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NCT07673627RecruitingPhase 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

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
23 Jun 2026
Start date
10 Jul 2026
Primary completion date
Oct 2027
Lead sponsor
argenx
NCT number
NCT07673627
EU CT number
2025-522939-33-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 10 Jul 2026 to the primary completion date, Oct 2027
  • 30 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • Clinical diagnosis of systemic lupus erythematosus (SLE).

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumRecruiting
Klinikum Altenburger Land GmbH
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AltenburgGermanyNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyNot yet recruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyNot yet recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
Eginitio Hospital
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AthensGreeceRecruiting
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyRecruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
General Hanamaki Hospital
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HanamakiJapanRecruiting
National Hospital Organization Sendai Medical Center
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SendaiJapanRecruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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BydgoszczPolandRecruiting
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandRecruiting
Neurologia Śląska Centrum Medyczne
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KatowicePolandRecruiting
Centrum Medyczne Hope Clinic Sebastian Szklener
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LublinPolandRecruiting
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandRecruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandRecruiting
Dent Neurologic Institute - Amherst
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AmherstUnited StatesRecruiting
National Neuromuscular Research Institute
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AustinUnited StatesRecruiting
Neurology Center of Southern California
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CarlsbadUnited StatesRecruiting
Erlanger Health System
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ChattanoogaUnited StatesRecruiting
Profound Research LLC at Las Vegas Neurology Center
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Las VegasUnited StatesRecruiting
Visionary Investigators Network
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MiamiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.