Status:
RECRUITING
A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
Lead Sponsor:
argenx
Conditions:
Multifocal Motor Neuropathy (MMN)
MMN
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 (empasiprub...
Eligibility Criteria
Inclusion Criteria:
- Is at least 18 years of age and the local legal age of consent for clinical studies
- Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines
- Has responded to IVIg in the past 5 years.
- Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle
- Is receiving a maintenance regimen (no change in frequency, and no change in dose >10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks)
- Minimum converted weekly IVIg dose of ≥0.125 g/kg
- Has documented immunization against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first study drug administration
Exclusion Criteria:
- Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition that would confound the study results or put the participant at undue risk
- Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
Key Trial Info
Start Date :
December 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06742190
Start Date
December 18 2024
End Date
December 1 2029
Last Update
March 13 2026
Active Locations (109)
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1
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
Scottsdale, Arizona, United States, 85251
2
The Neurology Group
Pomona, California, United States, 91767
3
Samir Macwan, M.D., Inc.
Rancho Mirage, California, United States, 92270
4
University of California San Francisco
San Francisco, California, United States, 94143