At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 231 enrolled
Drug / intervention
Inebilizumab +1 moredrug
Likely dose
Inebilizumab 300 mgfrom 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 Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.
In Brief
A Phase 3 clinical trial evaluating Inebilizumab and Placebo for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. Completed, enrolled 231 participants across 98 sites in 25 countries.
Detailed Summary
To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Bulgaria, Canada, Colombia, Czechia, Estonia, Germany, Hong Kong, Hungary, Israel, Japan, Mexico, Moldova, New Zealand, Peru, Poland, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartApr 2015
Primary CompletionOct 2018
Study CompletionNov 2020
TodayJul 2026
First PostedJul 25, 2014
Enrollment StartApr 1, 2015
Primary CompletionOct 26, 2018
Study CompletionNov 6, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 11.9 years ago
Interventions
Inebilizumabdrug
Participants will receive IV inebilizumab 300 mg.
Placeboother
Participants will receive IV placebo matched to inebilizumab.