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RECRUITINGPhase 2INTERVENTIONAL

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

An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

BIOLOGICAL

Efgartigimod IV

Intravenous infusion of efgartigimod

BIOLOGICAL

Empasiprubart IV

Intravenous infusion of empasiprubart

Locations (5)

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