Trial · NCT06298552
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
NCT06298552, Phase 3, Active not recruiting, argenx
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis. Trials, record NCT06298552. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06298552
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
- NCT number
- NCT06298552
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- argenx
- Conditions
- Generalized Myasthenia Gravis, gMG, Myasthenia Gravis, Generalized, Myasthenia Gravis
- Interventions
- Efgartigimod IV, Placebo IV
- First posted
- 2024-03-07
- Last updated
- 2026-08-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MG-ADL Total Score Change From Baseline | Up to 29 days in part A | The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms). |
| Secondary | QMG Total Score Change From Baseline | Up to 29 days in part A | The Quantitative Myasthenia Gravis (QMG) score includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no symptoms) to 39 (highest disease severity). |
| Secondary | Proportion of Participants Who Are Both MG-ADL and QMG Responders in Part A | Up to 8 weeks (part A) | A participant was an MG-ADL responder if there was a ≥2-point reduction in the MG-ADL total score compared with baseline that was maintained for at least 4 consecutive weeks (ie, at least 5 consecutive visits total), with the first reduction occurring no later than 1 week after the last administration of IMP in part A. A participant was a QMG responder if there was a ≥3-point reduction in the QMG total score compared with baseline that was maintained for at least 4 consecutive weeks (ie, at least 5 consecutive visits total), with the first reduction occurring no later than 1 week after the last administration of IMP in part A. |
| Secondary | Proportion of Participants With MSE | Up to 8 weeks (part A) + 3 years (part B) | Minimal symptom expression (MSE) is defined as an MG-ADL total score of 0 or 1 |
| Secondary | Proportion of Participants Who Are MG-ADL Responders in Part A | Up to 8 weeks (part A) | The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms). A participant was an MG-ADL responder if there was a ≥2-point reduction in the MG-ADL total score compared with baseline that was maintained for at least 4 consecutive weeks (ie, at least 5 consecutive visits total), with the first reduction occurring no later than 1 week after the last administration of IMP in part A. |
| Secondary | Proportion of Participants Who Are QMG Responders in Part A | Up to 8 weeks (part A) | The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no symptoms) to 39 (highest disease severity). A participant was a QMG responder if there was a ≥3-point reduction in the QMG total score compared with baseline that was maintained for at least 4 consecutive weeks (ie, at least 5 consecutive visits total), with the first reduction occurring no later than 1 week after the last administration of IMP in part A. |
| Secondary | Proportion of Participants Who Are Early MG-ADL Responders in Part A | Up to 8 weeks (part A) | The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms). An Early MG-ADL responder is an MG-ADL responder who had an onset of an MG-ADL response no later than 2 weeks after the first administration of IMP in part A. |
| Secondary | MG-ADL Total Score Change From Baseline Over Time in Part A and Part A+B | Up to 8 weeks (part A) + 3 years (part B) | The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (no symptoms) to 24 (most severe symptoms). |
| Secondary | MG-QoL15r Change From Baseline Over Time in Part A and Part A+B | Up to 8 weeks (part A) + 3 years (part B) | The Myasthenia Gravis Quality of Life-15 revised (MG-QoL15r) is a patient-reported instrument that measures the impact of MG symptoms on quality of life. The total scores range from 0 (best outcome) to 30 (worst outcome). |
| Secondary | EQ-5D-5L VAS Change From Baseline Over Time in Part A and Part A+B | Up to 8 weeks (part A) + 3 years (part B) | The EQ-5D-5L is a participant-reported measure of health status developed by the EuroQol Group. The questionnaire comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Current health status is rated on vertical visual analog score (VAS) from 0 to 100, with a score of 0 corresponding to "the worst health you can imagine" and 100 corresponding to "the best health you can imagine." |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT06298552
GET https://conductscience.org/api/trials/v1/NCT06298552/registered