A Study to Assess the Safety and Efficacy of Elezanumab When Added to
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive 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
effect size 0.0 (400mg); 0.1 (1800mg)
Total participants: 123
Read by software from the paper's abstract
What was tested
Treatment tested
- Elezanumab
Repulsive guidance molecule A inhibitor
Placebo
- placebo
Results by group
Mean Overall Response Score (ORS)
Week 52
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | -0.74 score on a scale | 0.167 (Standard Error) | 36 |
| Elezanumab 400mg Dose | -0.75 score on a scale | 0.176 (Standard Error) | 31 |
| Elezanumab 1800 mg Dose | -0.64 score on a scale | 0.17 (Standard Error) | 34 |
Placebo
Elezanumab 400mg Dose
Elezanumab 1800 mg Dose
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 | 43 | 2 (4.7%) | 1 |
| Elezanumab 400mg Dose | 40 | 5 (12.5%) | 1 |
| Elezanumab 1800 mg Dose | 40 | 3 (7.5%) | 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)
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
Progressive MS · 18 to 65
Show the full criteria
Inclusion criteria
* Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months. * Evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.
Exclusion criteria
* Treatment with any of the following within the 6 months prior to Screening: natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil; intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral, or intrathecal corticosteroids for the purposes of disease modification. * Treatment with the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab.
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 progressive Multiple Sclerosis (PMS).
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
Feb 2019
Main results due
Jan 2021
Finished
Aug 2021
Results posted
Dec 2023