18 and older, any sex, with Generalized Myasthenia Gravis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in AChR-Positive ParticipantsPrimary· TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (electrocardiogram \[ECG\], radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of participant's last visit were considered as TEAEs. A serious AE (SAE) was any AE that resulted in deat
TEAE
Group
Value
95% CI
Efgartigimod
92
Treatment-emergent SAE
Group
Value
95% CI
Efgartigimod
28
TEAEs leading to study drug discontinuation
Group
Value
95% CI
Efgartigimod
10
Fatal TEAE
Group
Value
95% CI
Efgartigimod
4
Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall PopulationSecondary· TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years
Overall population included both AChR-Ab seropositive and AChR-Ab seronegative participants. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (ECG, radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of participant's last visit were c
TEAE
Group
Value
95% CI
Efgartigimod
124
Treatment-emergent SAE
Group
Value
95% CI
Efgartigimod
36
TEAEs leading to study drug discontinuation
Group
Value
95% CI
Efgartigimod
12
Fatal TEAE
Group
Value
95% CI
Efgartigimod
5
Adverse events — posted to ClinicalTrials.gov
Time frame: TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03669588 — An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
· Phase 3
· completed
NCT03334058 — A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus
· Phase 2
· completed
NCT03334084 — A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Sub
· Phase 1
· completed
NCT03102593 — A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP
· Phase 2
· completed
NCT02965573 — A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have G
· Phase 2
· completed
Other recruiting trials for Generalized Myasthenia Gravis
Currently open trials in the same condition.
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· Phase 2
· recruiting
NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
· Phase 4
· recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip
· recruiting
NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With
· Phase 2
· recruiting
NCT06967480 — Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
· recruiting
Other argenx trials
Trials by the same sponsor.
NCT07377396 — A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
· Phase 1
· recruiting
NCT07287982 — A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration
· Phase 2
· recruiting
NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With
· Phase 2
· recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip
· recruiting
NCT07091630 — A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by argenx
Last refreshed: 14 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03770403.