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
🩺 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: Review the eligibility criteria below.
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 ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
- A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis — Scottsdale, Arizona
- Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis — Orange, California
- Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis — Los Angeles, California
- Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis — Phoenix, Arizona
- A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. — Scottsdale, Arizona
Explore by condition: All Generalized Myasthenia Gravis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.