Efgartigimod treatment for patients with myasthenia gravis dependent on IVIG
Official title: Efgartigimod in IVIG Dependent Myasthenia Gravis Patients
Run by Clinique Neuro-Outaouais · NCT06765161 · Data updated 2026-11-12
This study is testing if a new treatment called efgartigimod can safely replace IVIG for people with myasthenia gravis who have stable symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Clinique Neuro-Outaouais Academic / other |
| Drugs / interventions | eculizumab |
| Locations | 1 site (Gatineau, Quebec) |
| Status | Recruiting |
| Started | February 6, 2025 |
| Main results expected | January 6, 2027 |
| Study ends | January 6, 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT06765161 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with stable, acetylcholine receptor antibody positive myasthenia gravis who have been dependent on IVIG for treatment.
✕Probably not a fit
Patients who have received rituxan or eculizumab treatment, or plasma exchange within the past six months, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy of efgartigimod as a replacement for intravenous immunoglobulin (IVIG) in patients with stable, acetylcholine receptor antibody positive myasthenia gravis. The study is open-label and will last for 26 weeks, during which patients will receive efgartigimod infusions weekly for four weeks, followed by a break and repeated treatment cycles. The trial aims to assess not only the efficacy of efgartigimod compared to IVIG but also patient preferences and the safety of the treatment regimen. Weekly evaluations of myasthenia gravis symptoms and quality of life will be conducted throughout the study period.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and preferable alternative to IVIG for managing myasthenia gravis.
How similar studies have gone: Other studies have shown promising results with efgartigimod in similar conditions, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Clinique Neuro-Outaouais
Gatineau, Quebec, Canada Recruiting
Study contacts
- Principal investigator: François Jacques, Doctor — Clinique Neuro-Outaouais
- Study coordinator: François Jacques, Doctor
- Email: francois.jacques@neuro-outaouais.ca
- Phone: 819-777-2500
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Registry for people living with Myasthenia Gravis
This study is collecting information from people with Myasthenia Gravis to understand their experiences, symptoms, and treatments over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.