Recruiting

EPICNipocalimab vs Efgartigimod Comparison in Generalized Myasthenia Gravis Treatment

Study Aim

This study aims to compare the effectiveness of Nipocalimab and Efgartigimod in reducing total Immunoglobulin G (IgG) levels in individuals with Generalized Myasthenia Gravis, by observing the average mean percent change from baseline over Weeks 8, 10 and 12.

What is being tested

Nipocalimab

+ Efgartigimod

Drug

Who is being recruted

Autoimmune Diseases+10

+ Immune System Diseases

+ Myasthenia Gravis

From 18 to 74 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC

Study ContactStudy Contact

Last updated: March 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 5, 2026

Actual date on which the first participant was enrolled.

This clinical trial is focused on comparing the effectiveness of two medications, nipocalimab and efgartigimod, in treating individuals with generalized myasthenia gravis. Generalized myasthenia gravis is a disorder where the body's immune system attacks the connections between nerves and muscles, leading to muscle weakness. The study aims to determine which medication works better in managing this condition. Understanding the differences between these treatments could help improve the quality of life for those affected by this challenging disease. Participants in the trial will receive either nipocalimab or efgartigimod. During the study, some participants may switch from one medication to the other to evaluate the effectiveness of such a change. The study will measure how well each treatment alleviates the symptoms of muscle weakness associated with generalized myasthenia gravis. Safety and any side effects will also be closely monitored to ensure the treatments are not only effective but also safe for participants.

Official TitleEfficacy 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

NCT07217587

Principal SponsorJanssen Research & Development, LLC

Study ContactStudy Contact

Last updated: March 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

115 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 74 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesImmune System DiseasesMyasthenia GravisNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsNeuromuscular DiseasesParaneoplastic SyndromesNeurodegenerative DiseasesAutoimmune Diseases of the Nervous SystemParaneoplastic Syndromes, Nervous SystemNeuromuscular Junction Diseases

Criteria

5 inclusion criteria required to participate

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

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

Show More Criteria

5 exclusion criteria prevent from participating

Has received treatment for MG with an FcRn-targeting therapy

Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants in this group will receive Nipocalimab through an IV, starting with a loading dose on Day 1 and then once every 2 weeks until Week 12.

Group II

Experimental

Participants in this group have previously received efgartigimod and will now switch to receive nipocalimab, a different drug. This new drug will be given through an IV on the first day, followed by regular doses every two weeks until the 12th week.

Group III

Active Comparator

Participants in this group will receive a drug called Efgartigimod through an IV, once a week for 4 weeks. They may have the option to switch to another group between Week 4 and Week 12.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

University of Connecticut

Farmington, United StatesOpen University of Connecticut in Google Maps

Recruiting

SFM Clinical Research LLC

Boca Raton, United States

Recruiting

HSHS St. Elizabeth's Hospital

O'Fallon, United States

Recruiting

Henry Ford Hospital

Detroit, United States

Recruiting

7 Study Centers