Phase
Condition
Multiple Sclerosis
Treatment
Ravulizumab
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be anti-AQP4 Ab-positive and have a diagnosis of NMOSD as definedby the 2015 international consensus diagnostic criteria.
Complement inhibitor treatment-naïve participants must have had at least 1 attack orrelapse in the last 12 months prior to the Screening Period.
Expanded Disability Status Scale (EDSS) score ≤ 7.
Eculizumab-experienced participants must be clinically stable per Investigator for 30 days and have been treated with eculizumab in Study ECU-NMO-303 for at least 90days prior to screening with no missed doses within 2 months prior to Day 1.
Participants who enter the study receiving supportive IST(s) (eg, corticosteroid,azathioprine [AZA], mycophenolate mofetil [MMF], methotrexate [MTX], tacrolimus [TAC], cyclosporin [CsA], or cyclophosphamide [CYC]) for the prevention of relapse,either in combination or monotherapy, must be on a stable dosing regimen of adequateduration prior to Screening and remain on a stable dosing regimen during theScreening Period.
To reduce the risk of meningococcal infection (Neisseria meningitidis), allparticipants must be vaccinated against meningococcal infection.
Documented vaccination for Hib and S pneumoniae at least 14 days prior to Day 1according to national/local guidelines for the applicable age group.
Exclusion
Exclusion Criteria:
Use of rituximab within 3 months prior to screening.
Currently treated with a biologic medications (other than eculizumab) that mayaffect immune system functioning, or has stopped treatment with a biologicmedication that may affect immune system functioning, and 5 half lives of themedication have not elapsed by the time of the Screening Visit.
Use of intravenous immunoglobulin (IVIg) or plasma exchange (PE) within 3 weeksprior to Screening.
Participation in another investigational drug or investigational device study (otherthan Study ECU-NMO-303) within 5 half lives of that investigational product (ifknown) or 30 days before initiation of the first dose of study drug, whichever islonger.
Use of immunomodulatory therapies for multiple sclerosis within 3 months prior toScreening.
Study Design
Connect with a study center
Clinical Trial Site
Edmonton, Alberta T6G 1C9
CanadaActive - Recruiting
Research Site
Edmonton, Alberta T6G 1C9
CanadaActive - Recruiting
Clinical Trial Site
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Research Site
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Clinical Trial Site
Montreal, Quebec H3T 1C5
CanadaActive - Recruiting
Research Site
Montreal, Quebec H3T1C5
CanadaActive - Recruiting
Clinical Trial Site
Le Kremlin-Bicêtre, 94270
FranceActive - Recruiting
Research Site
Le Kremlin-Bicêtre, 94270
FranceActive - Recruiting
Research Site
Marseille, 13005
FranceActive - Recruiting
Clinical Trial Site
Montpellier, 34295
FranceSite Not Available
Research Site
Montpellier, 34295
FranceActive - Recruiting
Research Site
Montpellier Cedex 5, 34295
FranceSite Not Available
Research Site
Bochum, 44791
GermanySite Not Available
Research Site
Giessen, 35392
GermanySite Not Available
Research Site
Catania, 95123
ItalySite Not Available
Research Site
Chieti, 66013
ItalyActive - Recruiting
Research Site
Gallarate, 21013
ItalyActive - Recruiting
Research Site
Roma, 00165
ItalyActive - Recruiting
Clinical Trial Site
Rome, 00165
ItalySite Not Available
Clinical Trial Site
Yokohama, Kanagawa 232-0024
JapanSite Not Available
Research Site
Yokohama-shi, 232-0024
JapanActive - Recruiting
Clinical Trial Site
Goyang-si, Gyeonggi-do 10408
Korea, Republic ofActive - Recruiting
Research Site
Goyang-si, 10408
Korea, Republic ofActive - Recruiting
Clinical Trial Site
Barcelona, 08950
SpainSite Not Available
Research Site
Esplugues de Llobregat, 8950
SpainActive - Recruiting
Research Site
Washington, District of Columbia 20010
United StatesActive - Recruiting
Clinical Trial Site
Miami, Florida 33136
United StatesActive - Recruiting
Research Site
Miami, Florida 33136
United StatesActive - Recruiting
Clinical Trial Site
Boston, Massachusetts 02114
United StatesActive - Recruiting
Research Site
Boston, Massachusetts 02114
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Research Site
Durham, North Carolina 27705
United StatesActive - Recruiting
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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