Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Multiple Sclerosis
Enrollment Eligibility
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