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

NCT04660539

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Neuromyelitis Optica Spectrum Disorder

Interventions: satralizumab, azathioprine (AZA), mycophenolate mofetil (MMF), oral corticosteroids

Countries: United States, Bulgaria, Canada, Croatia, Germany, Hungary, Italy, Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
Locations (53)
  • Birmingham, Alabama, United States
  • Miami, Florida, United States
  • Columbus, Georgia, United States
  • Chicago, Illinois, United States
  • Northbrook, Illinois, United States
  • Peoria, Illinois, United States
  • Kansas City, Kansas, United States
  • Detroit, Michigan, United States
  • Charlotte, North Carolina, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Dallas, Texas, United States
  • Round Rock, Texas, United States
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Vancouver, British Columbia, Canada
  • Montreal, Quebec, Canada
  • Osijek, Croatia
  • Bochum, Germany
  • Budapest, Hungary
  • Rome, Lazio, Italy
  • Catania, Sicily, Italy
  • Fukuoka, Japan
  • Miyagi, Japan
  • Niigata, Japan
  • Osaka, Japan
  • Osaka, Japan
  • Tokyo, Japan
  • Tokyo, Japan
  • + 23 more on CT.gov