Trial · NCT03669588
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
NCT03669588, Phase 3, Completed, argenx; results first posted 2022-02-08
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. Trials, record NCT03669588. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03669588
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
- NCT number
- NCT03669588
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 167 participants, actual
- Lead sponsor
- argenx
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- ARGX-113, Placebo
- First posted
- 2018-09-13
- Last updated
- 2022-02-08
- Other registries' IDs
- eudract:2018-002132-25
- Results first posted
- 2022-02-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population | Baseline up to Day 63 (end of TC1) | The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity. A patient was considered an MG-ADL responder during C1 if there was a reduction of ≥2 points on the MG-ADL total score (compared to baseline of C1 \[C1B\]) for ≥4 consecutive weeks with the first reduction occurring no later than 1 week after the last infusion of IMP in C1. |
| Secondary | Percentage of Quantitative Myasthenia Gravis (QMG) Responders During C1; Analyzed in the AChR-Ab Seropositive Population | Baseline up to Day 63 (end of TC1) | The QMG scale quantifies disease severity based on impairments of body functions and structures as defined by the International Classification of Disability and Health. The QMG scale consists of 13 items that measure endurance or fatigability, and accounts for fluctuations in disease state. The QMG total score range is 0-39, with higher scores indicative of greater disease severity. A patient was considered a QMG responder during C1 if there was a reduction of ≥3-points on the QMG total score (compared to C1B) for ≥4 consecutive weeks with the first reduction occurring no later than 1 week after the last infusion of IMP in C1. |
| Secondary | Percentage of MG-ADL Responders During C1; Analyzed in the Overall Population | Baseline up to Day 63 (end of TC1) | The percentage of MG-ADL responders during C1 in the overall population is reported for this secondary end point; percentage of MG-ADL responders during C1 in the AChR-Ab seropositive population is reported previously as a primary end point. |
| Secondary | Percentage of Time That Patients Had a Clinically Meaningful Improvement (CMI) in MG-ADL Total Score up to and Including Day 126; Analyzed in the AChR-Ab Seropositive Population | Baseline up to Day 126 | An MG-ADL CMI was defined as a reduction of ≥2 points on the total MG-ADL score compared to study entry baseline (SEB). |
| Secondary | Time From Week 4 to Qualify for Retreatment; Analyzed in the AChR-Ab Seropositive Population | Week 4 up to Day 182 (end of study [EoS]) | Time to qualify for retreatment was defined as time from the Week 4 assessment until the first visit with a \<2-point reduction compared to SEB in the MG-ADL total score and MG-ADL total score ≥5 points with \>50% of the total score attributable to nonocular symptoms. |
| Secondary | Percentage of Early MG-ADL Responders During C1; Analyzed in the AChR-Ab Seropositive Population | Baseline up to Day 63 (end of TC1) | A patient was considered an early MG-ADL responder during C1 if there was a reduction of ≥2 points on the MG-ADL total score (compared to C1B) for ≥4 consecutive weeks with the first reduction occurring no later than Week 2 (ie, after 1 or maximum 2 infusions of IMP in C1). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population | Baseline up to Day 63 (end of TC1) | Analysis was performed in the AChR-Ab seropositive population using the modified intention-to-treat (mITT) analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Quantitative Myasthenia Gravis (QMG) Responders During C1; Analyzed in the AChR-Ab Seropositive Population | Baseline up to Day 63 (end of TC1) | Analysis was performed in the AChR-Ab seropositive population using the mITT analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint. | percentage of patients | NUMBER |
| SECONDARY | Percentage of MG-ADL Responders During C1; Analyzed in the Overall Population | Baseline up to Day 63 (end of TC1) | Analysis was performed in the overall population (including both AChR-Ab seropositive and seronegative patients) using the mITT analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Time That Patients Had a Clinically Meaningful Improvement (CMI) in MG-ADL Total Score up to and Including Day 126; Analyzed in the AChR-Ab Seropositive Population | Baseline up to Day 126 | Analysis was performed in the AChR-Ab seropositive population using the mITT analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint. | percentage of time | LEAST_SQUARES_MEAN |
| SECONDARY | Time From Week 4 to Qualify for Retreatment; Analyzed in the AChR-Ab Seropositive Population | Week 4 up to Day 182 (end of study [EoS]) | Analysis was performed in the AChR-Ab seropositive population using the mITT analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint. | days | MEDIAN |
| SECONDARY | Percentage of Early MG-ADL Responders During C1; Analyzed in the AChR-Ab Seropositive Population | Baseline up to Day 63 (end of TC1) | Analysis was performed in the AChR-Ab seropositive population using the mITT analysis set which included all randomized patients with a value for the MG-ADL total score at baseline and at least 1 postbaseline timepoint. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population | ARGX-113 | 67.7 | percentage of patients | ||
| Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population | Placebo | 29.7 | percentage of patients | ||
| Percentage of Quantitative Myasthenia Gravis (QMG) Responders During C1; Analyzed in the AChR-Ab Seropositive Population | ARGX-113 | 63.1 | percentage of patients | ||
| Percentage of Quantitative Myasthenia Gravis (QMG) Responders During C1; Analyzed in the AChR-Ab Seropositive Population | Placebo | 14.1 | percentage of patients | ||
| Percentage of MG-ADL Responders During C1; Analyzed in the Overall Population | ARGX-113 | 67.9 | percentage of patients | ||
| Percentage of MG-ADL Responders During C1; Analyzed in the Overall Population | Placebo | 37.3 | percentage of patients | ||
| Percentage of Time That Patients Had a Clinically Meaningful Improvement (CMI) in MG-ADL Total Score up to and Including Day 126; Analyzed in the AChR-Ab Seropositive Population | ARGX-113 | 48.714 | Standard Error 6.163 | percentage of time | |
| Percentage of Time That Patients Had a Clinically Meaningful Improvement (CMI) in MG-ADL Total Score up to and Including Day 126; Analyzed in the AChR-Ab Seropositive Population | Placebo | 26.649 | Standard Error 6.316 | percentage of time | |
| Time From Week 4 to Qualify for Retreatment; Analyzed in the AChR-Ab Seropositive Population | ARGX-113 | 35.0 | 95% Confidence Interval 29.0 to 43.0 | days | |
| Time From Week 4 to Qualify for Retreatment; Analyzed in the AChR-Ab Seropositive Population | Placebo | 8.0 | 95% Confidence Interval 1.0 to 30.0 | days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 | 84 | |
| Overall Study | STARTED | Placebo | 83 | |
| Overall Study | COMPLETED | ARGX-113 | 80 | |
| Overall Study | COMPLETED | Placebo | 76 | |
| Overall Study | NOT COMPLETED | ARGX-113 | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events48
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 | ARGX-113 | 6 | 84 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 9 | 83 | 14 |
| other | Nausea | Gastrointestinal disorders | ARGX-113 | 7 | 84 | 7 |
| other | Nausea | Gastrointestinal disorders | Placebo | 9 | 83 | 15 |
| other | Bronchitis | Infections and infestations | ARGX-113 | 5 | 84 | 6 |
| other | Bronchitis | Infections and infestations | Placebo | 2 | 83 | 2 |
| other | Nasopharyngitis | Infections and infestations | ARGX-113 | 10 | 84 | 12 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 15 | 83 | 17 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | ARGX-113 | 5 | 84 | 6 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Placebo | 1 | 83 | 3 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARGX-113 | 0 | 84 |
| Total, all-cause mortality | Placebo | 0 | 83 |
| Total, other adverse events | ARGX-113 | 49 | 84 |
| Total, other adverse events | Placebo | 48 | 83 |
| Total, serious adverse events | ARGX-113 | 4 | 84 |
| Total, serious adverse events | Placebo | 7 | 83 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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/NCT03669588
GET https://conductscience.org/api/trials/v1/NCT03669588/events?page=2