🏛️ Verified NIH Record • Updated 2026-08-06

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)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: argenx

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (9 items).

Location: HonorHealth Neurology - Bob Bove Neuroscience Institute — Scottsdale, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or puts the participant at undue risk
  • History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer
  • Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
  • History of or current alcohol, drug, or medication abuse as assessed by the investigator
  • Pregnant or lactating state or intention to become pregnant during the study
  • Live or live-attenuated vaccine received \<4 weeks before screening
  • Worsening muscle weakness secondary to concurrent infections or medications
  • Received a thymectomy less than 3 months before screening or thymectomy is planned during the study The complete list of exclusion criteria can be found in the protocol.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (91 Sites)

Showing the first 25 of 91 sites.

  • HonorHealth Neurology - Bob Bove Neuroscience Institute — Scottsdale, Arizona
  • Loma Linda University Health — Fresno, California
  • First Choice Neurology Boca Raton — Boca Raton, Florida
  • SFM Clinical Research LLC — Boca Raton, Florida
  • The Neurology Institute / Healthcare Innovations Institute - Coral Springs — Coral Springs, Florida
  • Neurology Associates PA — Maitland, Florida
  • Desai Sethi Medical Center — Miami, Florida
  • Medsol Clinical Research Center Inc — Port Charlotte, Florida
  • BayCare - St. Anthony's Hospital — St. Petersburg, Florida
  • University of South Florida (USF) Health - Morsani Center for Advanced Healthcare — Tampa, Florida
  • Wellstar - Augusta University Medical Center — Augusta, Georgia
  • Kansas University Medical Center - Kansas City — Fairway, Kansas
  • Rutgers-Robert Wood Johnson Medical School — New Brunswick, New Jersey
  • University of North Carolina - Chapel Hill — Chapel Hill, North Carolina
  • Duke University School of Medicine - Duke Early Phase Clinical Research Unit — Durham, North Carolina
  • Cleveland Clinic — Cleveland, Ohio
  • Erlanger Neuroscience Institute — Chattanooga, Tennessee
  • National Neuromuscular Research Institute — Austin, Texas
  • University of Washington Medical Center - Montlake — Seattle, Washington
  • Hôpital Erasme — Anderlecht,
  • Cliniques Universitaires Saint-Luc — Brussels,
  • AZ Sint-Lucas Gent — Ghent,
  • UZ Leuven — Leuven,
  • Heritage Medical Research Clinic — Calgary,
  • Genge Partners Inc. — Montreal,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Generalized Myasthenia Gravis

Explore by condition: All Generalized Myasthenia Gravis clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗