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A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy

Study acronym: Empassion
StatusActive, Not Recruiting
PhasePhase 3
Sponsorargenx
Started2024-12-18
View on ClinicalTrials.gov ↗

Amendment history

2026-05-18
Study Status, Study Design, Outcome Measures, Contacts/Locations v13
Trial status changed: Recruiting → Active, Not Recruiting
Primary endpoint(s) modified1 entry, revised
WasChange from baseline in grip strength (3-day moving average) in the most affected hand at week 24
NowChange from baseline in grip strength (4-week average) in the most affected hand at week 24
Enrollment increased: 115 → 154 participants
Secondary endpoints21 to 22 entries
Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24
Study sitesdetails revised at 109 of 109 sites
2026-03-11
Study Status, Study Description, Contacts/Locations, References v12
Study sites108→109
2026-02-13
Study Status, Contacts/Locations v11
Study sites103→108
2026-01-14
Study Status, Contacts/Locations v10
Study sites98→103
2025-12-15
Study Status, Contacts/Locations v9
Study sites88→98
Show 8 earlier versions
2025-11-17
Study Status, Oversight, Contacts/Locations v8
Study sites55→88
2025-10-16
Study Status, Contacts/Locations v7
Study sites38→55
2025-09-17
Study Status, Contacts/Locations v6
Study sites19→38
2025-08-19
Study Status, Conditions, Study Design, Outcome Measures, Contacts/Locations v5
Enrollment target100→115
Study sites6→19
Secondary endpoints21 entries, revised
Change from baseline in gripMMN-RODS strengthcentile (3-day moving average) in the most affected handscore at week 24
Primary endpoints1 entry, revised
Change from baseline in MMNgrip strength (3-RODSday centilemoving scoreaverage) in the most affected hand at week 24
2025-05-02
Study Identification, Study Status, Contacts/Locations v4
Study sites4→6
Study titlerevised
A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults withWith Multifocal Motor Neuropathy
2025-03-26
Study Status, Contacts/Locations v3
Study sites3→4
2025-02-17
Study Status, Contacts/Locations v2
Study sites2→3
2025-01-10
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12→confirmed 2024-12-18
Study sites0→2
Secondary endpointsdetails revised at 1 of 21 entries
2024-12-16
Original filing
Argenx
56 trials monitored
See 2 trials at risk
The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months. More information can be found here: https://clinicaltrials.argenx.com/empassion
Trial Details
NCT Number NCT06742190
Lead Sponsor argenx
Conditions Multifocal Motor Neuropathy (MMN), MMN
Enrollment 154 participants
Start Date 2024-12-18
Primary Completion 2026-09 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-22