Recruiting
Phase 3

Efgartigimod

Sponsor:

Clinique Neuro-Outaouais

Code:

NCT06765161

Conditions

Myasthaenia Gravis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

efgartigimod administration

Study Details

Brief 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.

Conditions

Myasthaenia Gravis

Study ID

NCT06765161

Start date

Feb 6, 2025

Status verified date

Jul, 2025

Completion date

Jan 6, 2027

Anticipated

Primary completion date

Jan 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: treatment

Efgartigimod infusion

Interventions

efgartigimod administration

efgartigimod infusion

Primary outcome measure

  • MG-ADL [ Time Frame: a sustained decrease persistent for at least 4 consecutive weeks over the 26 week period ]

Central Contacts and Locations

Central contacts

Victorine Sikati Foko, Nurse

8197772500

Locations

Clinique Neuro-Outaouais

Recruiting

Gatineau, Quebec, Canada, J8Y1W2

Contacts

Principal Investigator:

François Jacques, Neurologist

More Information

Sponsor

Clinique Neuro-Outaouais

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Keywords

  • Myasthenia gravis
  • Vyvgart
  • IVIG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clinique Neuro-Outaouais on 2025-07-29.