Actively Recruiting
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Led by Hoffmann-La Roche · Updated on 2026-05-08
152
Participants Needed
82
Research Sites
298 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
C
Chugai Pharmaceutical
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 12 years or older at the time of consent
- Confirmed diagnosis of MOGAD with at least one relapse in the past 12 months or two attacks in the past 24 months
- Expanded Disability Status Scale (EDSS) score between 0 and 6.5 at screening
- High-contrast visual acuity better than 20/800 in each eye at screening
- Receiving no treatment or ongoing chronic immunosuppressant treatment for MOGAD at screening
- Women of childbearing potential agree to abstain or use adequate contraception during treatment and for at least 3 months after the last dose
You will not qualify if you...
- Presence of aquaporin-4-antibodies immunoglobin G (AQP4-IgG) in serum
- History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
- Other diseases requiring treatment with immunosuppressants or corticosteroids at doses greater than 20 mg prednisone equivalent per day for more than 21 days during the study
- Pregnancy, breastfeeding, or intention to become pregnant during the study or within 3 months after treatment
- Active or recurrent bacterial, viral, fungal, mycobacterial, or other infections at baseline
- Evidence of latent or active tuberculosis (except those receiving preventive treatment)
- Positive screening tests for hepatitis B or C
- Receipt of live or live attenuated vaccine within 6 weeks before baseline
- History of severe allergic reaction to a biologic agent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 82 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
Withdrawn
3
University of California Irvine - Manchester Pavilion
Irvine, California, United States, 92697
Active, Not Recruiting
4
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora, Colorado, United States, 80045
Active, Not Recruiting
5
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Active, Not Recruiting
6
University of Florida College of Medicine Gainesville
Gainesville, Florida, United States, 32608
Active, Not Recruiting
7
Nemours Children's Clinic - of the Nemours Foundation
Jacksonville, Florida, United States, 32207
Withdrawn
8
Meridian Clinical Research, LLC
Savannah, Georgia, United States, 31406
Withdrawn
9
Northwestern University
Chicago, Illinois, United States, 60611
Withdrawn
10
Consultants in Neurology Ltd
Northbrook, Illinois, United States, 60062
Withdrawn
11
Johns Hopkins
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
13
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso, Michigan, United States, 48867
Active, Not Recruiting
14
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55902
Active, Not Recruiting
15
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Active, Not Recruiting
16
NYU Langone
New York, New York, United States, 10003
Active, Not Recruiting
17
Duke University Medical Center
Durham, North Carolina, United States, 27710
Withdrawn
18
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Active, Not Recruiting
19
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44915
Active, Not Recruiting
20
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Withdrawn
21
Premier Neurology
Greenville, South Carolina, United States, 29605
Completed
22
Baylor College of Medicine
Houston, Texas, United States, 77030
Withdrawn
23
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Completed
24
Brain and Mind Research Institute
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
25
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
Withdrawn
26
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Withdrawn
27
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Withdrawn
28
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Withdrawn
29
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
30
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Withdrawn
31
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Withdrawn
32
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
33
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
34
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
35
Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil, 01228-200
Actively Recruiting
36
Hospital Universitario Gaffree e Guinle
Rio de Janeiro, Brazil, 20270-004
Actively Recruiting
37
London Health Sciences Centre Uni Campus
London, Ontario, Canada, N6A 5A5
Withdrawn
38
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
39
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Withdrawn
40
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Withdrawn
41
MUCH - Montreal Neurological Institute & Hospital
Montreal, Quebec, Canada, H3A 2B4
Actively Recruiting
42
Hopital Pierre Wertheimer
Bron, France, 69677
Actively Recruiting
43
CH de Bicêtre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
44
CHU de Toulouse - Hôpital Purpan
Toulouse, France, 31059
Withdrawn
45
NeuroCure Clinical Research Center (NCRC)
Berlin, Germany, 10117
Active, Not Recruiting
46
St. Josef-Hospital, Klinik für Neurologie
Bochum, Germany, 44791
Active, Not Recruiting
47
Vestische Kinder- und Jugendklinik Datteln
Datteln, Germany, 45711
Actively Recruiting
48
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Active, Not Recruiting
49
Neurology UKSH Campus Kiel
Kiel, Germany, 24105
Active, Not Recruiting
50
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Active, Not Recruiting
51
Klinikum Großhadern, LMU
Munich, Germany, 81377
Active, Not Recruiting
52
Hadassah University Hospital Ein Kerem
Jerusalem, Israel, 9112001
Active, Not Recruiting
53
Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy, 00165
Withdrawn
54
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Withdrawn
55
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy, 20133
Withdrawn
56
Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy, Italy, 27100
Actively Recruiting
57
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
Orbassano, Piedmont, Italy, 10043
Actively Recruiting
58
AOU Policlinico V. Emanuele - P.O G. Rodolico
Catania, Sicily, Italy, 95123
Actively Recruiting
59
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Veneto, Italy, 37134
Actively Recruiting
60
Chiba University Hospital
Chiba, Japan, 260-8677
Actively Recruiting
61
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
62
Southern Tohoku Medical Clinic
Fukushima, Japan, 963-8052
Actively Recruiting
63
Kobe University Hospital
Hyōgo, Japan, 650-0017
Actively Recruiting
64
Kitasato University Hospital
Kanagawa, Japan, 252-0375
Actively Recruiting
65
Tohoku University Hospital
Miyagi, Japan, 980-8574
Actively Recruiting
66
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Japan, 983-8512
Actively Recruiting
67
The University of Osaka Hospital
Osaka, Japan, 565-0871
Actively Recruiting
68
Saitama Medical Center
Saitama, Japan, 350-8550
Active, Not Recruiting
69
The Jikei University Hospital
Tokyo, Japan, 105-8471
Actively Recruiting
70
Juntendo University Hospital
Tokyo, Japan, 113-8431
Actively Recruiting
71
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Actively Recruiting
72
Keio University Hospital
Tokyo, Japan, 160-8582
Actively Recruiting
73
Tokyo Women's Medical University Hospital
Tokyo, Japan, 162-8666
Withdrawn
74
Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice, Poland, 40-123
Active, Not Recruiting
75
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688
Withdrawn
76
Centrum Medyczne "MEDYK"
Rzeszów, Poland, 35-055
Withdrawn
77
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
Warsaw, Poland, 02-097
Actively Recruiting
78
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland, 04-730
Withdrawn
79
SPSK nr 1
Zabrze, Poland, 41-800
Active, Not Recruiting
80
National Cancer Center
Goyang-si, South Korea, 10408
Active, Not Recruiting
81
Seoul National University Hospital
Seoul, South Korea, 03080
Active, Not Recruiting
82
Samsung Medical Center
Seoul, South Korea, 06351
Active, Not Recruiting
Research Team
R
Reference Study ID Number: WN43194 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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