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Clinical Trial Details

Title
Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis
Study Description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Nipocalimab compared to placebo in participants aged 18-Year or older with Generalized Myasthenia Gravis (gMG) who are inadequately controlled with the standard of care therapy.

Participants who have completed the double-blind placebo-controlled phase of the study have an option to receive open-label treatment of Nipocalimab to evaluate the long-term safety and efficacy of Nipocalimab.

The screening period is to determine if you can participate in the study. If you are able to participate you will then be enrolled in the Double-Blind Placebo-Controlled Treatment Period which will last for about 24 weeks. Participants in this period of the study will receive either Nipocalimab or a placebo. At the end of the Double-Blind treatment period, your study doctor will determine if you are eligible to enroll in the Open-Label Extension (OLE) period in which you would be able to receive Nipocalimab infusions for approximately 2-5 years. At the end of your participation in the study, you will be asked to complete a Follow-Up Visit. This will occur 8 weeks after your final infusion.

During the Double-Blind Placebo-Controlled period you will either receive Nipocalimab or a placebo (no drug). You will randomly, or by chance, be put into a treatment group.

There are 2 treatment groups in this study. You will have a 1:1 chance (or 50% chance) of being put into either group:
• Placebo infusion (no drug)
• Nipocalimab infusion of 15 mg/kg (following a loading dose of 30 mg/kg)

During the Open-Label Extension period, you will receive 15 mg/kg of Nipocalimab every 2 weeks. After 6 months, the dosing regimen could change to 30 mg/kg every 4 weeks, but your study doctor will discuss this with you further.

The study drug infusion will be administered to you at the study clinic by the doctor/staff. The study drug is put into a vein in your arm through a small tube attached to a needle. This will be done once every two weeks. You are allowed to remain on your current MG treatment throughout the study, regardless of what treatment group you are assigned.

You may receive a stipend per study visit day to help with your incidental expenses related to attending study visits (meals/parking/gas).

Study staff will be available via phone or email to answer any questions you may have if you are interested in participating in the trial or would like to learn more about the study.

Open Enrollment
Contact Name: Yasmeen Shabbir
Contact Phone: (904) 244-9856
Contact Email: yasmeen.shabbir@jax.ufl.edu
Investigators

Principal Investigator
Michael T. Pulley, M.D., Ph.D.
Neurology

Sub Investigator
Shannon M. LaBoy, M.D.
Neurology