Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06765161

Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

Led by Clinique Neuro-Outaouais · Updated on 2025-07-29

30

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

Sponsors

C

Clinique Neuro-Outaouais

Lead Sponsor

A

argenx

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Age between 18 and 80 years
  • Acetylcholine receptor antibody positive myasthenia gravis patients with stable disease for at least four months
  • No change in IVIG dosage or frequency during stable disease
  • No changes or additions to non-steroidal immunosuppressive therapies in the past six months
  • No changes or additions to corticosteroid therapy in the past three months
  • Myasthenia gravis diagnosis supported by abnormal neurotransmission test or improvement with acetylcholinesterase inhibitors
  • Receiving regular chronic IVIG treatments for myasthenia gravis for one year or more
Not Eligible

You will not qualify if you...

  • Previous rituxan, eculizumab treatment, or plasma exchange within the past six months
  • Thymectomy within the past three months
  • Active hepatitis B, seropositive for hepatitis C or HIV, latent untreated or active tuberculosis, or other significant active infections
  • Serum IgG less than 6.0 gm/L at screening or history of chronic hypogammaglobulinemia
  • Pregnant or planning to become pregnant within six months
  • Severe renal impairment (eGFR less than 30 ml/min)
  • Investigator's judgment that participation is not appropriate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinique Neuro-Outaouais

Gatineau, Quebec, Canada, J8Y1W2

Actively Recruiting

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Research Team

F

François Jacques, Doctor

CONTACT

V

Victorine Sikati Foko, Nurse

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Efgartigimod in IVIG Dependent Myasthenia Gravis Patients | DecenTrialz