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Monoclonal Antibodies

Efgartigimod for Myasthenia Gravis (ADAPT oculus 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
* Is MGFA Class I (any ocular muscle weakness)
* Is at least 18 years of age and the local legal age of consent for clinical studies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 111 weeks
Awards & highlights
Pivotal Trial

Summary

This trial aims to test the effectiveness and safety of efgartigimod PH20 SC given via a pre-filled syringe in adult patients with ocular myasthenia gravis. The

Who is the study for?
This trial is for adults with ocular myasthenia gravis, a condition causing muscle weakness. Participants must have a confirmed diagnosis supported by specific tests or positive response to treatments, be at least 18 years old, and show certain levels of eye muscle weakness.
What is being tested?
The study is testing Efgartigimod PH20 SC's effectiveness and safety in treating ocular myasthenia gravis. Initially, half the participants will receive the actual drug and half a placebo. Afterward, all participants will receive Efgartigimod for up to two years.
What are the potential side effects?
While not specified here, potential side effects may include reactions at the injection site, allergic responses to ingredients in the medication, general fatigue or discomfort as commonly seen with immune-modulating therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have weakness in my eye muscles.
Select...
I am at least 18 years old and legally eligible to consent for clinical studies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 111 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 111 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
MGII (PRO) ocular score change from baseline to day 29 in part A
Secondary study objectives
MG-ADL ocular domain score change from baseline to day 29 in part A
MG-ADL total score change from baseline to day 29 in part A
MG-QoL15r total score changes from baseline in part A+B
+5 more

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
Group I: Placebo PH20 SC in Part A + Efgartigimod PH20 SC in Part BExperimental Treatment2 Interventions
Participants receiving placebo PH20 SC in Part A and Efgartigimod PH20 SC in Part B
Group II: Efgartigimod PH20 SC in part A+BExperimental Treatment1 Intervention
Participants receiving efgartigimod PH20 SC during part A and part B
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efgartigimod PH20 SC
2020
Completed Phase 3
~210

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
71 Previous Clinical Trials
10,956 Total Patients Enrolled
15 Trials studying Myasthenia Gravis
4,673 Patients Enrolled for Myasthenia Gravis
~83 spots leftby Dec 2025
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