A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis

INTERVENTION: Product Code: BAF312 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: BAF312 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Code: BAF312 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: BAF312 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Code: BAF312 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: BAF312 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Code: BAF312 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: BAF312 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Relapsing‐remitting multiple sclerosis ; MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing‐remitting multiple sclerosis PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the dose response relationship among five doses of BAF312 and placebo during 3 months of treatment in patients with RRMS, as measured by the number of combined unique active [MRI] lesions (CUAL). Primary end point(s): Monthly number of combined unique active MRI lesions (CUAL) during 3 months of treatment. Combined unique active lesions are defined as new gadolinium [Gd]‐enhancing lesions on T1‐weighted MRI scans or new or enlarging lesions on T2‐weighted MRI scans, without double‐counting of lesions.; Secondary Objective: • To evaluate the safety and tolerability (including blood pressure effects) of BAF312 during 6 months and 3 months of treatment in MS patients; • To evaluate the dose response relationship of BAF312 and placebo during 6 months of treatment in patients with RRMS, as measured by CUAL; • To explore the effect of BAF312 on the number of relapses and thereof derived measures (e.g. annualized relapse rate (ARR), proportion of relapse‐free patients); • To explore the correlation of the course of the lymphocyte count with paraclinical (MRI activity) and clinical course; INCLUSION CRITERIA: 1. Patients must give written informed consent before any assessment is performed 2. 18 through 55 years of age inclusive 3. Male or female 4. Females of childbearing potential: • must have a negative pregnancy test at Baseline prior to entry into the double‐blind treatment phase • must simultaneously use two forms of effective contraception (either partner) during the treatment and for one months or one menstrual cycle, whichever is longer after discontinuation of the study drug • if either post‐menopausal for 12 months prior to randomization or surgically sterile (through hysterectomy or bilateral oophorectomy, if documented), are not required to use birth control (refer to Section 8.3 for more details) 5. Diagnosis of MS as defined by revised McDonald criteria (see Appendix 4) 6. A relapsing‐remitting course of disease with • at least 1 documented relapse during the previous year, or • 2 documented relapses during the previous