Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

Official Title
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A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Placebo
* Drug: AIN457


Participation Criteria
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Eligibility Criteria
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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.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457 low dose<br>AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis. | Drug: AIN457<br>* AIN457 will be administered at predefined visits over the 6-month treatment phase.<br>|
| Placebo Comparator: Placebo<br>Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2). | Drug: Placebo<br>* Placebo will be administered at predefined visits over the 6-month treatment phase.<br>|
| Experimental: AIN457 middle dose<br>AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis | Drug: AIN457<br>* AIN457 will be administered at predefined visits over the 6-month treatment phase.<br>|
| Experimental: AIN457 high dose<br>AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis. | Drug: AIN457<br>* AIN457 will be administered at predefined visits over the 6-month treatment phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions | Due to early termination this trial was not powered for efficacy no statistical analysis was performed | Months 3, 4, 5, 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Number of particpants with Adverse events as a measure of safety and tolerability | 6 months | 
| Annualized Relapse Rate | Due to early termination this trial was not powered for efficacy no statistical analysis was performed | 6 Months | 
| Combined Unique Active Lesions (CUAL) | Due to early termination this trial was not powered for efficacy no statistical analysis was performed | Months 3, 4, 5, 6 | 
| Change in Total Volume of T2-weighted Lesions | Due to early termination this trial was not powered for efficacy no statistical analysis was performed | Baseline, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Relapsing Multiple Sclerosis, AIN457, Secukinumab, Magnetic Resonance Imaging, Relapsing Remitting Multiple Sclerosis, Autoimmune Diseases, Nervous System Diseases, Immune System Diseases, Demyelinating Diseases