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
- AChR-Ab Seropositive Generalized Myasthenia Gravis
- Myasthenia Gravis
- MG
- gMG
- Generalized Myasthenia Gravis
- Generalized Myasthenia Gravis (gMG)
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- argenx
- Enrolment target
- 70
- Started
- 19 December 2025
- Main results due
- 7 March 2028
- Study sites
- 33
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Clinical diagnosis of systemic lupus erythematosus (SLE) * Any known complement deficiency * Current administration of a complement inhibitor or received zilucoplan or eculizumab \<2 months or ravulizumab \<6 months before the first study drug administration * Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(33)
Profound Research LLC - Carlsbad
Carlsbad, California, United States
Recruiting
Visionary Investigators Network
Miami, Florida, United States
Recruiting
University of South Florida
Tampa, Florida, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Henry Ford Health Systems
Detroit, Michigan, United States
Recruiting
Profound Research LLC at Las Vegas Neurology Center
Las Vegas, Nevada, United States
Recruiting
Dent Neurologic Institute - Amherst
Amherst, New York, United States
Recruiting
University of North Caroline at Chapel Hill-170 Manning Dr
Chapel Hill, North Carolina, United States
Recruiting
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, United States
Recruiting
University of Cincinnati Medical Center - Goodman St
Cincinnati, Ohio, United States
Recruiting
Ohio State Martha Morehouse Outpatient Care
Columbus, Ohio, United States
Recruiting
Erlanger Health System
Chattanooga, Tennessee, United States
Recruiting
National Neuromuscular Research Institute
Austin, Texas, United States
Recruiting
University of Texas- San Antonio - Health Science Center - PPDS
San Antonio, Texas, United States
Recruiting
UZ Leuven - PPDS
Leuven, Belgium
Recruiting
Charité - Universitätsmedizin Berlin
Berlin, Germany
Recruiting
Universitätsmedizin Göttingen
Göttingen, Germany
Recruiting
Universitätsklinikum Würzburg
Würzburg, Germany
Recruiting
Eginitio Hospital
Athens, Greece
Recruiting
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Greece
Recruiting
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Recruiting
AORN Antonio Cardarelli
Naples, Italy
Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Recruiting
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
Recruiting
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Recruiting
General Hanamaki Hospital - Kajomachi
Hanamaki, Japan
Recruiting
IUHW Narita Hospital
Narita, Japan
Recruiting
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Recruiting
Centrum Medyczne Neurologia Slaska
Katowice, Silesian Voivodeship, Poland
Recruiting
Warszawski Uniwersytet Medyczny
Warsaw, Poland
Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, Spain
Recruiting
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain
Recruiting
Showing 33 of 33 sites. 33 of the 33 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07284420. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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