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
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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 More information can be found here: https://clinicaltrials.argenx.com/adaptforward1
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)
• Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb
• Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration
Locations
United States
California
Profound Research LLC - Carlsbad
RECRUITING
Carlsbad
Florida
Visionary Investigators Network
RECRUITING
Miami
University of South Florida
RECRUITING
Tampa
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Henry Ford Health Systems
RECRUITING
Detroit
North Carolina
Duke Early Phase Clinical Research Unit - PPDS
RECRUITING
Durham
New York
Dent Neurologic Institute - Amherst
RECRUITING
Amherst
Ohio
Ohio State Martha Morehouse Outpatient Care
RECRUITING
Columbus
Tennessee
Erlanger Health System
RECRUITING
Chattanooga
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
University of Texas- San Antonio - Health Science Center - PPDS
RECRUITING
San Antonio
Other Locations
Belgium
UZ Leuven - PPDS
RECRUITING
Leuven
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsmedizin Göttingen
RECRUITING
Göttingen
Universitätsklinikum Würzburg
RECRUITING
Würzburg
Greece
Eginitio Hospital
RECRUITING
Athens
AHEPA University General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Italy
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
RECRUITING
Bergamo
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
AORN Antonio Cardarelli
RECRUITING
Naples
Japan
General Hanamaki Hospital - Kajomachi
RECRUITING
Hanamaki
IUHW Narita Hospital
RECRUITING
Narita
Poland
MICS Centrum Medyczne Bydgoszcz
RECRUITING
Bydgoszcz
Centrum Medyczne Neurologia Slaska
RECRUITING
Katowice
Warszawski Uniwersytet Medyczny
RECRUITING
Warsaw
Spain
Hospital de La Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Regional Universitario de Malaga - Hospital General
RECRUITING
Málaga
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date:2025-12-19
Estimated Completion Date:2028-03-07
Participants
Target number of participants:70
Treatments
Experimental: Efgartigimod IV + Empasiprubart IV
Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B
Experimental: Efgartigimod IV (part A + C)
Participants not eligible for part B, receiving efgartigimod IV in part A and C