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
- Multiple Sclerosis
- Registration Number
- JPRN-jRCT2080222132
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 380
*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
*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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative number of new Gadolinium [Gd]-enhancing T1-weighted lesions [ Time Frame: Months 3, 4, 5, 6 ]<br>Primary endpoint is the cumulative number of new Gd-enhancing T1-weighted lesions seen on brain MRI scans obtained at Months 3, 4, 5 and 6.
- Secondary Outcome Measures
Name Time Method Annualized relapse rate [ Time Frame: 6 Months ]<br>Annualized relapse rate is total number of relapses divided by total number of days on study, multiplied by 365.25 to obtain the annual rate.<br>Combined unique active lesions (CUAL) [ Time Frame: Months 3, 4, 5, 6 ]<br>New Gd-enhancing T1-weighted lesions or new/enlarging T2-weighted lesions avoiding double counting.<br>Change in total volume of T2-weighted lesions [ Time Frame: Baseline, Month 6 ]<br>Mean change in total volume of T2-weighted lesions at Month 6.<br>Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline to Month 6 ]<br>All AE/SAE will be reported in safety section of record.