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COMPLETED Phase 3

An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

NCT04980495 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 69 participants
Start Date 2021-12-16
Est. Completion 2025-10-06
Phase Phase 3

Sponsor

argenx

96 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04980495 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04980495?

The interventions under investigation include: Efgartigimod IV (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04980495?

This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial