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

StatusRecruiting

PhasePhase 2

Sponsorargenx

Started2025-12-19

View on ClinicalTrials.gov ↗

Amendment history

2026-08-20

Study Status, Contacts/Locations v9

Trial sites expanded: 27 → 32 locations

Trial sites expanded: 24 → 27 locations

2026-07-28

Study Status, Study Description, Contacts/Locations, References v8

Trial sites expanded: 15 → 24 locations

2026-06-11

Study Status, Contacts/Locations v7

Study sites13→15

2026-06-02

Study Status, Contacts/Locations v6

Trial sites expanded: 10 → 13 locations

Study sitesdetails revised at 4 of 13 sites

2026-05-29

Study Status, Contacts/Locations v5

Study sites10→13

2026-05-28

Study Status, Contacts/Locations v4

Study sites9→10

2026-04-22

Study Status, Contacts/Locations v3

Trial sites expanded: 5 → 9 locations

2026-02-06

Study Status, Contacts/Locations v2

Study sites3→5

2026-01-09

Not Yet Recruiting→Recruiting Study Status, Study Description, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-12→confirmed 2025-12-19

Study sites0→3

2025-12-08

Original filing

Argenx

56 trials monitored

See 2 trials at risk

Myasthenia Gravis

187 trials monitored

See 7 trials at risk

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 ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis. The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170 More information can be found here: https://clinicaltrials.argenx.com/adaptforward1

Trial Details

NCT Number	NCT07284420
Lead Sponsor	argenx
Conditions	AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG)
Enrollment	70 participants
Start Date	2025-12-19
Primary Completion	2028-03-07 (estimated)
Study Completion	2028-03-07 (estimated)
Updated on ClinicalTrials.gov	2026-09-24