Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

Last updated: March 7, 2025
Sponsor: Clinique Neuro-Outaouais
Overall Status: Active - Recruiting

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Treatment

efgartigimod administration

Clinical Study ID

NCT06765161
ESR-CA-NEU-96
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. No modification or addition of NSISTs in the past six months 5. No modificationor addition in corticosteroid therapy for the past three months 6. MyastheniaGravis diagnosis was supported by abnormal neurotransmission test or history ofimprovement with AChE inhibitors.

  3. Receiving chronic regular IVIG treatments for myasthenia gravis for the pastyear or more.

Exclusion

Exclusion Criteria:

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

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

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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: efgartigimod administration
Phase: 3
Study Start date:
February 06, 2025
Estimated Completion Date:
January 06, 2027

Study 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.

Connect with a study center

  • Clinique Neuro-Outaouais

    Gatineau, Quebec J8Y1W2
    Canada

    Active - Recruiting

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