Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
Public ClinicalTrials.gov record NCT04818671. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).
Study identification
- NCT ID
- NCT04818671
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 184 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 26, 2021 (Actual)
- Primary completion
- Dec 31, 2024 (Actual)
- Completion
- Dec 31, 2024 (Actual)
- Last update posted
- Jan 22, 2026
2021 – 2024
United States locations
- U.S. sites
- 13
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator site 6 - US0010032 | Carlsbad | California | 92011 | — |
| Investigator Site 47 - US0010021 | Palo Alto | California | 94304 | — |
| Investigator Site 45 - US0010108 | Boca Raton | Florida | 33428 | — |
| Investigator site 4 - US0010110 | Port Charlotte | Florida | 33952 | — |
| Investigator Site 39 - US0010006 | Tampa | Florida | 41076 | — |
| Investigator Site 41 - US0010015 | Kansas City | Kansas | 66160 | — |
| Investigator Site 46 - US0010111 | Amherst | New York | 14226 | — |
| Investigator Site 38 - US0010003 | Chapel Hill | North Carolina | 27514 | — |
| Investigator Site 44 - US0010077 | Durham | North Carolina | 27710 | — |
| Investigator Site 42 - US0010019 | Cleveland | Ohio | 44195 | — |
| Investigator site 7 - US0010008 | Cordova | Tennessee | 38018 | — |
| Investigator Site 43 - US0010066 | Austin | Texas | 78759 | — |
| Investigator Site 40 - US0010009 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04818671, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2026 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04818671 live on ClinicalTrials.gov.