Nipocalimab treatment for children with 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 study evaluates the effects of nipocalimab on serum immunoglobulin G levels in pediatric patients aged 2 to less than 18 years with generalized myasthenia gravis. It aims to assess the safety, tolerability, and pharmacokinetics of nipocalimab in children who have not responded adequately to standard treatments. The study will involve participants from various locations globally, with specific age criteria for U.S. sites. Participants will receive the treatment through infusion while undergoing regular monitoring.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Age: For US sites only: 8 to \< 18 years
* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class IIa/b, IIIa/b, or IVa/b at screening
* Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening
* A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study
* Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
* Participants should have a body weight and body mass index between 5th and 95th percentile for age and sex. Obese participants greater than 95th percentile and underweight participants below 5th percentile may participate following medical clearance
* A female of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention

Key Exclusion Criteria:

* Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/ autoimmune hepatitis/ cirrhosis/ and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular (including congenital heart diseases), psychiatric, neurological musculoskeletal disorder, any other medical disorder(s) (example, diabetes mellitus), risk factors for thrombosis events (example, a history of venous thromboembolism \[VTE\] or antiphospholipid syndrome, or a personal or family history of heritable coagulation disorder such as factor V leiden, protein S or protein C deficiency, atrial fibrillation/flutter, major orthopedic surgery or significant trauma that may increase the risk of VTE, is expected to be immobilized for prolonged periods of time), or has clinically significant abnormalities in screening laboratory, that might interfere with participant's full participation in the study, and/ or might jeopardize the safety of the participant or the validity of the study results
* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
* Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)
* Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening

Where it's running

• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Lucile Packard Children's Hospital Stanford
  Palo Alto, California, United States Recruiting
• UCSF Benioff Children's Hospital
  San Francisco, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• University of South Florida Morsani Center for Advanced Healthcare
  Tampa, Florida, United States Recruiting
• C.S. Mott Children's Hospital
  Ann Arbor, Michigan, 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 versus efgartigimod for generalized myasthenia gravis

  This trial will test whether nipocalimab or efgartigimod works better to reduce muscle weakness in adults with AChR-positive generalized myasthenia gravis who have meaningful symptoms despite stable therapy.

  Recruiting at 30 sites Phase 3 Janssen Research & Development, LLC · Fullerton, California and 30 other locations · NCT07217587

• 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.

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• 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.