A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
“The primary endpoint of ORS was not met in either study.”Read by software from the paper's abstract
mean Overall Response Score (ORS) · week 48
| Group | n | Value |
|---|---|---|
| elezanumab 400mg | 69 | mean ORS -0.2 |
| elezanumab 1800mg | 69 | mean ORS -0.2 |
effect size -0.2
Total participants: 208
Read by software from the paper's abstract
What was tested
Treatment tested
- Elezanumab
Repulsive guidance molecule A inhibitor
Placebo or sham
- placebo
Results by group
Mean Overall Response Score (ORS) at Week 52
Week 52
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0.04 score on a scale | 0.175 (Standard Error) | 59 |
| Elezanumab Dose 1 | -0.17 score on a scale | 0.179 (Standard Error) | 61 |
| Elezanumab Dose 2 | -0.17 score on a scale | 0.177 (Standard Error) | 55 |
Placebo
Elezanumab Dose 1
Elezanumab Dose 2
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 70 | 6 (8.6%) | 1 |
| Elezanumab Dose 1 | 69 | 7 (10.1%) | 0 |
| Elezanumab Dose 2 | 69 | 4 (5.8%) | 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
Mean Overall Response Score (ORS) at Week 52
Week 52
Disability progressionWalking and mobility
Other measures (4)
Disability Improvement Response Rate
Week 52
Disability progressionWalking and mobilityOverall Response Score (ORS)
Week 12
Disability progressionWalking and mobilityOverall Response Score (ORS)
Week 24
Disability progressionWalking and mobilityOverall Response Score (ORS)
Week 36
Disability progressionWalking and mobility
Who could take part
Relapsing and progressive · 18 to 65
Inclusion Criteria: * Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months. * Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS). * Participant has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test. Exclusion Criteria: - Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.
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 evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).
Papers
Results
Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Studies to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Relapsing and Progressive Forms of Multiple Sclerosis.Ann Neurol · 2025
The primary endpoint of ORS was not met in either study.
Read by software from the paper's abstract
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History
Started
Dec 2018
Main results due
Aug 2021
Finished
Sept 2021
Results posted
Dec 2023
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