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Monoclonal Antibodies

Efgartigimod IV for Myasthenia Gravis (ADAPT Jr Trial)

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
Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation
Male or female participants between 2 to less than 18 years of age
Must not have
Clinical evidence of other significant serious diseases or recent major surgery
Documented lack of clinical response to plasma exchange (PLEX)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have been diagnosed with Generalized Myasthenia Gravis.
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I am between 2 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a major surgery or serious disease recently.
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I did not improve after receiving plasma exchange treatment.
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I am not pregnant, breastfeeding, or planning to become pregnant.
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My myasthenia gravis is classified as MGFA class I, IVb, or V.
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I have not received a live vaccine in the last 4 weeks.
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I do not have any serious ongoing infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 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
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 more
Secondary study objectives
Absolute values of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y)
Change from baseline of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EfgartigimodExperimental Treatment1 Intervention
Patients receiving efgartigimod intravenous (IV) treatment
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
72 Previous Clinical Trials
11,104 Total Patients Enrolled
15 Trials studying Myasthenia Gravis
4,785 Patients Enrolled for Myasthenia Gravis

Media Library

Efgartigimod IV (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04833894 — Phase 2 & 3
Myasthenia Gravis Research Study Groups: Efgartigimod
Myasthenia Gravis Clinical Trial 2023: Efgartigimod IV Highlights & Side Effects. Trial Name: NCT04833894 — Phase 2 & 3
Efgartigimod IV (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04833894 — Phase 2 & 3
~5 spots leftby Mar 2027
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