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Monoclonal Antibodies

Efgartigimod for Myasthenia Gravis (ADAPT Jr SC 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
Participant is aged 2 to <18 years at the time of informed consent/assent
Participant has been diagnosed with generalised Myasthenia Gravis supported by a physical examination and confirmed seropositivity for anti-acetylcholine receptor antibodies
Must not have
Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of generalised Myasthenia Gravis or puts the participant at undue risk
Female adolescent of child-bearing potential who is pregnant and/or lactating or intends to become pregnant during their participation in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the effects of a drug called efgartigimod PH20 SC in children aged 2 to under 18 years with generalized myasthenia gravis. The

Who is the study for?
This trial is for children aged 2 to less than 18 with generalized Myasthenia Gravis (gMG), confirmed by tests. They should understand the study and follow its rules, have tried other gMG treatments without enough improvement, and be on a stable dose of current medications for at least a month. Participants must use birth control if applicable.
What is being tested?
The study tests Efgartigimod PH20 SC in kids with gMG to find the right dose based on how their body absorbs and responds to it. It involves injections of this drug, monitoring over up to 14 weeks, followed by an optional extension phase for further observation.
What are the potential side effects?
While specific side effects are not listed here, participants will be closely monitored for any adverse reactions related to Efgartigimod PH20 SC throughout the trial period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 17 years old.
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I have been diagnosed with Myasthenia Gravis and have positive tests for specific antibodies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an autoimmune disease or condition that could affect my Myasthenia Gravis assessment.
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I am pregnant, breastfeeding, or plan to become pregnant during the study.
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I have been part of an efgartigimod study and received at least one dose.
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My condition did not improve after plasma exchange treatment.
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I have had or plan to have a surgery to remove my thymus gland soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Absolute value of Quantitative Myasthenia Gravis (QMG) score
Absolute value of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score, appropriate for pediatric use
Change from baseline of Quantitative Myasthenia Gravis (QMG) score
+1 more

Side effects data

From 2023 Phase 3 trial • 207 Patients • NCT04687072
31%
Blood urine present
25%
Ecchymosis
25%
Petechiae
23%
Haematuria
16%
Contusion
15%
Epistaxis
14%
Mouth haemorrhage
13%
COVID-19
12%
Headache
11%
Purpura
10%
Gingival bleeding
10%
Injection site haemorrhage
9%
Upper respiratory tract infection
9%
Injection site bruising
7%
Injection site reaction
7%
Anaemia
7%
Oral blood blister
7%
Injection site erythema
6%
Urinary tract infection
6%
Fatigue
6%
Injection site pain
6%
Dizziness
5%
Injection site rash
5%
Hyperuricaemia
5%
Haematoma
5%
Hypertension
5%
Diarrhoea
2%
Vessel puncture site haemorrhage
2%
C-reactive protein increased
2%
Dyspepsia
2%
Arthralgia
1%
COVID-19 pneumonia
1%
Meningitis aseptic
1%
Abdominal distension
1%
Haematochezia
1%
Immune thrombocytopenia
1%
Amaurosis fugax
1%
Vitreous haemorrhage
1%
Melaena
1%
Cholecystitis acute
1%
Cerebral infarction
1%
Thrombocytopenia
1%
Urosepsis
1%
Heavy menstrual bleeding
1%
Intermenstrual bleeding
1%
Haemoglobin decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efgartigimod PH20 SC
Placebo PH20 SC

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: Efgartigimod PH20 SCExperimental Treatment1 Intervention
Participants aged 12 to \<18 years receiving efgartigimod PH20 SC treatment
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
11,004 Total Patients Enrolled
15 Trials studying Myasthenia Gravis
4,785 Patients Enrolled for Myasthenia Gravis
~8 spots leftby Sep 2026
Unbiased ResultsWe believe in providing patients with all the options.
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