Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
Public ClinicalTrials.gov record NCT04735432. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod 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 investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)
Study identification
- NCT ID
- NCT04735432
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 110 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
- Feb 4, 2021
- Primary completion
- Nov 1, 2021
- Completion
- Dec 12, 2021
- Last update posted
- Feb 27, 2023
2021
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator site 2 - US0010032 | Carlsbad | California | 92011 | — |
| Investigator Site 41 - US0010004 | Orange | California | 92868 | — |
| Investigator site 2 - US0010108 | Boca Raton | Florida | 33428 | — |
| Investigator site 1 - US0010110 | Port Charlotte | Florida | 33952 | — |
| Investigator Site 27 - US0010006 | Tampa | Florida | 41076 | — |
| Investigator Site 47 - US0010113 | Augusta | Georgia | 30912 | — |
| Investigator Site 42 - US0010015 | Kansas City | Kansas | 66205 | — |
| Investigator Site 11 - US0010111 | Amherst | New York | 14226 | — |
| Investigator Site 40 - US0010003 | Chapel Hill | North Carolina | 27514 | — |
| Investigator Site 38 - US0010077 | Durham | North Carolina | 27710 | — |
| Investigator Site 43 - 0010019 | Cleveland | Ohio | 44195 | — |
| Investigator site 4 - US0010008 | Cordova | Tennessee | 38018 | — |
| Investigator Site 28 - US0010066 | Austin | Texas | 78756 | — |
| Investigator Site 46 - US0010009 | Texas City | 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 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04735432, 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 Feb 27, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04735432 live on ClinicalTrials.gov.