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
NCT ID: NCT07284420
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2025-12-19
2028-03-07
Brief Summary
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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
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Detailed Description
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Participants who are not eligible for part B will continue directly to the safety follow-up period (part C) where they will receive efgartigimod IV only.
The study duration for each participant is approximately up to 54 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Efgartigimod IV + Empasiprubart IV
Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B
Efgartigimod IV
Intravenous infusion of efgartigimod
Empasiprubart IV
Intravenous infusion of empasiprubart
Efgartigimod IV (part A + C)
Participants not eligible for part B, receiving efgartigimod IV in part A and C
Efgartigimod IV
Intravenous infusion of efgartigimod
Interventions
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Efgartigimod IV
Intravenous infusion of efgartigimod
Empasiprubart IV
Intravenous infusion of empasiprubart
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Profound Research LLC - Carlsbad
Carlsbad, California, United States
Visionary Investigators Network
Miami, Florida, United States
Dent Neurologic Institute - Amherst
Amherst, New York, United States
Erlanger Health System
Chattanooga, Tennessee, United States
National Neuromuscular Research Institute
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-522492-28-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-999-2-MG-20001
Identifier Type: -
Identifier Source: org_study_id
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