Last updated 27 days ago

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

196 patients around the world
Available in Mexico, United States, Colombia, Spain
Janssen Research & Development, LLC
1Research sites
196Patients around the world

This study is for people with

Myasthenia gravis
Myasthenia gravis in adults

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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 II a/b, III a/b, or IVa/b at screening
Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 6 at screening and baseline
Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
A woman 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
A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
Has 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
Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening

Sites

Hospital Civil de Guadalajara Fray Antonio Alcalde
Recruiting
Guadalajara, Jalisco, Mexico, 44280
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