Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorJanssen Research & Development, LLC

About this trial

The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).

Eligibility criteria

Qualifiers

Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening

Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies

Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 5 with less than (<) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits

Disqualifiers

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

Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study

Currently has a malignancy or has a history of malignancy within 3 years before baseline

Trial design

Treatments tested in this trial

  • Nipocalimab
  • Efgartigimod

Treatment groups

115 Participants
are divided into 3 treatment groups