A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Completed · Phase 3
Conditions studied: Neuromyelitis Optica Spectrum Disorder
In brief
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.
Key facts
- Study ID
- NCT04660539
- Run by
- Hoffmann-La Roche
- People needed
- 119
- Starts
- 2021-03-02
- Expected to finish
- 2024-05-28
- Last updated by the study team
- 2024-12-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- 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
Where it is running
- 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
- Children's Hospital of Alabama — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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