Empasiprubart tested in adults with AChR antibody-positive generalized myasthenia gravis
Tests empasiprubart against placebo in adults with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Athens and Thessaloniki, GreeceSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with generalized myasthenia gravis who have antibodies against the acetylcholine receptor (AChR-Ab). It tests the safety and effect of empasiprubart given through a vein.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Confirmed generalized myasthenia gravis, MGFA Class II, III, IVa, or IVb.
- Earlier treatment
- Must have documented vaccination against Neisseria meningitidis and Streptococcus pneumoniae within 5 years before screening, or finish it at least 14 days before the first dose. Cannot have had an FcRn antagonist, including efgartigimod, within 4 weeks before baseline. Cannot have had empasiprubart before.
- Biomarker or test result
- Positive test for anti-acetylcholine receptor antibodies (AChR-Ab).
Main reasons for not taking part
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Currently taking complement inhibitors such as eculizumab, zilucoplan or ravulizumab
- FcRn antagonist, including efgartigimod, within 4 weeks before baseline
- Earlier treatment with empasiprubart
Read by machine on 9 November 2026.
Where in Greece
- Eginitio HospitalAthens, GreeceTaking people
- University General Hospital of Thessaloniki - AHEPAThessaloniki, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- argenx
- Trial code
- NCT07673627EU 2025-522939-33-00
- Record updated
- 4 November 2026
- Original 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.Read full original descriptionShow less
ISA2 to Master Protocol ARGX-999-2-MG-2000 - an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
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
Inclusion: 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: 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; Clinical diagnosis of systemic lupus erythematosus (SLE).