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Monoclonal Antibodies

Efgartigimod for Myasthenia Gravis (ADAPT SERON Trial)

Phase 3
Recruiting
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or puts the participant at undue risk
Received a thymectomy less than 3 months before screening or thymectomy is planned during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 29 days during part a
Awards & highlights
Pivotal Trial

Summary

This trial is testing a drug called efgartigimod given intravenously to see if it is effective and safe for people with Generalized Myasthenia Gravis. The study will

Who is the study for?
This trial is for adults with seronegative Generalized Myasthenia Gravis (gMG), who can consent and follow the study plan. They must use birth control if applicable, have a negative pregnancy test if female, and show signs of MG that improve with certain treatments or tests.
What is being tested?
The study compares Efgartigimod IV to a placebo in treating gMG. Participants are randomly chosen to receive either the drug or placebo. Those completing this part will later all receive Efgartigimod in an open-label extension.
What are the potential side effects?
Possible side effects of Efgartigimod include reactions at the injection site, headaches, fatigue, and potential changes in immune response which could increase infection risk or cause other immune-related issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have autoimmune diseases that could affect my gMG symptom assessment.
Select...
I had or will have surgery to remove my thymus gland within 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 29 days during part a
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 29 days during part a for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline
Secondary study objectives
Quantitative myasthenia gravis (QMG) total score change from baseline

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Efgartigimod IVExperimental Treatment1 Intervention
Patients receiving efgartigimod IV in both part A and part B
Group II: PlaceboPlacebo Group2 Interventions
Patients receiving placebo during part A and receiving efgartigimod IV during part B
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efgartigimod IV
2023
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
71 Previous Clinical Trials
10,970 Total Patients Enrolled
15 Trials studying Myasthenia Gravis
4,687 Patients Enrolled for Myasthenia Gravis
~59 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
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