Trial · NCT03770403

A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.

NCT03770403, Phase 3, Completed, argenx; results first posted 2023-07-14

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. Trials, record NCT03770403. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03770403

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
NCT number: NCT03770403
Status: Completed
Phases: Phase 3
Enrollment: 151 participants, actual
Lead sponsor: argenx
Conditions: Generalized Myasthenia Gravis
Interventions: ARGX-113
First posted: 2018-12-10
Last updated: 2023-07-14
Other registries' IDs: eudract:2018-002133-37
Results first posted: 2023-07-14

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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 Participants	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 death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant.
Secondary	Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population	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 considered as TEAEs. An SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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 Participants	TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years	The Safety Analysis set consisted of all participants who rolled over from ARGX-113-1704 and received \>=1 dose or part of a dose of efgartigimod in this study. Only those participants with AChR-positive status are included in this analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population	TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years	The Safety Analysis set consisted of all participants who rolled over from ARGX-113-1704 and received \>=1 dose or part of a dose of efgartigimod in this study.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
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 Participants	Efgartigimod	TEAE	92	Participants
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 Participants	Efgartigimod	Treatment-emergent SAE	28	Participants
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 Participants	Efgartigimod	TEAEs leading to study drug discontinuation	10	Participants
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 Participants	Efgartigimod	Fatal TEAE	4	Participants
Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population	Efgartigimod	TEAE	124	Participants
Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population	Efgartigimod	Treatment-emergent SAE	36	Participants
Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population	Efgartigimod	TEAEs leading to study drug discontinuation	12	Participants
Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population	Efgartigimod	Fatal TEAE	5	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Efgartigimod	145
Overall Study	COMPLETED	Efgartigimod	28
Overall Study	NOT COMPLETED	Efgartigimod	117

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Efgartigimod	13	145	18
other	Nausea	Gastrointestinal disorders	Efgartigimod	9	145	13
other	Pyrexia	General disorders	Efgartigimod	11	145	11
other	COVID-19	Infections and infestations	Efgartigimod	16	145	16
other	Nasopharyngitis	Infections and infestations	Efgartigimod	20	145	24
other	Urinary tract infection	Infections and infestations	Efgartigimod	12	145	18
other	Arthralgia	Musculoskeletal and connective tissue disorders	Efgartigimod	12	145	15
other	Headache	Nervous system disorders	Efgartigimod	36	145	103
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Efgartigimod	8	145	8
other	Hypertension	Vascular disorders	Efgartigimod	8	145	10

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Efgartigimod	5	145
Total, other adverse events	Efgartigimod	83	145
Total, serious adverse events	Efgartigimod	36	145

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34146511	DERIVED	PubMed
38318236	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03770403

GET https://conductscience.org/api/trials/v1/NCT03770403/events?page=2

API reference For AI assistants