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Monoclonal Antibodies
Efgartigimod IV for Myasthenia Gravis
Phase 2 & 3
Recruiting
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Agreement by male participants to not donate sperm during the trial
Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 weeks
Awards & highlights
Study Summary
This trial is investigating the effects of a drug called efgartigimod in children and adolescents aged 2-18 with a condition called gMG. The trial will last up to 28 weeks for each participant, and will involve two parts: a dose-confirmatory part (8 weeks) and a treatment response-confirmatory part (18 weeks).
Who is the study for?
This trial is for children and adolescents aged 2 to less than 18 with Generalized Myasthenia Gravis (gMG). They must have tried other treatments without success, not be pregnant, use contraception consistently, and not have had recent major surgery or certain infections. Those with mild gMG or severe muscle weakness from other causes can't join.Check my eligibility
What is being tested?
The study tests Efgartigimod IV in young patients with gMG over approximately 28 weeks. It has two parts: an initial dose-confirmatory phase lasting 8 weeks and a subsequent treatment response-confirmatory phase of 18 weeks to assess the drug's effects on their condition.See study design
What are the potential side effects?
Possible side effects include allergic reactions to Efgartigimod or its ingredients. Since it affects the immune system, there may also be risks of infection or inflammation as well as potential impacts on growth and development due to the patient age group.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to donate sperm during the trial.
Select...
I have been diagnosed with Generalized Myasthenia Gravis.
Select...
I am between 2 and 17 years old.
Select...
My condition did not improve with immunosuppressants, steroids, or AChE inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-acetylcholine receptors antibodies (AChR-Ab) as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis
Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Clearance (CL)
Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Volume of Distribution (Vd)
+1 moreSecondary outcome measures
Absolute values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Absolute values of levels of total Immunoglobulin G (IgG) from blood samples
Absolute values of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment.
+16 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: EfgartigimodExperimental Treatment1 Intervention
Patients receiving efgartigimod intravenous (IV) treatment
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Who is running the clinical trial?
argenxLead Sponsor
60 Previous Clinical Trials
9,258 Total Patients Enrolled
12 Trials studying Myasthenia Gravis
3,785 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to donate sperm during the trial.I have been diagnosed with Generalized Myasthenia Gravis.Female participants must have a negative pregnancy test.I have had a major surgery or serious disease recently.I have had, or will have, a thymectomy within 3 months of joining the trial.You are allergic to efgartigimod or any of its ingredients.You have had problems with alcohol, drugs, or medication within the past year.You have a current active viral infection shown in a blood test.I have used specific medications or treatments recently.Your immunoglobulin (IgG) levels are too low.I am between 2 and 17 years old.You have been diagnosed with Myasthenia Gravis and fall into MGFA classes II, III, or IVa.My condition did not improve with immunosuppressants, steroids, or AChE inhibitors.I did not improve after receiving plasma exchange treatment.You have a positive test for anti-AChR antibodies.My muscle weakness is getting worse because of an infection or medication.I am not pregnant, breastfeeding, or planning to become pregnant.My myasthenia gravis is classified as MGFA class I, IVb, or V.I have an autoimmune disease that could affect myasthenia gravis evaluation.I had cancer before but was treated successfully.I have not received a live vaccine in the last 4 weeks.I do not have any serious ongoing infections.
Research Study Groups:
This trial has the following groups:- Group 1: Efgartigimod
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Does this study only include seniors, or can people of all ages participate?
"The target age range for participants in this trial are children that are at least 2 years old, but not yet adults at 18 years old."
Answered by AI
Are there still places available in this research program for new participants?
"That is correct. According to the listing on clinicaltrials.gov, this trial is still looking for participants. The study was first posted on October 26th, 2021 and was most recently updated on November 2nd, 2020. At the moment, the study is only admitting 12 patients from 2 different sites."
Answered by AI
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