Clinical Trials
Empasiprubart
Study Status
Active Recruiting
ARGX-117-2302
Clinicaltrials.Gov Number
NCT06742190
Multifocal motor neuropathy (MMN) is a rare but serious chronic disorder that affects the nerves responsible for controlling muscle movement, mainly in the hands, forearms, and lower legs. Over time, it causes progressive muscle weakness that could eventually lead to considerable disability. This may result in irreversible functional impairment and fatigue, which often impacts a person’s physical health, psychological health, social life, and occupation.
*The investigational study drug has not been approved by any regulatory agency for use in MMN as efficacy and safety have not been established.
You may be eligible to participate if you:
Screening - Up to 15 weeks
Treatment - Part A 24 weeks, Part B 24 months
Follow up - 15 months
The study will be conducted in two parts, Part A and Part B.
In Part A, enrolled participants will be randomly assigned to two separate treatment groups to receive either:
In Part B, all participants will receive empasiprubart.
Study Part A is blinded, meaning that neither the study participant nor the study team will know which study treatment the participant is receiving. Participants never receive placebo-only treatments. Placebos are always combined with either empasiprubart or IVIg. Enrolled participants will be asked to remain in the study for up to 49 months (nearly 4 years). During this period, study participants will need to visit the study site up to 48 times. This will include up to 15 weeks of screening, a 24-week treatment period (Part A), a 24-month open-label extension period (Part B), and a 15-month safety follow-up period after the last dose of the study drug is administered. The investigational study drug will be administered monthly, the IVIg treatment schedule will remain the same as the standard treatment routine the participant was on prior to starting the study. Both are given intravenously (in a vein in your arm).
The clinical study sites are located across the world. Discover open study sites on the map.