Efgartigimod for Myasthenia Gravis
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those who have used certain treatments like IVIG, plasma exchange, or efgartigimod recently. It also excludes those using specific medications like ravulizumab or eculizumab.
What data supports the effectiveness of the drug Efgartigimod for Myasthenia Gravis?
Efgartigimod has been shown to significantly reduce disease symptoms and improve muscle strength and quality of life in patients with generalized myasthenia gravis, as demonstrated in the phase 3 ADAPT trial. The benefits were consistent and well-tolerated, with most side effects being mild to moderate.12345
Is efgartigimod safe for humans?
How is the drug efgartigimod different from other treatments for myasthenia gravis?
What is the purpose of this trial?
This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive but has not been studied in the treatment of worsening weakness requiring hospital admission (known as "exacerbation"). This investigation aims to see if using efgartigimod in this way improves symptoms and recovery from exacerbation, and how it affects certain MG markers in the blood. The main questions it aims to answer are:* Is efgartigimod effective as a hospital-administered acute therapy for participants with worsening MG (MG exacerbation) who require hospitalization?* Will efgartigimod lead to clinical improvement with a similar reduction in validated research scales, such as the Quantitative MG (QMG) scale, as standard of care therapies?Participants will receive 4 doses of efgartigimod over the course of 4 weeks with an additional follow-up visit at the clinic.
Research Team
Thomas Ragole, MD
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
This trial is for hospitalized adults with myasthenia gravis (MG) experiencing a worsening of symptoms, known as an exacerbation. Participants must have MG that's confirmed by specific antibodies. Details on who can't join are not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 doses of efgartigimod via intravenous (IV) infusion on days 1, 4, 11, and 18
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at day 32
Treatment Details
Interventions
- Efgartigimod
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
argenx
Industry Sponsor
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University