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NCT04660539CompletedPhase 3

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Source: ClinicalTrials.gov · Last updated 27 Dec 2024

Brief summary (registry, in English)

This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
119 (actual)
First submitted
24 Nov 2020
Start date
2 Mar 2021
Primary completion date
28 May 2024
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04660539
EudraCT number
2020-003413-35

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 119
  • From 2 Mar 2021 to the primary completion date, 28 May 2024
  • 53 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug
  • 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

Other illness

  • Known active infection that requires delaying the next satralizumab dose at the time of enrollment

Lab values

  • Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab

Other

  • NMOSD relapse at the time of enrollment

Who the study is looking for

  • Participants aged less than 18 years at the time of informed consent for Study BN40898 can continue treatment with a combination of oral corticosteroids and either AZA or MMF
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Umhat 'Dr. Georgi Stranski', Ead
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PlevenBulgariaUnknown status
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
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SofiaBulgariaUnknown status
"University Multiprofile Hospital for Active Treatment "Aleksandrovska"" EAD"
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SofiaBulgariaUnknown status
Centre Hospitalier de l'Universite de Montreal (CHUM)
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MontrealCanadaUnknown status
MS Clinical Trials Group
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VancouverCanadaUnknown status
Ruhr Universitat Bochum
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BochumGermanyUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hosp. Clinico San Carlos
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MadridSpainUnknown status
National Hospital For Neurology and Neurosurgery
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LondonUnited KingdomUnknown status
Clinical Hospital Centre Osijek
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OsijekCroatiaUnknown status
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
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BudapestHungaryUnknown status
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
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CataniaItalyUnknown status
Azienda Ospedaliera Sant'Andrea
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RomeItalyUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
Tohoku University Hospital
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MiyagiJapanUnknown status
Niigata University Medical & Dental Hospital
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NiigataJapanUnknown status
Kindai University Hospital
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OsakaJapanUnknown status
Osaka University Hospital
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OsakaJapanUnknown status
Tokyo Women's Medical University Hospital
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TokyoJapanUnknown status
National Center of Neurology and Psychiatry
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TokyoJapanUnknown status
Asan Medical Center - PPDS
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SeoulSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Hospital Kuala Lumpur
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Kuala LumpurMalaysiaUnknown status
NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
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KatowicePolandUnknown status
M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM
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KatowicePolandUnknown status
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii
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LublinPolandUnknown status
Międzyleski Szpital Specjalistyczny w Warszawie
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WarsawPolandUnknown status
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny; Klinika Neurologii
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WarsawPolandUnknown status
Instytut Psychiatrii I Neurologii
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WarsawPolandUnknown status
San Juan MS Center
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GuaynaboPuerto RicoUnknown status
SC Clubul Sanatatii SRL
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Campulung MuscelRomaniaUnknown status
China Medical University Hospital
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North Dist.TaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
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DniproUkraineUnknown status
Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council
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OdesaUkraineUnknown status
Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC
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TernopilUkraineUnknown status
Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC
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VinnytsiaUkraineUnknown status
Children's Hospital of Alabama
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BirminghamUnited StatesUnknown status
The Neurological Institute PA
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CharlotteUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
OhioHealth Research Institute
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ColumbusUnited StatesUnknown status
Columbus Research and Wellness
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ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Wayne State University; UHC-4H
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DetroitUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Consultants in Neurology, Ltd
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NorthbrookUnited StatesUnknown status
OSF Saint Francis Medical Center
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PeoriaUnited StatesUnknown status
Jefferson Hospital For Neuroscience; Jefferson Neurology Associates
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PhiladelphiaUnited StatesUnknown status
Central Texas Neurology Consultants
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Round RockUnited StatesUnknown status
Bilim University Medical Faculty Florence Nightingale Hospital
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.