ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
NCT ID: NCT07294170
Last Updated: 2026-01-12
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
70 participants
OBSERVATIONAL
2025-12-19
2028-03-07
Brief Summary
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Detailed Description
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The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration.
Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study:
* NCT07284420 - ADAPT Forward 1 - 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 (https://www.clinicaltrials.gov/study/NCT07284420)
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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ISA1 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
Efgartigimod IV
Intravenous infusion of efgartigimod
Empasiprubart IV
Intravenous infusion of empasiprubart
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 been diagnosed with MG with consistent clinical features per the investigator's clinical judgment
* If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening
Exclusion Criteria
* Is MGFA (Myasthenia Gravis Foundation of America) Class V
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
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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ARGX-999-2-MG-2000
Identifier Type: -
Identifier Source: org_study_id
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