Trial · NCT02965573
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
NCT02965573, Phase 2, Completed, argenx; results first posted 2021-01-08
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. Trials, record NCT02965573. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02965573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
- NCT number
- NCT02965573
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- argenx
- Conditions
- Myasthenia Gravis
- Interventions
- ARGX-113, Placebo
- First posted
- 2016-11-17
- Last updated
- 2024-08-28
- Other registries' IDs
- eudract:2016-002938-73
- Results first posted
- 2021-01-08
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | Day 1 to Day 78 | TEAEs were defined as AEs that first occurred or worsened in severity after the first administration of the treatment. A treatment emergent SAE was any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent or significant disability or incapacity; was a congenital abnormality or birth defect; or other medically significant events. All TEAEs observed were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 with descriptions of severity for each AE based on the following general guideline: Grade 1= mild; Grade 2 = moderate; Grade 3 = severe or medically significant but not immediately life-threatening; Grade 4 = life-threatening consequences; Grade 5 = death related to AE. |
| Primary | Mean Change From Baseline in Vital Signs: Blood Pressure | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The patients' diastolic and systolic blood pressure were measured pre-dose on dosing days 1,8,15 and 22 and also during the follow up period. The mean change from baseline at each time point is presented. Baseline is defined as the last non-missing value before first dose of study medication. |
| Primary | Mean Change From Baseline in Vital Signs: Heart Rate | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The patients' heart rate was measured pre-dose on dosing days 1,8,15 and 22 and also during the follow up period. The mean change from baseline at each time point is presented. Baseline is defined as the last non-missing value before first dose of study medication. |
| Primary | Mean Change From Baseline in Vital Signs: Temperature | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The patients' temperature was measured pre-dose on dosing days 1,8,15 and 22 and also during the follow up period. The mean change from baseline at each time point is presented. Baseline is defined as the last non-missing value before first dose of study medication. |
| Primary | Mean Change From Baseline in Vital Signs: Weight | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The patients' weight as measured pre-dose on dosing days 1,8,15 and 22 and also during the follow up period. The mean change from baseline at each time point is presented. Baseline is defined as the last non-missing value before first dose of study medication. |
| Primary | Number of Patients With Abnormal Clinically Relevant Findings in Electrocardiogram (ECG) Parameters | Day 1 to Day 78 | ECG parameters of heart rate, PR, QT, and QRS interval were read locally and performed pre-dose on dosing days 1,8,15 and 22 and on the last follow up visit on Day 78. Any patients recording abnormal clinically relevant findings during the study are presented. |
| Primary | Number of Patients With Abnormal Clinical Laboratory Findings Reported as TEAEs | Day 1 to Day 78 | Sampling for clinical laboratory tests including hematology, clinical chemistry, and urinalysiswas performed pre-dose on dosing Days 1, 8, 15 and 22 and throughout the follow up period. Patients fasted for at least 8 hours prior to this sampling. Abnormal laboratory values, or test results were not reported as TEAEs unless they were associated with clinical signs and symptoms that were considered clinically relevant, required therapy or led to treatment discontinuation. Patients reporting TEAEs in any of the laboratory parameters during the study are presented. |
| Secondary | Mean Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. It evaluates the capacity to perform different activities of daily living such as talking, chewing, swallowing, breathing, brushing the teeth/combing the hair, or arising from the chair and it also assesses double vision and eyelid droop. The 8 items are rated from 0 to 3 and the total score could point from 0 to 24; with higher scores indicating more impairment. The mean change in MG-ADL score from baseline is presented for each timepoint with a clinically meaningful improvement defined as a drop of at least 2 points as compared with baseline. |
| Secondary | Mean Change From Baseline in QMG Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The QMG quantifies disease severity based on impairments of body functions and structures as defined by the International Classification of Disability and Health. The QMG consists of 13 items that includes ocular, bulbar, and limb function. Out of the 13 items, 6 are timed tests of endurance measured in seconds. Each item has a possible score from 0-3. The score range is 0-39, where higher scores indicate more severe impairments. The mean change in QMG score from baseline is presented with a clinically meaningful improvement defined as a drop of at least 3 points as compared with baseline. |
| Secondary | Mean Change From Baseline in MGC Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The MGC has 10 items combining physician examination and patient-reported outcomes. The 2 ocular items are derived from QMG. It has 3 items on muscle strength (deltoids, hip flexors, and neck flexors or extensors) and 4 items on bulbar function (swallowing, chewing, breathing, and speech functions), based on the clinical history. Each item is scored on an ordinal scale with 4 possible categories, but the items are weighted, whereby bulbar impairments weigh more than ocular ones. The impairments that were examined by the Investigator included ptosis or upward gaze, double vision, eye closure, neck flexion, shoulder abduction, and hip flexion. The patient-reported outcomes under MGC are talking, chewing, swallowing, and breathing. The maximum possible score is 50 (range from 0-50), with higher scores reflecting more severe impairments. The mean change in MGC score from baseline is presented. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | Day 1 to Day 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline in Vital Signs: Blood Pressure | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received.~Only patients with data available for analysis are presented. | millimeters mercury | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs: Heart Rate | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received.~Only patients with data available for analysis are presented. | beats/minute | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs: Temperature | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received.~Only patients with data available for analysis are presented. | degrees Centigrade | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs: Weight | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received.~Only patients with data available for analysis are presented. | kg | MEAN |
| PRIMARY | Number of Patients With Abnormal Clinically Relevant Findings in Electrocardiogram (ECG) Parameters | Day 1 to Day 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Abnormal Clinical Laboratory Findings Reported as TEAEs | Day 1 to Day 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The full analysis set (FAS) included all randomized patients with at least 1 of the MG-ADL, Quantitative Myasthenia Gravis (QMG), Myasthenia Gravis Composite (MGC), and 15-item Quality of Life scale for Myasthenia Gravis revised version (MGQoL15r) scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. Only patients with data available for analysis are presented. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in QMG Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. Only patients with data available for analysis are presented. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in MGC Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. Only patients with data available for analysis are presented. | score on a scale | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group240
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | ARGX-113 | At least 1 TEAE | 10 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | Placebo | At least 1 TEAE | 10 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | ARGX-113 | At least 1 treatment-related TEAE | 8 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | Placebo | At least 1 treatment-related TEAE | 3 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | ARGX-113 | At least 1 treatment emergent SAE | 0 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | Placebo | At least 1 treatment emergent SAE | 0 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | ARGX-113 | Withdrawn from treatment with at least 1 TEAE | 0 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | Placebo | Withdrawn from treatment with at least 1 TEAE | 0 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | ARGX-113 | Discontinued study due to at least 1 TEAE | 0 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | Placebo | Discontinued study due to at least 1 TEAE | 0 | Participants |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ARGX-113 | 12 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | ARGX-113 | 11 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | ARGX-113 | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events98
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 | Abdominal pain upper | Gastrointestinal disorders | ARGX-113 | 1 | 12 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 12 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | ARGX-113 | 1 | 12 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 12 | 3 |
| other | Nausea | Gastrointestinal disorders | ARGX-113 | 1 | 12 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 12 | 1 |
| other | Toothache | Gastrointestinal disorders | ARGX-113 | 0 | 12 | 0 |
| other | Toothache | Gastrointestinal disorders | Placebo | 2 | 12 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | ARGX-113 | 1 | 12 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 12 | 0 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARGX-113 | 0 | 12 |
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, other adverse events | ARGX-113 | 10 | 12 |
| Total, other adverse events | Placebo | 10 | 12 |
| Total, serious adverse events | ARGX-113 | 0 | 12 |
| Total, serious adverse events | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ARGX-113 vs Placebo: Number of Patients With Abnormal Clinically Relevant Findings in Electrocardiogram (ECG) Parameters | Trial comparisons |
| ARGX-113 vs Placebo: deaths from any cause | Trial comparisons |
| ARGX-113 vs Placebo: serious adverse events | Trial comparisons |
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/NCT02965573
GET https://conductscience.org/api/trials/v1/NCT02965573/registered?page=2