A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
Public ClinicalTrials.gov record NCT06298552. 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 Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 3.5 years.
Study identification
- NCT ID
- NCT06298552
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 119 participants
Conditions and interventions
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 16, 2024 (Actual)
- Primary completion
- Jun 30, 2025 (Actual)
- Completion
- Jun 2028 (Estimated)
- Last update posted
- Aug 10, 2026
2024 – 2028
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Neurology - Bob Bove Neuroscience Institute | Scottsdale | Arizona | 85251 | — |
| Loma Linda University Health | Fresno | California | 93701-2234 | — |
| First Choice Neurology Boca Raton | Boca Raton | Florida | 33428 | — |
| SFM Clinical Research LLC | Boca Raton | Florida | 33487 | — |
| The Neurology Institute / Healthcare Innovations Institute - Coral Springs | Coral Springs | Florida | 33067 | — |
| Neurology Associates PA | Maitland | Florida | 32751 | — |
| Desai Sethi Medical Center | Miami | Florida | 33136 | — |
| Medsol Clinical Research Center Inc | Port Charlotte | Florida | 33952 | — |
| BayCare - St. Anthony's Hospital | St. Petersburg | Florida | 33705-1410 | — |
| University of South Florida (USF) Health - Morsani Center for Advanced Healthcare | Tampa | Florida | 33612 | — |
| Wellstar - Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Kansas University Medical Center - Kansas City | Fairway | Kansas | 66205 | — |
| Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901-1962 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7025 | — |
| Duke University School of Medicine - Duke Early Phase Clinical Research Unit | Durham | North Carolina | 27710 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Erlanger Neuroscience Institute | Chattanooga | Tennessee | 37403-2173 | — |
| National Neuromuscular Research Institute | Austin | Texas | 78756 | — |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | — |
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 72 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06298552, 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 Aug 10, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06298552 live on ClinicalTrials.gov.