Evaluating Ublituximab Maintenance After Efgartigimod Induction in Adults with Myasthenia Gravis

What this Trial Is About

Researchers are evaluating the use of ublituximab as a maintenance treatment in adults with Myasthenia Gravis MG who have responded to induction treatment with efgartigimod. This Phase 2 study aims to assess the efficacy and safety of ublituximab in maintaining disease control compared to placebo for responders, and to monitor non-responders receiving ublituximab. The study is sponsored by TG Therapeutics, Inc. and focuses on preventing clinical worsening in MG. Participants who responded to efgartigimod induction will be randomly assigned to receive either ublituximab or a placebo through intravenous IV infusion. Those who did not respond will receive ublituximab IV infusions openly. This double-blind, randomized trial includes a randomized controlled period followed by an open-label period where all participants may receive ublituximab. Treatments are given by IV infusion according to the study protocol. During the study, participants will be monitored for clinical worsening events up to 24 weeks and followed for safety and other outcomes up to 72 weeks. Assessments include measuring adverse events, blood levels of ublituximab, B-cell counts, and changes in MG-related daily living activities. Participants will receive regular evaluations and intravenous treatments as scheduled, with ongoing monitoring to assess treatment effects and safety throughout the study duration.

A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)