Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis

INTERVENTION: Product Name: LY2127399 Product Code: LY2127399 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/a CAS Number: N/a Current Sponsor code: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐120 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: Relapsing‐Remitting Multiple Sclerosis ; MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing‐remitting multiple sclerosis PRIMARY OUTCOME: Main Objective: Primary Objective; The primary objective of this study is to test the hypothesis that subjects with RRMS in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)‐enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group. Primary end point(s): is to test the hypothesis that subjects with relapsing remitting‐multiple sclerosis (RRMS) in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)‐enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group. Secondary Objective: To determine or evaluate:; Safety/tolerability of LY2127399 (LY) compared to placebo.; Whether Total:; number of Gd‐enhancing MRI lesions,; number of new Gd‐enhancing MRI lesions,; number of new or newly enlarging T2‐weighted MRI lesions, and; volume of T2‐weighted MRI lesions are statistically significantly less in =1 LY group compared to placebo over the 48‐week duration of the study.; Whether the time to first relapse is statistically significantly longer in 1 or more LY groups compared to placebo.; Whether the proportion of relapse‐free subjects is greater, and whether there is a; smaller annualized relapse rate over 24 and 48 weeks in =1 LY group compared to placebo.; Proportion of subjects with anti‐LY antibodies at the end of the study.; PD of selected peripheral B cell subsets following administration of LY compared to placebo.; Serum PK of LY after multiple doses.; Effect of treatment with LY compared to placebo on EDSS, MSFC, VAS of Wellbeing, SF‐36, and QIDS‐SR16.; INCLUSION CRITERIA: 4.1. Inclusion Criteria Subjects are eligible to be included in the study only if they meet all of the following criteria: [1] Qualify as having RRMS prior to Visit 2, based on the disease diagnostic criteria as defined by revised McDonald Criteria (Polman et al. 2005). (Search revised McDonald Criteria at http://www.nationalmssociety.org). [2] A Kurtzke EDSS (Kurtzke 1983) score of 0 through 5.0. This would include subjects who are ambulatory. [3] Have at least 1 documented clinical relapse within 12 months prior to Visit 2; OR show evidence of Gd‐enhancing lesion(s) of the brain or spine by MRI performed within 12 months prior to Visit 2. [4] Are 18 to 64 years of age, inclusive. [5] Inclusion criterion [5] only applies to females of child‐bearing potential (not surgically sterilized and between menarche and 1 year postmenopause). These females must test negative for pregnancy at the time of enrollment based on a serum pregnancy test