Nipocalimab versus efgartigimod for generalized myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized head-to-head comparison enrolls adults with AChR-antibody positive generalized myasthenia gravis (MGFA class II–IV) and an MG-ADL score >= 5. Eligible participants are medically stable and may have a suboptimal response to current therapies or have discontinued certain immunosuppressants. Participants are assigned to receive either nipocalimab or efgartigimod and are followed for changes in muscle strength and daily functioning. The study is conducted at regional neurology centers in the United States.

Why it matters

Who can join: the full rules

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

Where it's running

• Neurology Center of North Orange County
  Fullerton, California, United States Recruiting
• The Neurology Group
  Pomona, California, United States Recruiting
• Research of the Rockies LLC
  Colorado Springs, Colorado, United States Recruiting
• University of Connecticut
  Farmington, Connecticut, United States Recruiting
• SFM Clinical Research LLC
  Boca Raton, Florida, United States Recruiting
• HSHS St. Elizabeth's Hospital
  O'Fallon, Illinois, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nipocalimab treatment for children with generalized myasthenia gravis

  This study is testing a new treatment called nipocalimab to see if it can help children with generalized myasthenia gravis who haven't responded well to other therapies.

  Recruiting at 15 sites Phase 2/3 Janssen Research & Development, LLC · Phoenix, Arizona and 18 other locations · NCT05265273

• Evaluating Nipocalimab for Adults with Generalized Myasthenia Gravis

  This study is testing a new drug called nipocalimab to see if it can help adults with generalized myasthenia gravis feel stronger and improve their daily activities compared to a placebo.

  Recruiting at 68 sites Phase 3 Janssen Research & Development, LLC · Paradise Valley, Arizona and 111 other locations · NCT04951622

• MG patient registry to track long-term experiences and treatment patterns

  This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.

  Recruiting Autoimmune Neurology Alliance · Framingham, Massachusetts · NCT07761026

• Ublituximab maintenance after efgartigimod response in myasthenia gravis

  This study tests whether giving ublituximab as maintenance after a positive response to efgartigimod helps adults with myasthenia gravis.

  Recruiting at 7 sites Phase 2 TG Therapeutics, Inc. · Colorado Springs, Colorado and 6 other locations · NCT07673744

• Nipocalimab in breast milk after a single IV dose in healthy lactating women

  This study tests how much nipocalimab shows up in breast milk after a single IV dose in healthy breastfeeding women.

  Recruiting Phase 1 Janssen Research & Development, LLC · Salt Lake City, Utah · NCT07669077

• Pregnant Women with Neuroimmune Diseases: A long-term follow-up study

  This study follows women with neuroimmune diseases and healthy controls through pregnancy and up to ten years to see how pregnancy affects disease activity and outcomes for both mother and baby.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT07653984

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.