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Clinical Trials in the Netherlands / NCT07673627
Recruiting Phase 2

ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

NCT07673627 · tracked via the Priya Life Science Netherlands tracker
Sponsor
argenx
Phase
Phase 2
Started
2026-07-10
Last updated
2026-11-04

Condition(s) studied

AChR-Ab Seropositive Generalized Myasthenia GravisMyasthenia Gravis (MG)MG - Myasthenia GravisgMG

Investigational drug(s) / intervention(s)

Empasiprubart IV →Placebo IVEfgartigimod PH20 SC PFS

Empasiprubart IV: Intravenous infusions of empasiprubart

Placebo IV: Intravenous infusions of placebo

Efgartigimod PH20 SC PFS: Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)

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 ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG).

The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

More information can be found here: https://clinicaltrials.argenx.com/adaptforward2

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 before ISA screening or will complete immunization at least 14 days before the first IMP administration. Exclusion Criteria: * Clinical diagnosis of systemic lupus erythematosus (SLE). * Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab \>2 months or ravulizumab \>6 months before baseline are allowed to participate. * Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline. * Had prior empasiprubart exposure.

Primary outcome measure(s)

  • Incidence of adverse events and serious adverse events in the DBTP — Up to 12 weeks

Trial sites (14)

FacilityCityRegionStatus
Neurology Center of Southern California Carlsbad California Recruiting
Visionary Investigators Network Miami Florida Recruiting
Profound Research LLC at Las Vegas Neurology Center Las Vegas Nevada Recruiting
Dent Neurologic Institute - Amherst Amherst New York Recruiting
Erlanger Health System Chattanooga Tennessee Recruiting
National Neuromuscular Research Institute Austin Texas Recruiting
UZ Leuven Leuven Belgium Recruiting
AHEPA University General Hospital of Thessaloniki Thessaloniki Thessaloniki Recruiting
Eginitio Hospital Athens Greece Recruiting
General Hanamaki Hospital Hanamaki Japan Recruiting
National Hospital Organization Sendai Medical Center Sendai Japan Recruiting
Leids Universitair Medisch Centrum Leiden Netherlands 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 the Netherlands

A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy Active, not recruiting
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis Enrolling by invitation
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis Recruiting
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis Active, not recruiting

Other trials for the same condition

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis Enrolling by invitation
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis Active, not 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 NCT07673627 on ClinicalTrials.gov ↗ ← All trials in the Netherlands