RecruitingPhase 2NCT07284420

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

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


Sponsor

argenx

Enrollment

70 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Efgartigimod IV and a biological treatment called Empasiprubart IV for people with achr-ab seropositive generalized myasthenia gravis, generalized myasthenia gravis, and other related conditions. The study is currently recruiting participants at 15 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEfgartigimod IV

Intravenous infusion of efgartigimod

BIOLOGICALEmpasiprubart IV

Intravenous infusion of empasiprubart


Locations(15)

Profound Research LLC - Carlsbad

Carlsbad, California, United States

Visionary Investigators Network

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Henry Ford Health Systems

Detroit, Michigan, United States

Dent Neurologic Institute - Amherst

Amherst, New York, United States

Duke Early Phase Clinical Research Unit - PPDS

Durham, North Carolina, United States

Ohio State Martha Morehouse Outpatient Care

Columbus, Ohio, United States

Erlanger Health System

Chattanooga, Tennessee, United States

National Neuromuscular Research Institute

Austin, Texas, United States

University of Texas- San Antonio - Health Science Center - PPDS

San Antonio, Texas, United States

UZ Leuven - PPDS

Leuven, Belgium

ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, Italy

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Neurologia Slaska

Katowice, Silesian Voivodeship, Poland

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Malaga, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07284420


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