A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in

An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

CompletedPhase 2Relapsing MSNCT014332502011-001629-25

What it found

Results posted, not judged

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

Results by group

Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments

97 weeks

GroupValueIntervalNumber analysed
AIN/AIN12 participants22
PBO/AIN8 participants17

AIN/AIN

12

PBO/AIN

8

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo(Core)/AIN457(Extension)170 (0.0%)
AIN457(Core)/AIN457(Extension)222 (9.1%)

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

  • Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments

    97 weeks

    Safety

  • Safety and tolerability of AIN457

    Safety

Other measures (6)

  • Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)

    week 97

    Disability progressionRelapses

  • Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI

    weeks 13,25,37,53,73 and 97

    MRI lesions

  • Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI

    weeks 13,25,37,53,73 and 97

    MRI lesions

  • Change in Brain Volume at End of Study.

    week 97

    Brain volume loss

  • Measure of Disability: Expanded Disability Status Scale (EDSS).

    Baseline to week 97

    Disability progressionBladder, bowel and sexual function

  • Long term efficacy of AIN457

Who could take part

Relapsing MS · 18 to 55

Show the full criteria

Inclusion criteria

1. Was exposed to AIN457 or placebo in study CAIN457B2201 and completed the CAIN457B2201 study, up to at and including Visit 10 (week 24).

Exclusion criteria

1. Have been treated with: * immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal. * immunoglobulins and/or monoclonal antibodies (with the exception of AIN457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of B cell depletion after rituximab treatment). 2. Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects. 3. Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment. 4. A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome. 5. Current severe depression. 6. Pregnant or nursing (lactating) women. 7. Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin). 8. A new diagnosis of diabetes 9. Positive testing for tuberculosis (QuantiFeron or chest X-ray). 10. Subjects with clinically significant cardiac abnormalities 11. Unable or unwilling to undergo multiple venipunctures 12. Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI. 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

The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.

Papers

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    History

      1. Started

        Feb 2012

      2. Main results due

        Jun 2014

      3. Finished

        Jun 2014

      4. Results posted

        Mar 2016

      Assembled by software from public sources.