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NCT04980495 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
A Phase 3 study of Generalized Myasthenia Gravis and gMG, sponsored by argenx.
- Completed
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT04980495 is a Phase 3 study of Generalized Myasthenia Gravis and gMG that has completed, run by argenx. The registered enrollment target is 69 participants, below the 129-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT04980495, a Phase 3 study of Generalized Myasthenia Gravis and gMG, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG). Participants will receive efgartigimod throughout the study. The participants will be randomized to the continuous regimen arm or to the cyclic regimen arm. The study consists of a part A (regimen comparison period) where participants will continue the treatment based on the treatment regimen arm they were assigned at randomization. Following part A, participants will enter part B (extension period) where all participants will receive efgartigimod in the continuous regimen. The study duration for participants is up to 138 weeks.
Conditions Studied
Interventions
- BIOLOGICAL Efgartigimod IV
Study Locations (20)
Other
- Investigator Site 26 - AT0430002 - Innsbruck
- Investigator Site 27 - AT0430001 - Vienna
- Investigator Site 28 - BE0320001 - Leuven
- Investigator Site 29 - CA0019003 - London
- Investigator site 37 - CA0019002 - Québec
- Investigator Site 23 - FR0330005 - Bordeaux
- Investigator Site 24 - FR0330004 - Lille
- Investigator Site 20 - FR0330001 - Marseille
California
- Investigator Site 10 - US0010007 - Carlsbad
- Investigator Site 7 - US0010001 - Orange
Florida
- Investigator Site 9 - 0010006 - Boca Raton
- Investigator Site 15 - US0010014 - Coral Springs
Illinois
- Investigator Site 8 - US0010003 - Chicago
- Investigator Site 6 - US0010008 - Meadows
Georgia
- Investigator Site 16 - US0010009 - Augusta
Kansas
- Investigator Site 12 - US0010004 - Kansas City
Oregon
- Investigator Site 13 - US0010013 - Portland
Pennsylvania
- Investigator Site 17 - US0010012 - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2021-12-16 |
| Est. Completion | 2025-10-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04980495
The ClinicalTrials.gov registry entry for NCT04980495 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (47% lower). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention - of which Efgartigimod IV is the first listed.
NCT04980495 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04980495 about?
NCT04980495 is a clinical study titled "An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis". The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG). Participants will receive efgartigimod throughout the study. The participant...
What is the current status of trial NCT04980495?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2021-12-16. Estimated completion is 2025-10-06.
What conditions does trial NCT04980495 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis, gMG, MG - Myasthenia Gravis.
What interventions are being tested in trial NCT04980495?
The interventions under investigation include: Efgartigimod IV (BIOLOGICAL).
Who is sponsoring clinical trial NCT04980495?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04980495 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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