Status:
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
Lead Sponsor:
argenx
Conditions:
AChR-Ab Seropositive Generalized Myasthenia Gravis
Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 myas...
Detailed Description
Once the master protocol and ISA1 screening periods are completed, eligible participants can enroll in the run-in period (part A) where they will receive efgartigimod IV. Eligible participants can the...
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)
Key Trial Info
Start Date :
December 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07284420
Start Date
December 19 2025
End Date
March 7 2028
Last Update
February 9 2026
Active Locations (5)
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1
Profound Research LLC - Carlsbad
Carlsbad, California, United States, 92011
2
Visionary Investigators Network
Miami, Florida, United States, 33176
3
Dent Neurologic Institute - Amherst
Amherst, New York, United States, 14226
4
Erlanger Health System
Chattanooga, Tennessee, United States, 37403