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Clinical Trials in Japan / NCT07284420
Recruiting Phase 2

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

NCT07284420 · tracked via the Priya Life Science Japan tracker
Sponsor
argenx
Phase
Phase 2
Started
2025-12-19
Last updated
2026-09-24

Condition(s) studied

AChR-Ab Seropositive Generalized Myasthenia GravisMyasthenia GravisMGgMGGeneralized Myasthenia GravisGeneralized Myasthenia Gravis (gMG)

Investigational drug(s) / intervention(s)

Efgartigimod IV →Empasiprubart IV →

Efgartigimod IV: Intravenous infusion of efgartigimod

Empasiprubart IV: Intravenous infusion of empasiprubart

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Incidence of adverse events and serious adverse events in parts A and B — Up to 21 weeks

Trial sites (33)

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

More argenx trials in Japan

A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy Active, not recruiting
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis Recruiting
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease. Recruiting
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis Active, not recruiting
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP Recruiting

Other trials for the same condition

Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) Recruiting
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Active, not recruiting
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. Active, not recruiting
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis Recruiting
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284420 on ClinicalTrials.gov ↗ ← All trials in Japan