B2201
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Secukinumab
Interleukin 17A inhibitor
Placebo or sham
- Placebo
Results by group
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
weeks 4,8,12,16,20,24,28
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| AIN457B | 2.4 Combined Unique Active Lesions | 0–33 | 38 |
| Placebo | 3.2 Combined Unique Active Lesions | 0–16 | 35 |
| AIN457B | 3.9 Combined Unique Active Lesions | 0–47 | 38 |
| Placebo | 5.4 Combined Unique Active Lesions | 0–27 | 35 |
| AIN457B | 5.4 Combined Unique Active Lesions | 0–80 | 38 |
| Placebo | 8.6 Combined Unique Active Lesions | 0–34 | 35 |
| AIN457B | 6.0 Combined Unique Active Lesions | 0–104 | 38 |
| Placebo | 11.5 Combined Unique Active Lesions | 0–50 | 35 |
| AIN457B | 7.7 Combined Unique Active Lesions | 0–118 | 38 |
| Placebo | 13.0 Combined Unique Active Lesions | 0–51 | 35 |
| AIN457B | 7.7 Combined Unique Active Lesions | 0–122 | 38 |
| Placebo | 15.1 Combined Unique Active Lesions | 0–64 | 35 |
| AIN457B | 9.4 Combined Unique Active Lesions | 0–142 | 38 |
| Placebo | 19.9 Combined Unique Active Lesions | 0–110 | 35 |
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 | 35 | 0 (0.0%) | |
| AIN457 10mg/kg | 38 | 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
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
weeks 4,8,12,16,20,24,28
MRI lesionsThe primary endpoint is the number of CUAL during 24 weeks of treatment. It will be analyzed by means of a negative binomial regression model with factor ‘treatment’ (AIN457, placebo) and covariate ‘Gd-enhancing T1 lesions at baseline’ using the log link function and assuming a negative binomial distribution for the target variable.
MRI lesions
Other measures (2)
Raw Number of Cumulative New Gd-T1 Lesions
MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
MRI lesionsRaw Number of Cumulative New Gd-T2 Lesions
MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria: - Exclusion Criteria: -
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis
Papers
Loading reviews and guidelines…
Related trials
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- ZEUS
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History
Started
Dec 2009
Main results due
Apr 2012
Finished
Apr 2012
Results posted
Feb 2015
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