Actively Recruiting
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
Led by argenx · Updated on 2026-04-23
70
Participants Needed
9
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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)
- Diagnosed with generalized myasthenia gravis (gMG) classified as MGFA Class II, III, IVa, or IVb
- Documented immunization against Neisseria meningitidis and Streptococcus pneumoniae within 5 years before 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 a complement inhibitor or received zilucoplan or eculizumab within 2 months or ravulizumab within 6 months before first study drug administration
- Proven refractory to efgartigimod, defined as no meaningful improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) score (improvement of 2 points)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 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
Dent Neurologic Institute - Amherst
Amherst, New York, United States, 14226
Actively Recruiting
4
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
5
National Neuromuscular Research Institute
Austin, Texas, United States, 78756
Actively Recruiting
6
UZ Leuven - PPDS
Leuven, Belgium, 3000
Actively Recruiting
7
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Actively Recruiting
8
Centrum Medyczne Neurologia Slaska
Katowice, Silesian Voivodeship, Poland, 40-689
Actively Recruiting
9
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, Spain, 29010
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
CONTACT
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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