ECU-NMO-304
What it found
No result yet.
What was tested
Treatment tested
- Eculizumab
Complement C5 inhibitor
What it measured
Main measures
The efficacy of eculizumab in anti-AQP4 antibody positive participants with NMOSD measured by Adjudicated On-trial annualized relapse rate (ARR).
Baseline through Week 52
Relapses
Other measures (8)
The efficacy of eculizumab by assessing change from baseline to end of study in Expanded Disability Status Scale (EDSS) Score
Baseline through Week 52
Disability progressionThe efficacy of eculizumab by assessing change from baseline to end of study in Ambulatory Function as Measured by Hauser Ambulation Index (HAI)
Baseline through Week 52
The efficacy of eculizumab by assessing change from baseline to end of study in European Quality of Life 5-Dimension Questionnaire (EQ-5D) Index Score
Baseline through Week 52
Quality of life (reported by participants)Change From Baseline to end of study in EQ-5D Visual Analogue Scale (VAS) Score
Baseline through Week 52
Quality of life (reported by participants)Serum Eculizumab Concentrations Over Time
Baseline through Week 52
Serum Free Complement Component 5 (C5) Concentrations Over Time
Baseline through Week 52
Number of Treatment-emergent Antidrug Antibody (ADA) Positive Participants
Baseline through Week 52
Immune responseTo characterize the overall safety of eculizumab in the treatment of NMOSD
Baseline through Week 52
Safety
Who could take part
NMOSD · 18 to 130
Inclusion Criteria: * Participants with diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria * Anti-AQP4 antibody positive * At least 1 attack or relapse in the last 12 months prior to the Screening Period * EDSS score ≤ 7 * If a participant enters the study receiving IST(s) for relapse prevention, the participant must be on a stable maintenance dose of IST(s) as follows, prior to screening and must remain on that dose for the duration of the study, unless the participant experiences a relapse * Female participants of childbearing potential must have a negative pregnancy test (serum HCG at screening * Male participants are eligible to participate if they agree to the following during the study intervention Treatment Period and for at least 5 months after the last dose of study intervention: * Refrain from donating fresh unwashed semen. PLUS, either, * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR * Must agree to use barrier as detailed below: * Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant. Exclusion Criteria: * Pregnant, breastfeeding, or intending to conceive during the course of the study * Prior history of N meningitidis infection or unresolved meningococcal disease * Any systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics * Presence of fever ≥ 38 C within 7 days prior to study intervention administration on Day 1 * Hypersensitivity to murine proteins or to one of the excipients of study intervention * Use of rituximab, inebilizumab, or other B cell-depleting therapy within 6 months prior to Day 1 and during the study * Use of mitoxantrone or satralizumab within 3 months prior to screening and during the study * Use of IVIg within 3 weeks prior to screening * If a participant enters the study receiving oral corticosteroid(s) with or without other ISTs, the daily corticosteroid dose must be no more than prednisone 20 mg/day (or equivalent) prior to screening and the participant must remain on that dose for the duration of the study or until the participant experiences a relapse (specific medications listed in Section 6.9.1 may be allowed) * Has previously received treatment with C5 inhibitors * Participation in any other investigational drug study or exposure to an investigational drug or device within 5 half-lives of treatment (if known) or 30 days, which is longer, before the first dose administration
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
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History
Started
Jan 2025
Main results due
Dec 2026
Finished
Dec 2026
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