Phase 3
N=119
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
Neuromyelitis Optica · Neuromyelitis Optica Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02003144 ↗Enrolled (actual)
119
Serious AEs
33.6%
Results posted
Aug 2022
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events — 41; 70; 14; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- eculizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events |
41; 70; 14; 26 | — |
| PRIMARY Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality |
4; 5; 0; 1; 4; 5 | — |
| PRIMARY Number of Participants With An On-trial Relapse as Determined by The Treating Physician |
5; 8 | — |
| PRIMARY On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician |
0.128; 0.061 | — |
| SECONDARY Change From Baseline in Expanded Disability Status Scale (EDSS) Score |
4.34; 3.97; -0.24; 0.01; -0.39; -0.11 | — |
| SECONDARY Change From Baseline in Modified Rankin Scale (mRS) Score |
2.39; 1.88; -0.27; -0.04; -0.41; -0.14 | — |
| SECONDARY Change From Baseline in Hauser Ambulation Index (HAI) in Participants With Abnormal Baseline Ambulatory Function |
2.83; 2.35; -0.44; 0.08; -0.57; 0.07 | — |
| SECONDARY Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension Visual Analog Scale (EQ-5D VAS) Health Status Score |
62.00; 72.27; 2.22; -0.78; 0.05; 1.28 | — |
| SECONDARY Change From Baseline in Kurtzke Visual Functional System Scores (FSS) in Participants With Abnormal Baseline Visual Function |
3.75; 3.60; -0.08; -0.06; -0.13; -0.10 | — |
Summary
The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.
Eligibility Criteria
Key Inclusion Criteria
- Patient completed the ECU-NMO-301 trial
- Patient has given written informed consent
Key Exclusion Criteria
- Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
- Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial
Data sourced from ClinicalTrials.gov (NCT02003144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.