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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: argenx • ClinicalTrials.gov ID: NCT07284420

Registry updated: 2026-09-24
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Description

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

Interventions

  • Efgartigimod IV (Biological)
    Intravenous infusion of efgartigimod
  • Empasiprubart IV (Biological)
    Intravenous infusion of empasiprubart

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)

Conditions

AChR-Ab Seropositive Generalized Myasthenia Gravis Myasthenia Gravis MG gMG Generalized Myasthenia Gravis Generalized Myasthenia Gravis (gMG)

Locations

  • Profound Research LLC - Carlsbad — Carlsbad, California, United States
  • Visionary Investigators Network — Miami, Florida, United States
  • University of South Florida — Tampa, Florida, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • Henry Ford Health Systems — Detroit, Michigan, United States
  • Profound Research LLC at Las Vegas Neurology Center — Las Vegas, Nevada, United States
  • Dent Neurologic Institute - Amherst — Amherst, New York, United States
  • University of North Caroline at Chapel Hill-170 Manning Dr — Chapel Hill, North Carolina, United States
  • Duke Early Phase Clinical Research Unit - PPDS — Durham, North Carolina, United States
  • University of Cincinnati Medical Center - Goodman St — Cincinnati, Ohio, United States
  • Ohio State Martha Morehouse Outpatient Care — Columbus, Ohio, United States
  • Erlanger Health System — Chattanooga, Tennessee, United States
  • National Neuromuscular Research Institute — Austin, Texas, United States
  • University of Texas- San Antonio - Health Science Center - PPDS — San Antonio, Texas, United States
  • UZ Leuven - PPDS — Leuven, Belgium
  • Charité - Universitätsmedizin Berlin — Berlin, Germany
  • Universitätsmedizin Göttingen — Göttingen, Germany
  • Universitätsklinikum Würzburg — Würzburg, Germany
  • Eginitio Hospital — Athens, Greece
  • AHEPA University General Hospital of Thessaloniki — Thessaloniki, Greece
  • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII — Bergamo, Lombardy, Italy
  • Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy
  • AORN Antonio Cardarelli — Naples, Italy
  • University of Tsukuba Hospital — Tsukuba, Ibaraki, Japan
  • St. Marianna University Hospital — Kawasaki-shi, Kanagawa, Japan
  • National Hospital Organization Sendai Medical Center — Sendai, Miyagi, Japan
  • General Hanamaki Hospital - Kajomachi — Hanamaki, Japan
  • IUHW Narita Hospital — Narita, Japan
  • MICS Centrum Medyczne Bydgoszcz — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Centrum Medyczne Neurologia Slaska — Katowice, Silesian Voivodeship, Poland
  • Warszawski Uniwersytet Medyczny — Warsaw, Poland
  • Hospital Regional Universitario de Malaga - Hospital General — Málaga, Malaga, Spain
  • Hospital de La Santa Creu i Sant Pau — Barcelona, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record