A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Multifocal Motor Neuropathy (MMN)
MMN
Спонсор: argenx
Налично на:
БГ
Обобщение
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.
More information can be found here: https://clinicaltrials.argenx.com/empassion
Кой може да участва
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)
Места на провеждане
22
Австралия (1)
Royal Melbourne Hospital
Parkville
ACTIVE_NOT_RECRUITING
Белгия (1)
UZ Antwerpen
Edegem
ACTIVE_NOT_RECRUITING
Бразилия (1)
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto
ACTIVE_NOT_RECRUITING
Канада (1)
Neuro-Outaouais Clinic
Gatineau
ACTIVE_NOT_RECRUITING
Китай (1)
Huashan Hospital Fudan University
Shanghai
ACTIVE_NOT_RECRUITING
Чехия (1)
Fakultni nemocnice Brno
Brno
ACTIVE_NOT_RECRUITING
Дания (1)
Aarhus Universitetshospital
Aarhus
ACTIVE_NOT_RECRUITING
Франция (1)
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux
ACTIVE_NOT_RECRUITING
Гърция (1)
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári
ACTIVE_NOT_RECRUITING
Италия (1)
Azienda Ospedaliera Universitaria Careggi
Florence
ACTIVE_NOT_RECRUITING
Япония (1)
Juntendo University Hospital
Bunkyō City
ACTIVE_NOT_RECRUITING
Latvia (1)
Pauls Stradins Clinical University Hospital
Riga
ACTIVE_NOT_RECRUITING
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas
ACTIVE_NOT_RECRUITING
Нидерландия (1)
Amsterdam UMC
Amsterdam
ACTIVE_NOT_RECRUITING
Норвегия (1)
Oslo Universitetssykehus HF, Ullevål
Oslo
ACTIVE_NOT_RECRUITING
Полша (1)
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz
ACTIVE_NOT_RECRUITING
Сърбия (1)
University Clinical Center of Serbia
Belgrade
ACTIVE_NOT_RECRUITING
Словакия (1)
Univerzitna nemocnica Bratislava
Bratislava
ACTIVE_NOT_RECRUITING
Испания (1)
Hospital General Universitario Dr. Balmis
Alicante
ACTIVE_NOT_RECRUITING
Швейцария (1)
Inselspital - Universitätsspital Bern
Bern
ACTIVE_NOT_RECRUITING
Великобритания (1)
Queen Elizabeth University Hospital
Glasgow
ACTIVE_NOT_RECRUITING
САЩ (1)
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology