Comparing empasiprubart and IVIg for treating multifocal motor neuropathy in adults
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy
This study is testing whether a new treatment called empasiprubart works better than the standard IVIg for adults with multifocal motor neuropathy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | argenx Industry-sponsored |
| Locations | 109 sites (Scottsdale, Arizona and 108 other locations) |
| Trial ID | NCT06742190 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with multifocal motor neuropathy (MMN). It consists of a double-blinded phase where participants receive either empasiprubart or IVIg, followed by an open-label phase where all participants receive empasiprubart. The total duration of participation can last up to 49 months, allowing for thorough assessment of treatment effects. Participants must have a history of responding to IVIg and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of MMN who have previously responded to IVIg treatment.
Not a fit: Patients with other known autoimmune diseases or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with multifocal motor neuropathy, potentially improving their quality of life.
How similar studies have performed: While there have been studies on IVIg for MMN, the specific comparison with empasiprubart represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Scottsdale, Arizona and 108 other locations
- HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology — Scottsdale, Arizona, United States (Active_not_recruiting)
- The Neurology Group — Pomona, California, United States (Active_not_recruiting)
- Samir Macwan, M.D., Inc. — Rancho Mirage, California, United States (Active_not_recruiting)
- University of California San Francisco — San Francisco, California, United States (Active_not_recruiting)
- University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic) — Aurora, Colorado, United States (Active_not_recruiting)
- Yale University School of Medicine — New Haven, Connecticut, United States (Active_not_recruiting)
- Medstar Health Research Institute — Washington D.C., District of Columbia, United States (Active_not_recruiting)
- EZR Research LLC — Boca Raton, Florida, United States (Active_not_recruiting)
- Healthcare Innovations Institute, LLC — Coral Springs, Florida, United States (Active_not_recruiting)
- University of Miami Miller School of Medicine — Miami, Florida, United States (Active_not_recruiting)
- University of South Florida — Tampa, Florida, United States (Active_not_recruiting)
- Northwestern University — Chicago, Illinois, United States (Active_not_recruiting)
- Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States (Active_not_recruiting)
- University of Kansas Medical Center — Fairway, Kansas, United States (Active_not_recruiting)
- Perelman Center for Advanced Medicine — Columbia, Maryland, United States (Active_not_recruiting)
- UC Irvine - MDA ALS and Neuromuscular Center — Columbia, Maryland, United States (Active_not_recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Active_not_recruiting)
- Dent Neurologic Institute Amherst — Amherst, New York, United States (Active_not_recruiting)
- Columbia University Medical Center — New York, New York, United States (Active_not_recruiting)
- University of North Carolina at Chapel Hill — Morrisville, North Carolina, United States (Active_not_recruiting)
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (Active_not_recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Active_not_recruiting)
- National Neuromuscular Research Institute — Austin, Texas, United States (Active_not_recruiting)
- NeuroCarePlus — Houston, Texas, United States (Active_not_recruiting)
- Royal Melbourne Hospital — Parkville, Australia (Active_not_recruiting)
- Gold Coast University Hospital — Southport, Australia (Active_not_recruiting)
- Brain and Mind Center — Sydney, Australia (Active_not_recruiting)
- Princess Alexandra Hospital — Woolloongabba, Australia (Active_not_recruiting)
- Universitätsklinikum AKH Wien — Vienna, Austria (Active_not_recruiting)
- UZ Antwerpen — Edegem, Belgium (Active_not_recruiting)
- UZ Leuven — Leuven, Belgium (Active_not_recruiting)
- Hôpital de la Citadelle — Liège, Belgium (Active_not_recruiting)
- Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto — Ribeirão Preto, Brazil (Active_not_recruiting)
- Sociedade de Ensino Superior Estacio de Sa Ltda — Rio de Janeiro, Brazil (Active_not_recruiting)
- Escola Bahiana de Medicina e Saude Publica — Salvador, Brazil (Active_not_recruiting)
- PSEG Centro de Pesquisa Clínica — São Paulo, Brazil (Active_not_recruiting)
- Neuro-Outaouais Clinic — Gatineau, Canada (Active_not_recruiting)
- London Health Sciences Centre — London, Canada (Active_not_recruiting)
- St. Paul's Neurology Associates — Vancouver, Canada (Active_not_recruiting)
- Huashan Hospital Fudan University — Shanghai, China (Active_not_recruiting)
- Fakultni nemocnice Brno — Brno, Czechia (Active_not_recruiting)
- Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia (Active_not_recruiting)
- Vseobecna Fakultni Nemocnice V Praze — Prague, Czechia (Active_not_recruiting)
- Aarhus Universitetshospital — Aarhus, Denmark (Active_not_recruiting)
- Rigshospitalet-Inge Lehmanns Vej 8 — Copenhagen, Denmark (Active_not_recruiting)
- CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France (Active_not_recruiting)
- CHU de Brest - Hôpital La Cavale Blanche — Brest, France (Active_not_recruiting)
- Hospices Civils de Lyon - Hôpital Pierre Wertheimer — Bron, France (Active_not_recruiting)
- AP-HP - Hôpital Bicêtre — Le Kremlin-Bicêtre, France (Active_not_recruiting)
- Hôpital Roger Salengro — Lille, France (Active_not_recruiting)
+59 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: clinicaltrials@argenx.com
- Phone: 857-350-4834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.