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Monoclonal Antibodies

Efgartigimod for Myasthenia Gravis

Phase 3
Recruiting
Led By Vera Bril, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable or worsening MG as defined by specific criteria
MGFA Clinical Classification Class II, III, or IV at screening and baseline
Must not have
Patients with renal/hepatic function impairment at screening
Patients with clinically significant uncontrolled infections at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion for 42 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will test how well efgartigimod works and how safe it is for patients with a specific type of myasthenia gravis. It will involve 30 participants at a

Who is the study for?
This trial is for individuals with seronegative generalized myasthenia gravis, a condition causing muscle weakness. Participants will be treated at the University Health Network Toronto General Hospital and must commit to a study duration of 43 weeks.
What is being tested?
The trial is testing efgartigimod's effectiveness, safety, and tolerability in treating muscle weakness due to myasthenia gravis. It's an open-label study which means everyone knows they're getting efgartigimod; no placebos are used.
What are the potential side effects?
Possible side effects of efgartigimod may include reactions at the injection site, headaches, fatigue or flu-like symptoms. Since it affects the immune system, there might also be an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My myasthenia gravis symptoms are not improving.
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My myasthenia gravis is moderate to severe.
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My myasthenia gravis is moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney or liver is not working properly.
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I do not have any uncontrolled infections.
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I am a male not using contraception or planning to donate sperm.
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I have tested positive for HBV, HCV, or HIV.
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I have received rituximab or eculizumab in the last 6 months.
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I have had a major surgery or significant illness recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion for 42 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion for 42 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total Myasthenia Gravis Impairment Index (MGII) score
Secondary study objectives
MG-ADL (Myasthenia Gravis-Activities of Daily Living)
MG-QOL (Myasthenia Gravis Quality of Life)
Myasthenia Gravis Foundation of America (MGFA)
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: efgartigimodExperimental Treatment1 Intervention
active treatment with efgartigimod.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
efgartigimod
2019
Completed Phase 3
~140

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,308 Total Patients Enrolled
3 Trials studying Myasthenia Gravis
167 Patients Enrolled for Myasthenia Gravis
Vera Bril, MDPrincipal InvestigatorToronto General Hospital
2 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
50 Patients Enrolled for Myasthenia Gravis
~7 spots leftby May 2025
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