A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: AIN457
* Drug: AIN457


Participation Criteria
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Eligibility Criteria
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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: 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). 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. Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment. A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome. Current severe depression. Pregnant or nursing (lactating) women. Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin). A new diagnosis of diabetes Positive testing for tuberculosis (QuantiFeron or chest X-ray). Subjects with clinically significant cardiac abnormalities Unable or unwilling to undergo multiple venipunctures Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN 457 Core<br>(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension | Drug: AIN457<br>* (10mg/kg i.v.).<br>* Other names: AIN457 core/ AIN extension;|
| Experimental: AIN457 Placebo Core<br>(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension | Drug: AIN457<br>* (10mg/kg i.v.).<br>* Other names: AIN Placebo / AIN Extension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments | Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome | 97 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI | Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions | weeks 13,25,37,53,73 and 97 | 
| Change in Brain Volume at End of Study. | Change in volume from start to end of study | week 97 | 
| Measure of Disability: Expanded Disability Status Scale (EDSS). | The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. | Baseline to week 97 | 
| Distribution of Patients With Relapses to End of Study (EOS) (All Subjects) | Description: number of relapses based on neurological assessments and EDSS | week 97 | 
| Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI | Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans | weeks 13,25,37,53,73 and 97 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis,, demyelinating autoimmune diseases,, interleukin-17,, monoclonal human antibody