NCT06765161RecruitingPhase 3
Efgartigimod in IVIG Dependent Myasthenia Gravis Patients
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Jan 2025
- Start date
- 6 Feb 2025
- Primary completion date
- 6 Jan 2027
- Lead sponsor
- Clinique Neuro-Outaouais
- Diseases
- Myasthenia gravis
- NCT number
- NCT06765161
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 30
- From 6 Feb 2025 to the primary completion date, 6 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Neuro-Outaouais Coordinator of this site? Confirm its status | Gatineau | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.