A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
Purpose
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.
Condition
- Multifocal Motor Neuropathy (MMN)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A - empasiprubart + IVIg-placebo |
During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm |
|
|
Active Comparator Part A - IVIg + empasiprubart-placebo |
During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm |
|
|
Experimental Part B - empasiprubart |
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg) |
|
Recruiting Locations
Medstar Health Research Institute
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- argenx