Multiple Sclerosis Clinical Trial
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
Summary
The main objective of the 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
Eligibility Criteria
Inclusion criteria
Participants who are aged >=12 years at the time of signing Informed Consent Form
Confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening
Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
Best corrected visual acuity (HCVA) better than 20/800 in each eye at screening
Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
Exclusion criteria
Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study
Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
Participants with positive screening tests for hepatitis B and C
Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
History of severe allergic reaction to a biologic agent
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 83 Locations for this study
Birmingham Alabama, 35249, United States
Orange California, 92868, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Gainesville Florida, 32608, United States
Jacksonville Florida, 32207, United States
Chicago Illinois, 60611, United States
Northbrook Illinois, 60062, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Owosso Michigan, 48867, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
New York New York, 10003, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44915, United States
Columbus Ohio, 43214, United States
Greenville South Carolina, 29605, United States
Houston Texas, 77030, United States
Milwaukee Wisconsin, 53226, United States
Camperdown New South Wales, 2050, Australia
New Lambton New South Wales, 2305, Australia
Randwick New South Wales, 2031, Australia
St Leonards New South Wales, 2065, Australia
Box Hill Victoria, 3128, Australia
Parkville Victoria, 3050, Australia
Nedlands Western Australia, 6009, Australia
Curitiba PR, 81210, Brazil
Rio de Janeiro RJ, 20270, Brazil
Porto Alegre RS, 90610, Brazil
Sao Paulo SP, 01228, Brazil
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5B 1, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3A 2, Canada
Beijing City , 10003, China
Beijing City , 10004, China
Beijing City , 10005, China
Changsha City , 41000, China
Chengdu City , 61004, China
Chongqing , 40001, China
Guangzhou , 51063, China
Hangzhou City , 31001, China
Shanghai City , 20004, China
Shanghai , 20110, China
Taiyuan , 03000, China
Tianjin , 30005, China
Wuhan City , 43003, China
Bron , 69677, France
Paris , 75013, France
Toulouse , 31059, France
Berlin , 10117, Germany
Bochum , 44791, Germany
Datteln , 45711, Germany
Düsseldorf , 40225, Germany
Kiel , 24105, Germany
Mannheim , 68167, Germany
Munich , 81377, Germany
Jerusalem , 91120, Israel
Roma Lazio, 00165, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Pavia Lombardia, 27100, Italy
Orbassano Piemonte, 10043, Italy
Catania Sicilia, 95123, Italy
Verona Veneto, 37134, Italy
Chiba , 260-8, Japan
Fukuoka , 812-8, Japan
Fukushima , 963-8, Japan
Hyogo , 650-0, Japan
Kanagawa , 252-0, Japan
Miyagi , 980-8, Japan
Miyagi , 983-8, Japan
Osaka , 565-0, Japan
Saitama , 350-8, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Tokyo , 160-0, Japan
Tokyo , 160-8, Japan
Tokyo , 162-8, Japan
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.