Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Study terminated early based upon development of another anti-IL17 fully human monoclonal antibody with better potential for treating MS patients
What was tested
Treatment tested
- Secukinumab
Interleukin 17A inhibitor
Placebo or sham
- Placebo
Results by group
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| AIN457 15 mg/kg | 6 | 0 (0.0%) | |
| AIN457 7 mg/kg | 8 | 1 (12.5%) | |
| AIN457 3 mg/kg | 8 | 0 (0.0%) | |
| Placebo | 6 | 0 (0.0%) |
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
Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions
Months 3, 4, 5, 6
MRI lesionsTo define the efficacy of AIN457, relative to placebo, in reducing the cumulative number of new Gadolinium-enhancing T1-weighted lesions recorded on all available MRI scans
MRI lesions
Other measures (5)
Annualized Relapse Rate
6 Months
RelapsesCombined Unique Active Lesions (CUAL)
Months 3, 4, 5, 6
MRI lesionsChange in Total Volume of T2-weighted Lesions
Baseline, Month 6
MRI lesionsNumber of Particpants With Adverse Events as a Measure of Safety and Tolerability
6 months
Safety- To evaluate the safety and tolerability of three doses of AIN457, relative to placebo, in patients with relapsing multiple sclerosis
Safety
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria: * Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria * Disease duration of 10 years or less * At least one relapse in the last year * EDSS score 0 to 5.0 at entry Exclusion Criteria: * Active chronic disease of the immune system other than multiple sclerosis * History of malignancy within the past 5 years * Active systemic bacterial, viral or fungal infections * Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s) * Any medically unstable condition * Unable to undergo MRI scans or repeated blood tests * Pregnant or nursing females * Women of child-bearing potential must use reliable forms of contraception * Other protocol-defined inclusion/exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
Papers
Loading reviews and guidelines…
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History
Started
Jun 2013
Main results due
Apr 2014
Finished
Apr 2014
Results posted
Jun 2015
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