At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 95 enrolled
Drug / intervention
Satralizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
In Brief
A Phase 3 clinical trial evaluating Satralizumab and Placebo for Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD). Completed, enrolled 95 participants across 58 sites in 15 countries.
Detailed Summary
The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Canada, Croatia, Georgia, Italy, Malaysia, Philippines, Poland, Puerto Rico, Romania, South Korea, Taiwan, Turkey (Türkiye), Ukraine, United States
CollaboratorsChugai Pharmaceutical
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartAug 2014
Primary CompletionOct 2018
Study CompletionJan 2022
TodayJul 2026
First PostedFeb 27, 2014
Enrollment StartAug 5, 2014
Primary CompletionOct 12, 2018
Study CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.3 years ago
Interventions
Satralizumabdrug
Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Placebodrug
Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).