NCT07284420RecruitingPhase 2
MP: ADAPT Forward - Master protocol of a platform study to evaluate the safety and efficacy of multiple regimens in participants with Myasthenia Gravis. ISA1: 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.
Master Protocol Full Title: A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 1 Full Title: An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of 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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Oct 2026
Brief summary (registry, in English)
MP - To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes. ISA 1 - To determine the safety and tolerability of empasiprubart as add-on therapy to efgartigimod.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 15 Oct 2025
- Start date
- 13 Mar 2026
- Lead sponsor
- Argenx
- Diseases
- Myasthenia gravis
- EU CT number
- 2025-522492-28-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 52
- 20 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ISA 1 Main 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).
Other illness
- MP Main exclusion criteria: - Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk. - Is MGFA (Myasthenia Gravis Foundation of America) Class V
Who the study is looking for
- MP Main inclusion criteria: o Is at least 18 years of age and the local legal age of consent for clinical studies o Has been diagnosed with MG consistent with MG's clinical features and with symptom severity appropriate for currently enrolling ISAs, per the investigator’s clinical judgment o If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening
- ISA 1 Main 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
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 | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | 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 |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | 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 |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.