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NCT06298552 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
A Phase 3 study of Myasthenia Gravis and Generalized Myasthenia Gravis, sponsored by argenx.
- Active
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT06298552 is a Phase 3 study of Myasthenia Gravis and Generalized Myasthenia Gravis that is active but no longer recruiting, run by argenx. The registered enrollment target is 119 participants, below the 187-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT06298552, a Phase 3 study of Myasthenia Gravis and Generalized Myasthenia Gravis, is active but no longer recruiting, sponsored by argenx.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
Study Summary
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) 2.5 years.
Conditions Studied
Interventions
- BIOLOGICAL Efgartigimod IV
- OTHER Placebo IV
Study Locations (20)
Florida
- First Choice Neurology Boca Raton - Boca Raton
- SFM Clinical Research LLC - Boca Raton
- The Neurology Institute / Healthcare Innovations Institute - Coral Springs - Coral Springs
- Neurology Associates PA - Maitland
- Desai Sethi Medical Center - Miami
- Medsol Clinical Research Center Inc - Port Charlotte
- BayCare - St. Anthony's Hospital - St. Petersburg
- University of South Florida (USF) Health - Morsani Center for Advanced Healthcare - Tampa
North Carolina
- University of North Carolina - Chapel Hill - Chapel Hill
- Duke University School of Medicine - Duke Early Phase Clinical Research Unit - Durham
Arizona
- HonorHealth Neurology - Bob Bove Neuroscience Institute - Scottsdale
California
- Loma Linda University Health - Fresno
Georgia
- Wellstar - Augusta University Medical Center - Augusta
Kansas
- Kansas University Medical Center - Kansas City - Fairway
New Jersey
- Rutgers-Robert Wood Johnson Medical School - New Brunswick
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2024-04-16 |
| Est. Completion | 2027-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06298552
The ClinicalTrials.gov registry entry for NCT06298552 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 187-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (36% lower). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which Efgartigimod IV is the first listed.
NCT06298552 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, North Carolina, Arizona.
Frequently Asked Questions
What is clinical trial NCT06298552 about?
NCT06298552 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis". 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...
What is the current status of trial NCT06298552?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2024-04-16. Estimated completion is 2027-06.
What conditions does trial NCT06298552 study?
This clinical trial studies the following conditions: Myasthenia Gravis, Generalized Myasthenia Gravis, gMG, Myasthenia Gravis, Generalized.
What interventions are being tested in trial NCT06298552?
The interventions under investigation include: Efgartigimod IV (BIOLOGICAL), Placebo IV (OTHER).
Who is sponsoring clinical trial NCT06298552?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06298552 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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