CHANGE-MS
What it found
The main measure did not show a significant benefit.
“The primary endpoint was not met.”Read by software from the paper's abstract
reduction of cumulative gadolinium-enhancing T1-lesions in brain magnetic resonance imaging (MRI) scans at week 24 · week 24
Total participants: 270
Read by software from the paper's abstract
What was tested
Treatment tested
- Temelimab
Syncytin-1 inhibitor
Placebo or sham
- Placebo
What it measured
Main measures
Cumulative number of Gd-enhancing T1 lesions in brain MRI
Week 12 to 24
MRI lesionsCumulative number of Gd-enhancing T1 lesions measured using repeated MRI assessments from Week 12 to 24.
MRI lesions
Other measures (1)
- Cumulative T2 lesions and CUAL.
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Main Inclusion Criteria: * For male or female with reproductive potential, use of reliable means of contraception; * RRMS according to the 2010 revised McDonald criteria; * Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months; * EDSS score \< 6.0. Main Exclusion Criteria: * Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening; * Pregnant and nursing women.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis (MS). This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.
Papers
Results
Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study.Mult Scler · 2022
The primary endpoint was not met.
Read by software from the paper's abstract
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History
Started
Apr 2016
Main results due
Aug 2017
Finished
Dec 2017
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