What this study is
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).
What's being tested
- Nipocalimab
Intervention · DRUG
Nipocalimab will be administered intravenously.
- Efgartigimod
Intervention · DRUG
Efgartigimod will be administered intravenously.
Study details
- Official title
- Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab
- Sponsor
- Janssen Research & Development, LLC
- Conditions
- Myasthenia Gravis
- Enrolling
- 115 people
- Starts
- 2026-01-05
- Est. completion
- 2029-01-29
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 74 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
- Treatment with efgartigimod IV or subcutaneous (SC) for >=1 cycle, and the final cycle is consistent with product information
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (31)
30 openNeurology Center of North Orange County
Fullerton, California, United States
RecruitingThe Neurology Group
Pomona, California, United States
RecruitingResearch of the Rockies LLC
Colorado Springs, Colorado, United States
RecruitingUniversity of Connecticut
Farmington, Connecticut, United States
RecruitingSFM Clinical Research LLC
Boca Raton, Florida, United States
RecruitingHSHS St. Elizabeth's Hospital
O'Fallon, Illinois, United States
RecruitingJosephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States
RecruitingTulane Center for Clinical Research
New Orleans, Louisiana, United States
RecruitingNeurology Center Of New England PC
Foxborough, Massachusetts, United States
RecruitingHenry Ford Hospital
Detroit, Michigan, United States
RecruitingMichigan State University
East Lansing, Michigan, United States
RecruitingEquity Medical
New York, New York, United States
RecruitingVelocity Clinical Research, Inc.
Raleigh, North Carolina, United States
RecruitingAtrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
RecruitingNeurology Clinic, PC
Cordova, Tennessee, United States
RecruitingAustin Neuromuscular Center
Austin, Texas, United States
RecruitingTexas Neurology
Dallas, Texas, United States
RecruitingThe University of Texas Health Science Center at Houston
Houston, Texas, United States
RecruitingEvergreenHealth Neurology
Kirkland, Washington, United States
RecruitingAdvanced Neurology of Colorado
Fort Collins, Colorado, United States
Completed
11 sites outside the US
Klinikum Altenburger Land GmbH
Altenburg, Germany
RecruitingKatholisches Klinikum Bochum gGmbH
Bochum, Germany
RecruitingUniversitatsklinikum Freiburg
Freiburg im Breisgau, Germany
RecruitingRambam Medical Center
Haifa, Israel
RecruitingSourasky Medical Center
Tel Aviv, Israel
RecruitingHosp. Clinic de Barcelona
Barcelona, Spain
RecruitingHosp. Univ. Ramon Y Cajal
Madrid, Spain
RecruitingHosp. Univ. Infanta Sofia
Madrid, Spain
RecruitingHosp. Virgen Macarena
Seville, Spain
RecruitingHosp. Clinico Univ. de Valencia
Valencia, Spain
RecruitingHOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, Switzerland
Recruiting
Study team
Sponsor
Janssen Research & Development, LLC
Study ID 80202135MYG3002
Study director
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.