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

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
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 (empasiprubart). The maximum study duration for participants is up to 49 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
RECRUITING
Scottsdale
California
The Neurology Group
RECRUITING
Pomona
University of California San Francisco
RECRUITING
San Francisco
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Washington, D.c.
Medstar Health Research Institute
RECRUITING
Washington D.c.
Florida
Healthcare Innovations Institute, LLC
RECRUITING
Coral Springs
University of South Florida
RECRUITING
Tampa
Indiana
Indiana University Health Neuroscience Center
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
RECRUITING
Fairway
Maryland
Perelman Center for Advanced Medicine
RECRUITING
Columbia
New York
Dent Neurologic Institute Amherst
RECRUITING
Amherst
Columbia University Medical Center
RECRUITING
New York
Ohio
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Oregon
Oregon Health and Science University
RECRUITING
Portland
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
NeuroCarePlus
RECRUITING
Houston
Other Locations
Australia
Royal Melbourne Hospital
RECRUITING
Parkville
Gold Coast University Hospital
RECRUITING
Southport
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Universitätsklinikum AKH Wien
RECRUITING
Vienna
Canada
Neuro-Outaouais Clinic
RECRUITING
Gatineau
China
Huashan Hospital Fudan University
RECRUITING
Shanghai
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
Germany
Universität Georg August
RECRUITING
Göttingen
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
RECRUITING
Lübeck
Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH
RECRUITING
Potsdam
Japan
National Center of Neurology and Psychiatry
RECRUITING
Kodaira
Nagoya University Hospital
RECRUITING
Nagoya
Yamaguchi University Hospital
RECRUITING
Ube
Latvia
Pauls Stradins Clinical University Hospital
RECRUITING
Riga
Norway
Oslo Universitetssykehus HF, Ullevål
RECRUITING
Oslo
Poland
MICS Centrum Medyczne Bydgoszcz
RECRUITING
Bydgoszcz
Centrum Medyczne Neurologia Slaska
RECRUITING
Katowice
Galen Clinic -- Lublin
RECRUITING
Lublin
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Quironsalud Malaga
RECRUITING
Málaga
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2029-12
Participants
Target number of participants: 115
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov