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

Launched by ARGENX · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new treatment called empasiprubart compared to an established treatment known as IVIg in adults with a condition called Multifocal Motor Neuropathy (MMN). MMN is a type of nerve disorder that affects muscle strength. The trial will involve participants who are at least 18 years old and have been diagnosed with MMN, and who have previously responded to IVIg treatment. To qualify, participants must have been on a stable IVIg regimen for a certain period and meet specific health criteria.

Participants in this trial can expect to be involved for up to 49 months. The study has two parts: one part where neither the participants nor the doctors know which treatment they are receiving (this is called double-blinded), and another part where everyone knows they are receiving empasiprubart. This trial is currently recruiting participants of all genders, and it’s important for anyone considering joining to talk to their doctor about whether they meet the eligibility criteria and to understand what being part of the study will involve.

Gender

ALL

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)