Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-la...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04660539
Start Date
March 2 2021
End Date
May 28 2024
Last Update
December 27 2024
Active Locations (53)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Miami
Miami, Florida, United States, 33136
3
Columbus Research and Wellness
Columbus, Georgia, United States, 31909
4
University of Chicago
Chicago, Illinois, United States, 60637