Recruiting PHASE3 Myasthaenia Gravis

New treatment option for Myasthaenia Gravis

Official title Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

ClinicalTrials.gov ID: NCT06765161

What this study is testing

What is efgartigimod administration?

efgartigimod administration is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for myasthaenia gravis.

Also referred to as Vyvgart.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Time commitment: about 6 months

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • 1\. Signed informed consent. 2. Age 18-80 years 3. Acetylcholine receptor antibody positive, myasthenia gravis patients, with stable disease for the...
  • 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...
  • 7\. Receiving chronic regular IVIG treatments for myasthenia gravis for the past year or more.

You likely can't join if

  • 1\. Patients with previous rituxan or eculizumab treatment or plasma exchange within the past six months 2. Patients with previous thymectomy within...
  • 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...

The study team makes the final eligibility decision.

Where it's taking place

  • Gatineau, Quebec, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Gatineau, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.