

    6. Patients with severe renal impairment (eGFR less than 30ml/min) 7. Patients who in the opinion of the investigator should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
Efgartigimod infusion
Drug: efgartigimod administration
efgartigimod infusion
Other Names:
  • Vyvgart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MG-ADL
Time Frame: a sustained decrease persistent for at least 4 consecutive weeks over the 26 week period
The percentage of patients who do not experience, at any time during the study, a 2 or more-point deterioration from their averaged baseline MG-ADL score that is sustained for a period of 4 or more consecutive weeks. (stable or improved patients)
a sustained decrease persistent for at least 4 consecutive weeks over the 26 week period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QMG
Time Frame: those who experience a sustained decrease for 4 consecutive weeks during the 26 week period
The percentage of patients who do not experience, at any time during the study, a 3 or more-point deterioration from their baseline QMG score that is sustained for a period of 4 or more consecutive weeks. (stable or improved patients)
those who experience a sustained decrease for 4 consecutive weeks during the 26 week period
MGQOL
Time Frame: during the whole study period of 26 weeks
The change in group, mean MGQOL score from the averaged baseline to the week 26 end of study visit.
during the whole study period of 26 weeks
incidence of patients who are still receiving efgartigimod by the end of the 26 weeks
Time Frame: for the duration of the 26 week study
incidence of patients who are still receiving efgartigimod by the end of the 26 weeks
for the duration of the 26 week study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Neuro-Outaouais

Collaborators

argenx

Investigators

  • Principal Investigator: François Jacques, Doctor, Clinique Neuro-Outaouais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Estimated)

January 6, 2027

Study Completion (Estimated)

January 6, 2027

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-CA-NEU-96

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myasthaenia Gravis

Clinical Trials on efgartigimod administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe