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ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
Sponsor: argenx
Summary
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life. The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis. The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170
Official title: An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-12-19
Completion Date
2028-03-07
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Efgartigimod IV
Intravenous infusion of efgartigimod
Empasiprubart IV
Intravenous infusion of empasiprubart
Locations (5)
Profound Research LLC - Carlsbad
Carlsbad, California, United States
Visionary Investigators Network
Miami, Florida, United States
Dent Neurologic Institute - Amherst
Amherst, New York, United States
Erlanger Health System
Chattanooga, Tennessee, United States
National Neuromuscular Research Institute
Austin, Texas, United States