A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
ConditionMyasthenia Gravis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nipocalimab
- Placebo
- Nipocalimab SC-LIV
Treatment groups
199 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov