Generalized Myasthenia GravisPhase 2/3ADAPT Jr SCNCT06392386
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
A Phase 2/3 study testing Efgartigimod PH20 SC in people with Generalized Myasthenia Gravis, run by argenx at 22 sites in 14 countries.
Trial summary
The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- Efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 22 sitesin 14 countries
- Study dates
- 28 Jun 2024to Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participant (and/or their legally authorized representative) understands the requirements of the study and is capable of providing written informed consent/assent and complying with protocol requirements
- The participant is aged 2 to <18 years at the time of informed consent/assent
- The participant has been diagnosed with generalised Myasthenia Gravis that is supported by a physical examination and confirmed seropositivity for anti-acetylcholine receptor antibodies
- The participant has had an unsatisfactory response to immunosuppressants, corticosteroids, or acetylcholinesterase inhibitors but is on stable concomitant MG therapy. If receiving corticosteroids and/or immunosuppressants, must be on a stable dose for ≥1 month before screening
- The participant agrees to use birth control consistent with local regulations and people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
Who cannot join
- Is a female adolescent of child-bearing potential who is pregnant and/or lactating or intends to become pregnant during their participation in the study
- Has worsening muscle weakness secondary to a concurrent infection or as a result of a medication
- Has a documented lack of clinical response to plasma exchange (PLEX)
- Received a live or live-attenuated vaccine within <4 weeks before screening
- Received a thymectomy within 3 months before screening or is planning to get a thymectomy during their participation in the study
- Has a 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
Show all 17Show fewer
- History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer
- Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
- Has a positive PCR test for SARS-CoV-2 at screening
- Has/had a clinically significant disease, had recent major surgery (within 3 months of screening) or intends to have major surgery during the study, or has/had any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Has received a different study drug in another clinical study within <12 before screening
- Is currently participating in another interventional clinical study
- Has previously participated in an efgartigimod clinical study and received at least one dose of study drug
- Has a known hypersensitivity to study drug or any of its excipients
- Has a history of or current episode of alcohol, drug, or medication abuse as assessed by the investigator
- Use of some medications before screening (more information is found in the protocol)
- The complete list of exclusion criteria can be found in the protocol.
Trial locations and contacts
22 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 14 countries
United States3 sites
- Active, not recruiting
Carolinas HealthCare System Neurosciences Institute - Neurology
Charlotte, North Carolina, 28207
- Active, not recruiting
University of Virginia
Charlottesville, Virginia, 22903
- Active, not recruiting
Neurology Rare Disease Center
Denton, Texas, 76208
Israel3 sites, 3 recruiting
- Recruiting
Hadassah Medical Center- Ein Kerem
Jerusalem, 9112001
Talya Dor-Wollman, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikvah, 4920235
Yoram Nevo, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv, 6423906
Liora Sagi, MD, 857-350-4834, clinicaltrials@argenx.com
Poland3 sites, 3 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk, 80-211
Maria Mazurkiewicz-Beldzinska, MD, +48583492390, mmazur@gumed.edu.pl
- Recruiting
Neurologia Śląska Centrum Medyczne
Katowice, 40-689
Marek Smilowski, MD, +48500282494, marek.smilowski2@gmail.com
- Recruiting
Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM
Warsaw, 02-097
Anna Kostera-Pruszczyk, MD, +48225992858, anna.kostera-pruszczyk@wum.edu.pl
Australia2 sites, 2 recruiting
- Recruiting
Royal Children's Hospital Melbourne
Melbourne, New South Wales, 3052
Eppie Yiu, MD, 61 41 2599077, eppie.yiu@rch.org.au
- Recruiting
Sydney Children's Hospital
Randwick, 2031
Michelle Farrar, MD, +61293821549, michelle.farrar@health.nsw.gov.au
Czechia2 sites, 2 recruiting
- Recruiting
Fakultni nemocnice Brno
Brno, 613 00
Ondrej Havlin, MD, +42532234581, havlin.ondrej@fnbrno.cz
- Recruiting
Fakultni nemocnice Ostrava
Ostrava, 708 00
Hana Medricka, MD, +420597373612, hana.medricka@fno.cz
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent
Ghent, 9000
Nicolas Deconinck, MD, +32473966619, nicolas.deconinck@huderf.be
Canada1 site, 1 recruiting
- Recruiting
Childrens Hospital of Eastern Ontario
Ottawa, K1H 8L1
Hugh McMillan, MD, 857-350-4834, clinicaltrials@argenx.com
France1 site, 1 recruiting
- Recruiting
AP-HM- Hôpital de La Timone
Marseille, 13385
Cecile Halbert, MD, +33491385605, cecile.halbert@ap-hm.fr
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Essen
Essen, 45147
Adela Della Marina, MD, +492017233618, adela.dellamarina@uk-essen.de
Italy1 site, 1 recruiting
- Recruiting
Istituto G Gaslini Ospedale Pediatrico IRCCS
Genova, 16147
Chiara Fiorillo, MD, +3901056363566, chiarafiorillo@edu.unige.it
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333 ZA
Erik Harmen Niks, MD, +310715262197, e.h.niks@lumc.nl
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Teresa Sevilla Mantecón, MD, +34961244000, sevilla_ter@gva.es
Switzerland1 site, 1 recruiting
- Recruiting
Hôpital Nestlé
Lausanne, 1011
David Jacquier, MD, 857-350-4834, clinicaltrials@argenx.com
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Children's Hospital
Oxford, OX3 9DU
Sithara Ramdas, MD, 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: An Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod PH20 SC in Participants From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis
The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years. The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study. Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study. At the end of the follow-up period, eligible participants may roll over to an open-label extension (OLE) study.
The participants will be in the study for up to 14 weeks.
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- Efgartigimod PH20 SC
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod PH20 SCBiological
Subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod PH20 SC | Experimental | Participants aged 12 to <18 years receiving efgartigimod PH20 SC treatment Receives: Biological: Efgartigimod PH20 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Clearance (CL)
Measured: Up to 12 weeks
Efgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Volume Distribution (Vd)
Measured: Up to 12 weeks
Total G immunoglobulins (IgG) levels as input for pharmacokinetics (PK)/pharmacodynamics (PD) modelling analysis
Measured: Up to 12 weeks
Anti-acetylcholine receptors antibodies (AChR-Ab) as input for pharmacokinetics (PK)/ pharmacodynamics (PD) modelling analysis
Measured: Up to 12 weeks
Secondary outcomes (26)
Incidence of adverse events (AEs)
Measured: Up to 14 weeks
Severity of adverse events (AEs)
Measured: Up to 14 weeks
Incidence of serious adverse events (SAEs)
Measured: Up to 14 weeks
Severity of serious adverse events (SAEs)
Measured: Up to 14 weeks
Incidence of adverse events of special interest (AESI)
Measured: Up to 14 weeks
Severity of adverse events of special interest (AESI)
Measured: Up to 14 weeks
Efgartigimod serum concentrations
Measured: Up to 12 weeks
Absolute values of total Immunoglobulin G (IgG) from blood samples
Measured: Up to 12 weeks
Change from baseline values of total Immunoglobulin G (IgG) from blood samples
Measured: Up to 12 weeks
Percentage change from baseline values of total Immunoglobulin G (IgG) from blood samples
Measured: Up to 12 weeks
Absolute values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Measured: Up to 12 weeks
Change from baseline values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Measured: Up to 12 weeks
Percentage change from baseline values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Measured: Up to 12 weeks
Incidence of anti-drug antibodies (ADAs) against efgartigimod in serum samples
Measured: Up to 12 weeks
Prevalence of anti-drug antibodies (ADAs) against efgartigimod in serum samples
Measured: Up to 12 weeks
Incidence of antibodies against rHuPH20 in serum samples
Measured: Up to 12 weeks
Prevalence of antibodies against rHuPH20 in serum samples
Measured: Up to 12 weeks
Absolute value of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score, appropriate for pediatric use
Minimum value: 0 (no impairment); Maximum value: 24 (highest impairment)
Measured: Up to 12 weeks
Change from baseline of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score, appropriate for pediatric use
Minimum value: 0 (no impairment); Maximum value: 24 (highest impairment)
Measured: Up to 12 weeks
Absolute value of Quantitative Myasthenia Gravis (QMG) score
Minimum value: 0 (no impairment); Maximum value: 39 (most severe impairment)
Measured: Up to 12 weeks
Change from baseline of Quantitative Myasthenia Gravis (QMG) score
Minimum value: 0 (no impairment); Maximum value: 39 (most severe impairment)
Measured: Up to 12 weeks
Absolute value of EuroQoL 5 Dimensions Youth (EQ-5D-Y) score
Measured: Up to 12 weeks
Change from baseline value of Neuro-QoL Pediatric Fatigue Score
Measured: Up to 12 weeks
Change from baseline value of EuroQoL 5 Dimensions Youth (EQ-5D-Y) score
Measured: Up to 12 weeks
Change from baseline value of Clinical Global Impression of Improvement (CGI-I)
Measured: Up to 12 weeks
Changes in protective antibody titers to vaccines
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start28 Jun 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392386
- Sponsor's protocol ID
- ARGX-113-2207
- Other IDs
- 2023-506159-12-00, 2023
- Acronym
- ADAPT Jr SC
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod PH20 SC in Participants From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT06392386
- Acronym / sponsor ID
- ADAPT Jr SC / ARGX-113-2207
- Conditions
- Generalized Myasthenia Gravis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years. The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study. Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study. At the end of the follow-up period, eligible participants may roll over to an open-label extension (OLE) study.
The participants will be in the study for up to 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod PH20 SC | Experimental | Biological: Efgartigimod PH20 SCParticipants aged 12 to <18 years receiving efgartigimod PH20 SC treatment |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The participant (and/or their legally authorized representative) understands the requirements of the study and is capable of providing written informed consent/assent and complying with protocol requirements
- The participant is aged 2 to <18 years at the time of informed consent/assent
- The participant has been diagnosed with generalised Myasthenia Gravis that is supported by a physical examination and confirmed seropositivity for anti-acetylcholine receptor antibodies
- The participant has had an unsatisfactory response to immunosuppressants, corticosteroids, or acetylcholinesterase inhibitors but is on stable concomitant MG therapy. If receiving corticosteroids and/or immunosuppressants, must be on a stable dose for ≥1 month before screening
- The participant agrees to use birth control consistent with local regulations and people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
Key exclusion criteria (17 listed)
- Is a female adolescent of child-bearing potential who is pregnant and/or lactating or intends to become pregnant during their participation in the study
- Has worsening muscle weakness secondary to a concurrent infection or as a result of a medication
- Has a documented lack of clinical response to plasma exchange (PLEX)
- Received a live or live-attenuated vaccine within <4 weeks before screening
- Received a thymectomy within 3 months before screening or is planning to get a thymectomy during their participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efgartigimod PH20 SCSubcutaneous injections | Biological | Efgartigimod PH20 SC |
Primary outcome
Efgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Clearance (CL)
Time frame: Up to 12 weeks
Efgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Volume Distribution (Vd)
Time frame: Up to 12 weeks
Total G immunoglobulins (IgG) levels as input for pharmacokinetics (PK)/pharmacodynamics (PD) modelling analysis
Time frame: Up to 12 weeks
Anti-acetylcholine receptors antibodies (AChR-Ab) as input for pharmacokinetics (PK)/ pharmacodynamics (PD) modelling analysis
Time frame: Up to 12 weeks
26 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 14 weeks
Severity of adverse events (AEs)
Time frame: Up to 14 weeks
Incidence of serious adverse events (SAEs)
Time frame: Up to 14 weeks
Severity of serious adverse events (SAEs)
Time frame: Up to 14 weeks
Incidence of adverse events of special interest (AESI)
Time frame: Up to 14 weeks
Severity of adverse events of special interest (AESI)
Time frame: Up to 14 weeks
Efgartigimod serum concentrations
Time frame: Up to 12 weeks
Absolute values of total Immunoglobulin G (IgG) from blood samples
Time frame: Up to 12 weeks
Change from baseline values of total Immunoglobulin G (IgG) from blood samples
Time frame: Up to 12 weeks
Percentage change from baseline values of total Immunoglobulin G (IgG) from blood samples
Time frame: Up to 12 weeks
Absolute values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Time frame: Up to 12 weeks
Change from baseline values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Time frame: Up to 12 weeks
Percentage change from baseline values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Time frame: Up to 12 weeks
Incidence of anti-drug antibodies (ADAs) against efgartigimod in serum samples
Time frame: Up to 12 weeks
Prevalence of anti-drug antibodies (ADAs) against efgartigimod in serum samples
Time frame: Up to 12 weeks
Incidence of antibodies against rHuPH20 in serum samples
Time frame: Up to 12 weeks
Prevalence of antibodies against rHuPH20 in serum samples
Time frame: Up to 12 weeks
Absolute value of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score, appropriate for pediatric use
Time frame: Up to 12 weeks
Change from baseline of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score, appropriate for pediatric use
Time frame: Up to 12 weeks
Absolute value of Quantitative Myasthenia Gravis (QMG) score
Time frame: Up to 12 weeks
Change from baseline of Quantitative Myasthenia Gravis (QMG) score
Time frame: Up to 12 weeks
Absolute value of EuroQoL 5 Dimensions Youth (EQ-5D-Y) score
Time frame: Up to 12 weeks
Change from baseline value of Neuro-QoL Pediatric Fatigue Score
Time frame: Up to 12 weeks
Change from baseline value of EuroQoL 5 Dimensions Youth (EQ-5D-Y) score
Time frame: Up to 12 weeks
Change from baseline value of Clinical Global Impression of Improvement (CGI-I)
Time frame: Up to 12 weeks
Changes in protective antibody titers to vaccines
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Efgartigimod PH20 SC in people with Generalized Myasthenia Gravis, run by argenx at 22 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Israel, Poland, Australia, Czechia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Clearance (CL) (time frame: Up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.