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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 belowSelect...
My daily activities are significantly affected by my Myasthenia Gravis symptoms.
Select...
I have been diagnosed with gMG and tested positive for AChR antibodies.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 136 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~136 weeks
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 moreADAPT 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to efgartigimod or any of its ingredients before.You have another autoimmune disease that might make it hard to understand the symptoms of the condition being studied or put you at risk.I have not used certain medications within specific timeframes.You have a current viral infection based on a blood test.My daily activities are significantly affected by my Myasthenia Gravis symptoms.I have been diagnosed with gMG and tested positive for AChR antibodies.You have been diagnosed with Myasthenia Gravis and your condition falls into MGFA class II, III, or IV.Your total IgG level is less than 6 g/L during screening.I had cancer before but have been cancer-free for over 3 years, or I have specific cancers that are currently treated.I am on a stable dose of my gMG medication for at least 1 month.I am 18 years old or older.I do not have any serious ongoing infections.I had my thymus gland removed within the last 3 months.I have not received any live vaccines in the last 4 weeks.You have tested positive for the virus that causes COVID-19 during the screening process.
Research Study Groups:
This trial has the following groups:- Group 1: efgartigimod IV - I
- Group 2: efgartigimod IV - II
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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