Actively Recruiting
Study to Evaluate Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With Partial Response to Efgartigimod
Led by argenx · Updated on 2026-06-03
70
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and therapeutic relevance of empasiprubart as an add-on therapy to efgartigimod in people with AChR-Ab seropositive generalized myasthenia gravis who have a partial clinical response to efgartigimod. This study is part of the ADAPT Forward platform, aiming to identify the best treatments to reduce side effects and improve quality of life in myasthenia gravis. It is an exploratory Phase 2a study sponsored by argenx. The study includes a screening period followed by a run-in period (part A) where participants receive intravenous efgartigimod. Eligible participants then enter an add-on period (part B) receiving both efgartigimod and empasiprubart intravenously. Those not eligible for part B continue to a safety follow-up period (part C) receiving only efgartigimod. The total study duration for each participant is up to approximately 54 weeks. Participants will be monitored for adverse events and serious adverse events up to 21 weeks, focusing on safety and tolerability. Researchers will also assess changes in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores, Quantitative Myasthenia Gravis (QMG) scores, and other clinical measures over the study periods. Safety follow-up continues for participants not entering the add-on phase, ensuring ongoing evaluation throughout the study.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)
- Confirmed diagnosis of generalized myasthenia gravis classified as MGFA Class II, III, IVa, or IVb
- Documented immunization against Neisseria meningitidis and Streptococcus pneumoniae within 5 years prior to screening or willingness to receive immunization at least 14 days before first study drug administration
You will not qualify if you...
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Known complement deficiency
- Current treatment with complement inhibitors or received zilucoplan or eculizumab less than 2 months ago, or ravulizumab less than 6 months ago
- Proven lack of meaningful improvement with efgartigimod treatment (less than 2 points improvement in MG-ADL score)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive efgartigimod IV to evaluate initial response.
Visits during this period as per protocol schedule
Duration - Up to 18 weeks
Participants receive both efgartigimod IV and empasiprubart IV as add-on therapy.
Multiple visits during treatment cycles 1 and 2 as per protocol
Duration - Up to 21 weeks
Participants who are not eligible for the add-on therapy continue efgartigimod IV with safety monitoring.
Visits scheduled to monitor safety and adverse events
Trial Site Locations
Total: 13 locations
1
Profound Research LLC - Carlsbad
Carlsbad, California, United States, 92011
Actively Recruiting
2
Visionary Investigators Network
Miami, Florida, United States, 33176
Actively Recruiting
3
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
4
Dent Neurologic Institute - Amherst
Amherst, New York, United States, 14226
Actively Recruiting
5
Ohio State Martha Morehouse Outpatient Care
Columbus, Ohio, United States, 43221-3502
Actively Recruiting
6
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
7
National Neuromuscular Research Institute
Austin, Texas, United States, 78756
Actively Recruiting
8
University of Texas- San Antonio - Health Science Center - PPDS
San Antonio, Texas, United States, 78229
Actively Recruiting
9
UZ Leuven - PPDS
Leuven, Belgium, 3000
Actively Recruiting
10
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, Lombardy, Italy, 24127
Actively Recruiting
11
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Actively Recruiting
12
Centrum Medyczne Neurologia Slaska
Katowice, Silesian Voivodeship, Poland, 40-689
Actively Recruiting
13
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, Spain, 29010
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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