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ACTIVE NOT RECRUITING 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

NCT06298552 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 119 participants
Start Date 2024-04-16
Est. Completion 2027-06
Phase Phase 3

Sponsor

argenx

96 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06298552

The ClinicalTrials.gov registry entry for NCT06298552 describes a study currently listed as active not recruiting. 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 119 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 4 conditions, with Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions — 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: NCT06298552 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, North Carolina, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06298552?

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

Who is sponsoring clinical trial NCT06298552?

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 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.

Related

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