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Recruiting
NCT07284420
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
Conditions: AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 70
Sponsor: argenx
Location: Profound Research LLC - Carlsbad Carlsbad California
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 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
More information can be found here: https://clinicaltrials.argenx.com/adaptforward1
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 \
Source: ClinicalTrials.gov (NCT07284420). StuddyBuddy aggregates publicly available trial information.