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Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

Study acronym: ADAPT Jr +
StatusEnrolling by Invitation
PhasePhase 2/3
Sponsorargenx
Started2022-08-18
View on ClinicalTrials.gov ↗

Amendment history

2026-04-22
Study Status v18
Re-verified, no change to tracked fields
2026-01-29
Study Status, Contacts/Locations v17
Study sites15→16
2025-12-15
Study Status, Contacts/Locations v16
Study sites12→15
2025-11-17
Study Status, Study Description, Conditions, Outcome Measures, Eligibility v15
Primary completion date2028-09→2029-09
Completion date2028-09→2029-09
Eligibility criteria-689 characters
Inclusion Criteria: Participants are eligible to be included in the trial only if all of the following criteria apply: The participant completed ARGX-113-2006 or ARGX-113-2207, defined as: The participant reached End of Trial in trial [...] al regulations for those participating in clinical studies. A participant is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children. Contraceptive requirements for male participants are presented in Section 10.4.2.2. Female adolescents of childbearing potential (FAOCBP) must have a negative urine p [...] Exclu [...] [...]
Secondary endpoints4 to 2 entries
Incidence of antidrug antibodies (ADAs) against efgartigimod Prevalence of antidrug antibodies (ADAs) against efgartigimod Incidence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20) Prevalence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20)
Primary endpoints10 to 1 entries
Changes in height from baseline Changes in weight from baseline Electrocardiogram - QTcF (ms) Electrocardiogram - heart rate Incidence of adverseAEs, eventsSAEs (AEs) Incidenceand of adverse events of special interest (AESIs) Incidence of serious adverse events (SAEs) Severity of adverse events (AEs) Severity of adverse events of special interest (AESIs) Severity of serious adverse events (SAEs)
2025-08-14
Study Status, Contacts/Locations v14
Study sites11→12
Show 13 earlier versions
2025-07-16
Study Identification, Study Status, Contacts/Locations v13
Study sites10→11
Study titlerevised
[...] d Efgartigimod PH20 Administered Subcutaneously in Children withWith Generalized Myasthenia Gravis
2025-02-28
Study Identification, Study Status, Contacts/Locations v12
Study sites9→10
2025-01-23
Study Identification, Study Status, Contacts/Locations v11
Study sites8→9
Study titlerevised
[...] d Efgartigimod PH20 Administered Subcutaneously in Children Withwith Generalized Myasthenia Gravis
2024-07-15
Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v10
Trial statusRecruiting→Enrolling by Invitation
Study sites8 entries, revised
Ann and Robert H. Lurie ChildrensChildren's Hospital of Chicago - Main Hospital University of Virginia (UVA) Health - Developmental Pediatrics Clinic UZUniversitair Ziekenhuis Antwerpen LeidenLeids UniversityUniversitair MedicalMedisch CenterCentrum Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny Oxford University hospitalsHospitals NHS Foundation Trust -Oxford John Radcliffe Hospital Children's Hospital
2024-06-03
Study Status, Contacts/Locations v9
Study sites7→8
2024-04-10
Study Status, Contacts/Locations v8
Primary completion date2026-03-01→2028-09
Completion date2026-07-01→2028-09
Study sites7 entries, revised
InvestigatorAnn siteand US10120Robert H. Lurie Childrens Hospital of Chicago InvestigatorUniversity siteof US10142Virginia InvestigatorUZ siteAntwerpen Leiden BE320021University Medical Center InvestigatorWielospecjalistyczna SitePoradnia NL0310001Lekarska Synapsis InvestigatorUniwersyteckie SiteCentrum PL0480038Kliniczne WUM, Centralny Szpital Kliniczny InvestigatorOxford SiteUniversity PL0480034 Investigatorhospitals siteNHS UK0440024Foundation Trust-Oxford Children's Hospital
2024-01-09
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Study sites6→7
InterventionsEfgartigimod IV (Biological)→Efgartigimod IV or Efgartigimod PH20 SC (Biological)
Eligibility criteria-579 characters
[...] wing criteria apply: The participant completed ARGX-113-2006 or ARGX-113-2207, defined as: The participant reached endEnd of trialTrial in trial ARGX-113-2006 or End of Study in ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial. The p [...] eriod (IP) visits within the ARGX-113-2006 trial's timeframe (ie, between TPnV1 to IPnV4). Either the participant or the participant's legally acceptableauthorized representative (LAR) can understand the requirements of the trial and provide written informed consent/assent (including consent/assent for the use and disclosure of research-related he [...] [...]
Secondary endpoints2 to 4 entries
Incidence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20) Prevalence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20)
Study title+50 characters
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
2023-11-16
Study Status, Contacts/Locations v6
Study sites22→6
2023-10-09
Study Status, Contacts/Locations v5
Study sites20→22
2023-06-05
Study Status, Contacts/Locations v4
Study sites3→20
2023-01-16
Study Status, Contacts/Locations v3
Study sites1→3
2022-08-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-05-01→2026-03-01
Completion date2026-06-01→2026-07-01
Start dateestimated 2022-06-01→confirmed 2022-08-18
Study sites0→1
2022-06-02
Study Status, Outcome Measures v1
Primary endpoints12 to 10 entries
Electrocardiogram - atrioventricular nodal delay Electrocardiogram - rate-corrected QT intervals using Fridericia's formula Electrocardiogram - total duration of ventricular depolarizationQTcF (QTms)
2022-05-13
Original filing
Argenx
56 trials monitored
See 2 trials at risk
Myasthenia Gravis
187 trials monitored
See 7 trials at risk
The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively. Participants will receive efgartigimod IV or efgartigimod PH20 SC, using the dose administered in the antecedent studies. Participants who have not reached the age of 18 can remain in the study until efgartigimod becomes commercially available in the respective country or available through another continued access program for gMG. Participants who have reached the age of 18 can remain in the study for a maximum of 2 years, until efgartigimod becomes commercially available in the respective country or available through another continued access program for gMG, whichever comes first.
Trial Details
NCT Number NCT05374590
Lead Sponsor argenx
Conditions Generalized Myasthenia Gravis, gMG
Enrollment 12 participants
Start Date 2022-08-18
Primary Completion 2029-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-04-23