A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
NCT ID: NCT04660539
Last Updated: 2024-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
119 participants
INTERVENTIONAL
2021-03-02
2024-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Satralizumab Treatment
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
satralizumab
Satralizumab will be administered by SC injection in the abdominal or femoral region at a dose of 120 mg (fixed dose) Q4W for up to 3 years
azathioprine (AZA)
Participants are permitted to use AZA during the study as background immunosuppressive treatment at a maximum dose of 3 milligram per kilogram per day (mg/kg/day)
mycophenolate mofetil (MMF)
Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day
oral corticosteroids
Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day
Interventions
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satralizumab
Satralizumab will be administered by SC injection in the abdominal or femoral region at a dose of 120 mg (fixed dose) Q4W for up to 3 years
azathioprine (AZA)
Participants are permitted to use AZA during the study as background immunosuppressive treatment at a maximum dose of 3 milligram per kilogram per day (mg/kg/day)
mycophenolate mofetil (MMF)
Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day
oral corticosteroids
Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were anti-aquaporin-4 IgG antibody (AQP4-IgG) seropositive at screening in these studies. Participants with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.
Exclusion Criteria
* Evidence of any serious uncontrolled concomitant diseases that may preclude participation including nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
* Known active infection that requires delaying the next satralizumab dose at the time of enrollment
* NMOSD relapse at the time of enrollment
* Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
University of Miami
Miami, Florida, United States
Columbus Research and Wellness
Columbus, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Consultants in Neurology Ltd
Northbrook, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Wayne State University; UHC-4H
Detroit, Michigan, United States
The Neurological Institute PA
Charlotte, North Carolina, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Jefferson Hospital For Neuroscience; Jefferson Neurology Associates
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, , Bulgaria
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, , Bulgaria
MS Clinical Trials Group
Vancouver, British Columbia, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Clinical Hospital Centre Osijek
Osijek, , Croatia
Ruhr Universitat Bochum
Bochum, , Germany
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
Budapest, , Hungary
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicily, Italy
Kyushu University Hospital
Fukuoka, , Japan
Tohoku University Hospital
Miyagi, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Osaka University Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
Hospital Kuala Lumpur
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, , Poland
M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM
Katowice, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii
Lublin, , Poland
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny; Klinika Neurologii
Warsaw, , Poland
Instytut Psychiatrii i Neurologii
Warsaw, , Poland
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, , Poland
San Juan MS Center
Guaynabo, , Puerto Rico
SC Clubul Sanatatii SRL
Campulung Muscel, , Romania
Korea University Anam Hospital
Seoul, , South Korea
Asan Medical Center - PPDS
Seoul, , South Korea
Hospital Clinic de Barcelona
Barcelona, , Spain
Hosp. Clinico San Carlos
Madrid, , Spain
China Medical University Hospital
North Dist., , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Bilim University Medical Faculty Florence Nightingale Hospital
Istanbul, , Turkey (Türkiye)
Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
Dnipro, Katerynoslav Governorate, Ukraine
Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council
Odesa, Kherson Governorate, Ukraine
Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC
Vinnytsia, Podolia Governorate, Ukraine
Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC
Ternopil, Volhynian Governorate, Ukraine
National Hospital For Neurology and Neurosurgery
London, , United Kingdom
Countries
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References
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Bennett JL, Fujihara K, Saiz A, Traboulsee AL, Greenberg BM, Weinshenker BG, Patti F, Kleiter I, Palace J, De Seze J, Evans R, Blondeau K, Klingelschmitt G, Vodopivec I, Rahim M, Yamamura T. Long-Term Efficacy and Safety of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder From the SAkuraMoon Open-Label Extension Study. Neurol Neuroimmunol Neuroinflamm. 2025 Sep;12(5):e200450. doi: 10.1212/NXI.0000000000200450. Epub 2025 Jul 31.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-003413-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WN42349
Identifier Type: -
Identifier Source: org_study_id