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
2 other identifiers
interventional
70
8 countries
24
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2025
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedStudy Start
First participant enrolled
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 7, 2028
July 30, 2026
July 1, 2026
2.2 years
December 8, 2025
July 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events and serious adverse events in parts A and B
Up to 21 weeks
Secondary Outcomes (7)
MG-ADL total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG ADL total score change from baseline at week 4 in part A
Up to 18 weeks
Proportion of participants reaching MSE at any point in part B cycles 1 and 2, and part B cycles 1 or 2
Up to 21 weeks
MG-ADL total score changes from baseline over time in part B compared with part A
Up to 21 weeks
QMG total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A
Up to 18 weeks
QMG total score changes from baseline over time in part B compared with part A
Up to 21 weeks
- +2 more secondary outcomes
Study Arms (2)
Efgartigimod IV + Empasiprubart IV
EXPERIMENTALParticipants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B
Efgartigimod IV (part A + C)
EXPERIMENTALParticipants not eligible for part B, receiving efgartigimod IV in part A and C
Interventions
Intravenous infusion of efgartigimod
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- argenxlead
Study Sites (24)
Profound Research LLC - Carlsbad
Carlsbad, California, 92011, United States
Visionary Investigators Network
Miami, Florida, 33176, United States
University of South Florida
Tampa, Florida, 33620, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621, United States
Henry Ford Health Systems
Detroit, Michigan, 48202-2608, United States
Dent Neurologic Institute - Amherst
Amherst, New York, 14226, United States
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, 27710-0001, United States
Ohio State Martha Morehouse Outpatient Care
Columbus, Ohio, 43221-3502, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
National Neuromuscular Research Institute
Austin, Texas, 78756, United States
University of Texas- San Antonio - Health Science Center - PPDS
San Antonio, Texas, 78229, United States
UZ Leuven - PPDS
Leuven, 3000, Belgium
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Eginitio Hospital
Athens, 115 28, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36, Greece
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, Lombardy, 24127, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
AORN Antonio Cardarelli
Naples, 80131, Italy
IUHW Narita Hospital
Narita, 286-8520, Japan
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Neurologia Slaska
Katowice, Silesian Voivodeship, 40-689, Poland
Warszawski Uniwersytet Medyczny
Warsaw, 00-665, Poland
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, 29010, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2025
First Posted
December 16, 2025
Study Start
December 19, 2025
Primary Completion (Estimated)
March 7, 2028
Study Completion (Estimated)
March 7, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share