A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 30, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called nipocalimab for adults with generalized myasthenia gravis (gMG), a condition that causes muscle weakness. The main goal is to see if nipocalimab is effective and safe compared to a placebo, which is a harmless substance that looks like the treatment but has no active ingredients. The trial is currently looking for participants aged 65 to 74 years who have been diagnosed with gMG and have a certain level of muscle weakness. To qualify, participants need to have a specific score indicating their ability to perform daily activities and must be able to receive the treatment through an infusion.

If you or a family member are considering joining this study, you should know that participants will receive either nipocalimab or placebo and will be monitored for their health and response to the treatment. There are some important requirements to be eligible, such as not having certain other health conditions and not having had recent major health issues like a heart attack or stroke. It's also important for women who could become pregnant to have a negative pregnancy test before starting the study. This trial aims to provide more information on a potential new option for managing gMG, and participants play a crucial role in this research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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