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An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)
CompletedPhase 3NMOSDNCT020031442013-001151-12

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Baseline up to end of study (up to 6.5 years)

GroupValueIntervalNumber analysed
Placebo/Eculizumab41 Participants41
Eculizumab/Eculizumab70 Participants78
Placebo/Eculizumab14 Participants41
Eculizumab/Eculizumab26 Participants78

Placebo/Eculizumab

41

Eculizumab/Eculizumab

70

Placebo/Eculizumab

14

Eculizumab/Eculizumab

26

Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality

Baseline up to end of study (up to 6.5 years)

GroupValueIntervalNumber analysed
Placebo/Eculizumab4 Participants41
Eculizumab/Eculizumab5 Participants78
Placebo/Eculizumab0 Participants41
Eculizumab/Eculizumab1 Participants78
Placebo/Eculizumab4 Participants41
Eculizumab/Eculizumab5 Participants78

Number of Participants With An On-trial Relapse as Determined by The Treating Physician

Baseline up to end of study (up to 6.5 years)

GroupValueIntervalNumber analysed
Placebo/Eculizumab5 Participants41
Eculizumab/Eculizumab8 Participants78

Placebo/Eculizumab

5

Eculizumab/Eculizumab

8

On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician

Baseline up to end of study (up to 6.5 years)

GroupValueIntervalNumber analysed
Placebo/Eculizumab0.128 relapses/years on study0.4576 (Standard Deviation)41
Eculizumab/Eculizumab0.061 relapses/years on study0.2186 (Standard Deviation)78

Placebo/Eculizumab

0.128

Eculizumab/Eculizumab

0.061

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo/Eculizumab4114 (34.1%)0
Eculizumab/Eculizumab7826 (33.3%)0
Eculizumab (Combined Total)11940 (33.6%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

    Baseline up to end of study (up to 6.5 years)

    Safety

  • Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality

    Baseline up to end of study (up to 6.5 years)

  • Number of Participants With An On-trial Relapse as Determined by The Treating Physician

    Baseline up to end of study (up to 6.5 years)

    Relapses

  • On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician

    Baseline up to end of study (up to 6.5 years)

    Relapses

  • - Safety: Trial emergent adverse effects

    Safety

Other measures (6)

  • Change From Baseline in Expanded Disability Status Scale (EDSS) Score

    Baseline, Weeks 52, 104 and 156

    Disability progressionFatigueBladder, bowel and sexual function

  • Change From Baseline in Modified Rankin Scale (mRS) Score

    Baseline, Weeks 52, 104 and 156

  • Change From Baseline in Hauser Ambulation Index (HAI) in Participants With Abnormal Baseline Ambulatory Function

    Baseline, Weeks 52, 104 and 156

    Walking and mobility

  • Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension Visual Analog Scale (EQ-5D VAS) Health Status Score

    Baseline, Weeks 52, 104 and 156

    Quality of life (reported by participants)

  • Change From Baseline in Kurtzke Visual Functional System Scores (FSS) in Participants With Abnormal Baseline Visual Function

    Baseline, Weeks 52, 104 and 156

    Disability progressionVisionFatigue

  • - On-Trial relapse

    Relapses

Who could take part

NMOSD · 18 and over

Key Inclusion Criteria: 1. Patient completed the ECU-NMO-301 trial 2. Patient has given written informed consent Key Exclusion Criteria: 1. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug 2. Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.

Papers

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Related trials

History

    1. Started

      Jan 2015

    2. Main results due

      Jul 2021

    3. Finished

      Jul 2021

    4. Results posted

      Aug 2022

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