An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Janssen Research & Development, LLC
Summary
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
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 supplem…
Interventions
- DrugNipocalimab
Nipocalimab will be administered as an IV infusion.
Locations (19)
- Phoenix Children's HospitalPhoenix, Arizona
- Childrens Hospital Los AngelesLos Angeles, California
- Lucile Packard Children's Hospital StanfordPalo Alto, California
- UCSF Benioff Children's HospitalSan Francisco, California
- Children's Hospital ColoradoAurora, Colorado
- University of South Florida Morsani Center for Advanced HealthcareTampa, Florida