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
- Diseases
- Neuromyelitis optica (NMOSD)
- 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
Sites (53)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Umhat 'Dr. Georgi Stranski', Ead Coordinator of this site? Confirm its status | Pleven | Bulgaria | Unknown status |
| Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| "University Multiprofile Hospital for Active Treatment "Aleksandrovska"" EAD" Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| MS Clinical Trials Group Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Ruhr Universitat Bochum Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Clinico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| National Hospital For Neurology and Neurosurgery Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Clinical Hospital Centre Osijek Coordinator of this site? Confirm its status | Osijek | Croatia | Unknown status |
| Jahn Ferenc Del-Pesti Korhaz es Rendelointezet Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Ospedaliera Sant'Andrea Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Miyagi | Japan | Unknown status |
| Niigata University Medical & Dental Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Tokyo Women's Medical University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| National Center of Neurology and Psychiatry Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Asan Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hospital Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis" Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Międzyleski Szpital Specjalistyczny w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny; Klinika Neurologii Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Instytut Psychiatrii I Neurologii Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| San Juan MS Center Coordinator of this site? Confirm its status | Guaynabo | Puerto Rico | Unknown status |
| SC Clubul Sanatatii SRL Coordinator of this site? Confirm its status | Campulung Muscel | Romania | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | North Dist. | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council Coordinator of this site? Confirm its status | Odesa | Ukraine | Unknown status |
| Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC Coordinator of this site? Confirm its status | Ternopil | Ukraine | Unknown status |
| Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| The Neurological Institute PA Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| OhioHealth Research Institute Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Columbus Research and Wellness Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Wayne State University; UHC-4H Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Consultants in Neurology, Ltd Coordinator of this site? Confirm its status | Northbrook | United States | Unknown status |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Jefferson Hospital For Neuroscience; Jefferson Neurology Associates Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Central Texas Neurology Consultants Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Bilim University Medical Faculty Florence Nightingale Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.