Actively Recruiting
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
115
Participants Needed
12
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).
CONDITIONS
Official Title
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically stable based on physical exam, medical history, vital signs, lab tests, and ECG at screening
- Diagnosis of generalized myasthenia gravis with muscle weakness as defined by MGFA class II a/b, III a/b, or IV a/b at screening
- Positive for acetylcholine receptor antibodies
- MG-ADL score of 5 or higher with less than 50% of symptoms from ocular MG-ADL sub-scores at screening and baseline
- For Arms 1 and 2: Suboptimal response to current stable therapy or discontinued corticosteroids/immunosuppressants at least 4 weeks prior to baseline
- For Arm 3: Treatment with efgartigimod IV or SC for at least 1 cycle consistent with product information
You will not qualify if you...
- Any confirmed or suspected immunodeficiency syndrome unrelated to gMG treatment, or family history of congenital/hereditary immunodeficiency unless confirmed absent
- Thymectomy within 1 year prior to baseline or planned during study
- Current malignancy or history of malignancy within 3 years before baseline
- For Arms 1 and 2: Prior treatment with FcRn-targeting therapy
- For Arm 3: Currently taking IgG monoclonal antibody therapeutics or Fc-conjugated agents except efgartigimod
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
The Neurology Group
Pomona, California, United States, 91767
Actively Recruiting
2
Advanced Neurology of Colorado
Fort Collins, Colorado, United States, 80528
Actively Recruiting
3
University of Connecticut
Farmington, Connecticut, United States, 06030
Actively Recruiting
4
SFM Clinical Research LLC
Boca Raton, Florida, United States, 33487
Actively Recruiting
5
HSHS St. Elizabeth's Hospital
O'Fallon, Illinois, United States, 62269
Actively Recruiting
6
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
7
Velocity Clinical Research, Inc.
Raleigh, North Carolina, United States, 27607 6010
Actively Recruiting
8
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
9
Texas Neurology
Dallas, Texas, United States, 75206
Actively Recruiting
10
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
11
Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
12
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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