Trial · NCT04735432
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
NCT04735432, Phase 3, Completed, argenx; results first posted 2023-02-28
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis. Trials, record NCT04735432. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04735432
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
- NCT number
- NCT04735432
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 110 participants, actual
- Lead sponsor
- argenx
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- efgartigimod PH20 SC, efgartigimod IV
- First posted
- 2021-02-03
- Last updated
- 2023-02-28
- Results first posted
- 2023-02-28
- Limitations and caveats
- None reported.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set) | From week 0 to week 4 | ANCOVA Analysis of Percent Change From Baseline in Total IgG Level at Day 29 (ie, 7 days after the fourth IV or SC administration). |
| Secondary | Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | From baseline to week 10 | Total IgG level percent change from baseline over time for the overall population. |
| Secondary | Percent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set) | From baseline to week 10 | Percent reduction from baseline in AChR-Ab levels over time in AChR-Ab positive patients measured in mITT Analysis Set. Descriptive statistics have been used for this secondary end point. |
| Secondary | Percent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set) | Baseline to week 10 | Median (IQR) Percent Change From Baseline for the IgG Subtypes (IgG1, IgG2, IgG3, and IgG4) in the Overall Population. The highest number of patients among all weeks for the analysis is chosen for each arm. Descriptive statistics have been used for this secondary end point. |
| Secondary | AUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set) | From baseline to week 10 | AUEC of the percent reduction from baseline total IgG per dosing interval (days 1-8, days 8-15, days 15-22, and days 22-29), days 1-29, days 1-57 and over the entire study (days 1-71). The highest number of patients among all weeks for the analysis is chosen for each arm. Descriptive statistics have been used for this secondary end point. |
| Secondary | Еfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter Ctrough | From Week 1 to Week 4. | Evaluation of observed predose concentration (Ctrough) (after all doses for the IV and SC treatment arms). The analysis will present data from Week 1 to Week 4. Descriptive statistics have been used for this secondary end point. |
| Secondary | Efgartigimod IV Serum Pharmacokinetic Parameter Cmax | From Baseline to Week 3 | Evaluation of maximum observed concentration (Cmax) (after all doses for the IV treatment arm). The analysis will present data from Baseline to Week 3. Descriptive statistics have been used for this secondary end point. |
| Secondary | Incidence of ADA Against Efgartigimod (Safety Analysis Set) | From baseline to week 10 | Incidence of antidrug antibodies (ADA) against Efgartigimod in the overall population. ADA analysis is performed with a validated ELISA in a 3-tiered approach (ADA screening analysis, confirmatory analysis and a titration assay). Descriptive statistics have been used for this secondary end point. |
| Secondary | Incidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set) | From baseline to week 10 | Incidence of antibodies against rHuPH20 in the Efgartigimod PH20 SC Arm. antibody analysis is performed with a validated ELISA in a 3-tiered approach (screening analysis, confirmatory analysis and a titration assay) Descriptive statistics have been used for this secondary end point. |
| Secondary | Incidence and Severity of AEs and SAEs (Safety Analysis Set) | From baseline to week 10 | Evaluation of incidence and severity of treatment-emergent adverse events (TEAEs) and incidence of serious AEs (SAEs). Descriptive statistics have been used for this secondary end point. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set) | From week 0 to week 4 | percent | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | From baseline to week 10 | mITT Analysis Set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline timepoint. | percent | MEAN |
| SECONDARY | Percent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set) | From baseline to week 10 | percent | MEAN | |
| SECONDARY | Percent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set) | Baseline to week 10 | mITT Analysis Set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline timepoint. | Percent change | MEDIAN |
| SECONDARY | AUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set) | From baseline to week 10 | percent days | MEAN | |
| SECONDARY | Еfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter Ctrough | From Week 1 to Week 4. | μg/mL | MEAN | |
| SECONDARY | Efgartigimod IV Serum Pharmacokinetic Parameter Cmax | From Baseline to Week 3 | μg/mL | MEAN | |
| SECONDARY | Incidence of ADA Against Efgartigimod (Safety Analysis Set) | From baseline to week 10 | Percent of patients | NUMBER | |
| SECONDARY | Incidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set) | From baseline to week 10 | Percent of patients | NUMBER | |
| SECONDARY | Incidence and Severity of AEs and SAEs (Safety Analysis Set) | From baseline to week 10 | Percent of patients | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group139
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set) | Efgartigimod PH20 SC | -66.4 | 95% Confidence Interval -68.91 to -63.86 | percent | |
| Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set) | Efgartigimod IV | -62.2 | 95% Confidence Interval -64.67 to -59.72 | percent | |
| Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | Efgartigimod PH20 SC | Week 1 | -40.1 | Standard Error 1.45 | percent |
| Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | Efgartigimod IV | Week 1 | -39.6 | Standard Error 1.51 | percent |
| Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | Efgartigimod PH20 SC | Week 2 | -56.9 | Standard Error 1.57 | percent |
| Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | Efgartigimod IV | Week 2 | -55.1 | Standard Error 1.85 | percent |
| Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | Efgartigimod PH20 SC | Week 3 | -62.2 | Standard Error 1.41 | percent |
| Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | Efgartigimod IV | Week 3 | -59 | Standard Error 2 | percent |
| Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | Efgartigimod PH20 SC | Week 4 | -64.7 | Standard Error 1.95 | percent |
| Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set) | Efgartigimod IV | Week 4 | -62.3 | Standard Error 1.24 | percent |
1 to 10 of 139Source ClinicalTrials.gov
See all 139 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Efgartigimod PH20 SC | 55 | |
| Overall Study | STARTED | Efgartigimod IV | 55 | |
| Overall Study | COMPLETED | Efgartigimod PH20 SC | 52 | |
| Overall Study | COMPLETED | Efgartigimod IV | 55 | |
| Overall Study | NOT COMPLETED | Efgartigimod PH20 SC | 3 | |
| Overall Study | NOT COMPLETED | Efgartigimod IV | 0 |
Source ClinicalTrials.gov
Adverse events42
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 | Contusion | Injury, poisoning and procedural complications | Efgartigimod PH20 SC | 0 | 55 | 0 |
| other | Contusion | Injury, poisoning and procedural complications | Efgartigimod IV | 3 | 55 | 3 |
| other | Fall | Injury, poisoning and procedural complications | Efgartigimod PH20 SC | 1 | 55 | 1 |
| other | Fall | Injury, poisoning and procedural complications | Efgartigimod IV | 3 | 55 | 3 |
| other | Headache | Nervous system disorders | Efgartigimod PH20 SC | 7 | 55 | 10 |
| other | Headache | Nervous system disorders | Efgartigimod IV | 7 | 55 | 11 |
| other | Myasthenia gravis | Nervous system disorders | Efgartigimod PH20 SC | 6 | 55 | 8 |
| other | Myasthenia gravis | Nervous system disorders | Efgartigimod IV | 1 | 55 | 2 |
| other | Fatigue | General disorders | Efgartigimod PH20 SC | 2 | 55 | 2 |
| other | Fatigue | General disorders | Efgartigimod IV | 3 | 55 | 3 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efgartigimod PH20 SC | 0 | 55 |
| Total, all-cause mortality | Efgartigimod IV | 0 | 55 |
| Total, other adverse events | Efgartigimod PH20 SC | 37 | 55 |
| Total, other adverse events | Efgartigimod IV | 23 | 55 |
| Total, serious adverse events | Efgartigimod PH20 SC | 8 | 55 |
| Total, serious adverse events | Efgartigimod IV | 4 | 55 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Efgartigimod PH20 SC vs Efgartigimod IV: deaths from any cause | Trial comparisons |
| Efgartigimod PH20 SC vs Efgartigimod IV: 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/NCT04735432
GET https://conductscience.org/api/trials/v1/NCT04735432/results?page=2