A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
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ClinicalTrials.gov Identifier: NCT04660539 |
Recruitment Status :
Active, not recruiting
First Posted : December 9, 2020
Last Update Posted : December 8, 2022
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | |||||
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First Submitted Date ICMJE | November 24, 2020 | ||||
First Posted Date ICMJE | December 9, 2020 | ||||
Last Update Posted Date | December 8, 2022 | ||||
Actual Study Start Date ICMJE | March 2, 2021 | ||||
Estimated Primary Completion Date | May 25, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) | ||||
Official Title ICMJE | 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) | ||||
Brief Summary | This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in patrticipants 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Neuromyelitis Optica Spectrum Disorder | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Satralizumab Treatment
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
119 | ||||
Original Estimated Enrollment ICMJE |
127 | ||||
Estimated Study Completion Date ICMJE | May 25, 2024 | ||||
Estimated Primary Completion Date | May 25, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Bulgaria, Canada, Croatia, Germany, Hungary, Italy, Japan, Korea, Republic of, Malaysia, Poland, Puerto Rico, Romania, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04660539 | ||||
Other Study ID Numbers ICMJE | WN42349 2020-003413-35 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Hoffmann-La Roche | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hoffmann-La Roche | ||||
Verification Date | December 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |