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
- Diseases
- Myasthenia gravis
- 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
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Klinikum Altenburger Land GmbH Coordinator of this site? Confirm its status | Altenburg | Germany | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Not yet recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Eginitio Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| General Hanamaki Hospital Coordinator of this site? Confirm its status | Hanamaki | Japan | Recruiting |
| National Hospital Organization Sendai Medical Center Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Krakowska Akademia Neurologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Neurologia Śląska Centrum Medyczne Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Centrum Medyczne Hope Clinic Sebastian Szklener Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Clinical Research Center Sp z o o Medic R Sp k Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Dent Neurologic Institute - Amherst Coordinator of this site? Confirm its status | Amherst | United States | Recruiting |
| National Neuromuscular Research Institute Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Neurology Center of Southern California Coordinator of this site? Confirm its status | Carlsbad | United States | Recruiting |
| Erlanger Health System Coordinator of this site? Confirm its status | Chattanooga | United States | Recruiting |
| Profound Research LLC at Las Vegas Neurology Center Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Visionary Investigators Network Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.