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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2013
INTERVENTION: investigational material(s) Generic name etc : AIN457 INN of investigational material : secukinumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : AIN457 will be administered intravenously. Patients will be randomized to AIN457 Low/Middle/High dose. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Matching placebo will be administered intravenously. CONDITION: Multiple Sclerosis PRIMARY OUTCOME: Cumulative number of new Gadolinium [Gd]‐enhancing T1‐weighted lesions [ Time Frame: Months 3, 4, 5, 6 ]; 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: Annualized relapse rate [ Time Frame: 6 Months ]; 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.; Combined unique active lesions (CUAL) [ Time Frame: Months 3, 4, 5, 6 ]; New Gd‐enhancing T1‐weighted lesions or new/enlarging T2‐weighted lesions avoiding double counting.; Change in total volume of T2‐weighted lesions [ Time Frame: Baseline, Month 6 ]; Mean change in total volume of T2‐weighted lesions at Month 6.; Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline to Month 6 ]; All AE/SAE will be reported in safety section of record. 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
Epistemonikos ID: 467c9cdc9ea61784d9c8644b744d698fb0e63cd1
First added on: Aug 26, 2024