Nipocalimab: Nipocalimab will be administered intravenously.
Efgartigimod: Efgartigimod will be administered intravenously.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
Inclusion criteria:
For all arms:
* Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies
* Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 5 with less than (\<) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits
Criteria specific to Arms 1 and 2 only:
\- Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and/or immunosuppressants/immunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy
Criteria specific to Arm 3:
\- Treatment with efgartigimod IV or subcutaneous (SC) for \>=1 cycle, and the final cycle is consistent with product information
Exclusion criteria:
* Any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
* Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study
* Currently has a malignancy or has a history of malignancy within 3 years before baseline
Criteria specific to Arms 1 and 2 only:
\- Has received treatment for MG with an FcRn-targeting therapy
Criteria specific to Arm 3 only:
\- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod
Primary outcome measure(s)
Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12 — Baseline, Weeks 8, 10 and 12 Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.
Trial sites (17)
Facility
City
Region
Status
Neurology Center of North Orange County
Fullerton
California
Recruiting
The Neurology Group
Pomona
California
Recruiting
Advanced Neurology of Colorado
Fort Collins
Colorado
Completed
University of Connecticut
Farmington
Connecticut
Recruiting
SFM Clinical Research LLC
Boca Raton
Florida
Recruiting
HSHS St. Elizabeth's Hospital
O'Fallon
Illinois
Recruiting
Josephson Wallack Munshower Neurology, PC
Indianapolis
Indiana
Recruiting
Tulane Center for Clinical Research
New Orleans
Louisiana
Recruiting
Henry Ford Hospital
Detroit
Michigan
Recruiting
Equity Medical
New York
New York
Recruiting
Velocity Clinical Research, Inc.
Raleigh
North Carolina
Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem
North Carolina
Recruiting
Neurology Clinic, PC
Cordova
Tennessee
Recruiting
Texas Neurology
Dallas
Texas
Recruiting
Rambam Medical Center
Haifa
Israel
Recruiting
Sourasky Medical Center
Tel Aviv
Israel
Recruiting
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen
Switzerland
Recruiting
More Janssen Research & Development, LLC trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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