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Monoclonal Antibodies

Efgartigimod for Myasthenia Gravis (ADAPT NXT Trial)

Phase 3
Waitlist Available
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a Myasthenia Gravis - Activities of Daily Living (MG-ADL) total score ≥5 at screening and the day 1 visit, with more than 50% of the score due to nonocular symptoms
Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti-acetylcholine receptor antibodies (AChR-Abs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 136 weeks
Awards & highlights

ADAPT NXT Trial Summary

This trial is investigating if a continuous regimen of efgartigimod is more effective than a cyclic regimen in participants with Generalized Myasthenia Gravis.

Who is the study for?
Adults diagnosed with Generalized Myasthenia Gravis (gMG) who have muscle weakness and are positive for anti-acetylcholine receptor antibodies. Participants must be able to consent, follow study procedures, and use contraception if applicable. Excluded are those with serious diseases, recent major surgery, pregnancy or lactation, certain prior treatments including efgartigimod itself, active infections including COVID-19, other autoimmune diseases that could interfere with the study or pose a risk.Check my eligibility
What is being tested?
The trial is testing Efgartigimod IV's effectiveness in two dosing regimens: continuous versus cyclic. It aims to determine which regimen offers better efficacy while assessing safety over a period of up to 138 weeks. The first part compares regimens over 21 weeks; the second extends treatment up to an additional 105 weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to Efgartigimod IV administration throughout the trial duration. Side effects may include typical infusion-related responses such as allergic reactions or site irritation.

ADAPT NXT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My daily activities are significantly affected by my Myasthenia Gravis symptoms.
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I have been diagnosed with gMG and tested positive for AChR antibodies.
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I am on a stable dose of my gMG medication for at least 1 month.
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I am 18 years old or older.

ADAPT NXT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~136 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 136 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean of the average Myasthenia Gravis - Activities of Daily Living (MG-ADL) total score change from baseline during the visit of week (W)1 through W21 by regimen arm. A higher total score indicates more impairment.
Secondary outcome measures
Change from baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) total score over time. A higher total score indicates more impairment.
Characterization of MG-ADL total score change from baseline during the following 5 intervals using mean and standard deviation: Week 1 through Week 7, Week 8 through Week 14, Week 15 through Week 21, Week 8 through Week 21 and Week 1 through Week 21.
Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESIs)
+7 more

ADAPT NXT Trial Design

2Treatment groups
Experimental Treatment
Group I: efgartigimod IV - IIExperimental Treatment1 Intervention
Patients receiving efgartigimod IV treatment (Cyclic regimen: efgartigimod 10 mg/kg q7d for a total of 4 infusions per TP for 2 TPs with a fixed 4-week IP between each TP)
Group II: efgartigimod IV - IExperimental Treatment1 Intervention
Patients receiving efgartigimod IV treatment (Continuous regimen: efgartigimod 10 mg/kg q2w)

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
60 Previous Clinical Trials
9,201 Total Patients Enrolled
12 Trials studying Myasthenia Gravis
3,728 Patients Enrolled for Myasthenia Gravis

Media Library

Efgartigimod (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04980495 — Phase 3
Myasthenia Gravis Research Study Groups: efgartigimod IV - I, efgartigimod IV - II
Myasthenia Gravis Clinical Trial 2023: Efgartigimod Highlights & Side Effects. Trial Name: NCT04980495 — Phase 3
Efgartigimod (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04980495 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Efgartigimod for use as a 20 mg/mL infusion?

"Efgartigimod concentrate for solution for infusion 20 mg/mL is a Phase 3 trial drug, meaning that there is both some efficacy data and multiple rounds of safety data. Our team gives it a score of 3 on our safety scale."

Answered by AI

Who else is applying?

What site did they apply to?
Investigator Site 17 - US0010012
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have been on pyramisrigmine and low dose steroids (on and off) for 10 years. My MG is generally controlled but flairs making life difficult. In the last 6 months I have noticed an increase in muscle weakness in my arms and legs. I will be walking and almost stumble. I don’t want this to get worse and I want a better treatment plan.
PatientReceived 1 prior treatment
~21 spots leftby Mar 2025