Comparison of the Efficacy of Nipocalimab and Efgartigimod in Patients with Generalized Myasthenia Gravis (EPIC)
Summary description of the study
Myasthenia gravis (MG) is a disease in which the body's immune system produces antibodies that attack tissues in the body. These antibodies block signals from the nerves to the muscle cells, causing muscle weakness and fatigue. Nipocalimab and Efgartigimod work in different ways and are administered according to different regimens for the treatment of gMG. However, there is no information on which treatment works better and how they can be applied more effectively. Additionally, more data is needed for patients who need to switch from one treatment to another to understand whether the switch is safe and effective. Nipocalimab (JNJ-80202135) is a monoclonal antibody*, and Efgartigimod is part of a monoclonal antibody. Both treatments inhibit the binding of the neonatal Fc receptor** (FcRn) to IgG antibodies. This leads to a reduction in the concentrations of circulating IgG, including the IgG that causes generalized MG (gMG, a type of MG that causes generalized muscle weakness). * A type of protein that can recognize and bind to a specific target. ** A protein that prolongs the half-life of IgG in peripheral blood by blocking the normal degradation of IgG. In this trial, researchers want to assess how well Nipocalimab works compared to Efgartigimod in patients starting FcRn treatment for gMG. The overall trial includes the following phases: Screening, Open-Label Head-to-Head (Arms 1 and 2), Open-Label Treatment Switch (Arm 3), and Follow-Up to assess safety. Safety assessments include evaluating adverse events, the use of associated medications, physical examinations, vital signs, laboratory tests, and pregnancy tests. The approximate duration of the trial is up to 24 weeks for Arms 1 and 2 and up to 36 weeks for Arm 3.
(BASEC)
Intervention under investigation
Experimental Arm: Treatment Arm 1: Nipocalimab
Patients receive Nipocalimab intravenously (i.v.) in a loading dose on Day 1; thereafter, a maintenance dose is administered once every 2 weeks (q2w) until Week 12.
Active Comparator: Treatment Arm 2: Efgartigimod
Patients receive Efgartigimod i.v. once weekly for four weeks starting on Day 1. Eligible patients have the option to switch to Treatment Arm 3 between Week 4 and Week 12.
Experimental Arm: Treatment Arm 3: Treatment Switch (Nipocalimab)
Patients previously treated with Efgartigimod who are directly enrolled in this treatment arm, and eligible patients switching from Treatment Arm 2, receive Nipocalimab i.v. in a loading dose on Day 1; thereafter, a maintenance dose is administered every two weeks (q2w) until Week 12 of the switch phase.
(BASEC)
Disease under investigation
Myasthenia Gravis
(BASEC)
For all treatment arms: a. Medically stable according to physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) at screening b. Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) Class II a/b, III a/b, or IV a/b according to the clinical classification of the Myasthenia Gravis Foundation of America (MGFA) at screening and tested positive for acetylcholine receptor antibodies (AChR antibodies) c. Score of the Myasthenia Gravis Activities of Daily Living scale (MG-ADL) of greater than or equal to (>=) 5, with less than (<) 50% of symptoms associated with ocular MG-ADL subscores, at screening and baseline visits (Day 1) of the trial Specific criteria for Treatment Arms 1 and 2 only: - According to the investigator's statement, there is suboptimal response to the current stable gMG therapy or corticosteroids and/or immunosuppressants/immunomodulators, including Eculizumab or other novel approved immunotherapeutics, were discontinued no later than 4 weeks before the start of the trial due to intolerance or lack of efficacy Specific criterion for Treatment Arm 3: - Treatment with Efgartigimod i.v. or subcutaneously (s.c.) for at least one cycle, and the last cycle corresponds to local approval. (BASEC)
Exclusion criteria
Exclusion criteria: • Confirmed or suspected clinical immunodeficiency syndrome not related to the treatment of gMG, or family history of congenital or hereditary immunodeficiency, unless it has been confirmed that this is not present in the patient • Thymectomy within one year prior to the start of the trial or thymectomy planned during the trial • Current malignant disease or history of malignant disease within the 3 years prior to the start of the trial Specific criteria for Treatment Arms 1 and 2 only: - Has received MG treatment with a therapy directed against FcRn Specific criteria for Treatment Arm 3 only: - Currently receiving monoclonal IgG antibody therapeutics or Fc-conjugated therapeutics, including factor or enzyme substitution, except for Efgartigimod. (BASEC)
Trial sites
St. Gallen
(BASEC)
Sponsor
Janssen-Cilag AG
(BASEC)
Contact
Contact Person Switzerland
Study Contact
+1 844 434 4210
Participate-In-This-Study1@clutterits.jnj.comJanssen-Cilag GmbH
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
01.04.2026
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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 (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available