Relapsing Multiple Sclerosis MedDRA version: 21.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: - Relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) - Expanded Disability Status Scale (EDSS) score of 0 through 5.0 - Participants with RRMS must have at least 1 of the following occurring prior to Day 1/Baseline: (a) = 2 clinical relapses in the last 24 months (but not within 30 days prior to Day 1/Baseline) with at least 1 relapse during the last 12 months prior to randomization (b) = 1 clinical relapse within the previous 2 years (but not within 30 days prior to Day 1/Baseline) and = 1 new brain MRI lesion (Gadolinium [Gd]-positive and/or new or enlarging T2 hyperintense lesion) within the previous 12 months prior to randomization (c) = 1 Gd-positive lesion on brain MRI within the previous 6 months prior to randomization Participants with SPMS must have both of the following occurring prior to Day 1/Baseline: (d) = 1 clinical relapse (but not within 30 days prior to Day 1/Baseline) and = 1 new brain MRI lesion (Gd-positive and/or new or enlarging T2 hyperintense lesion) within the previous 12 months prior to randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: - Diagnosis of primary progressive MS - Evidence of serious infection, current hepatitis C, hepatitis B infection and a history or positive test result for human immunodeficiency virus (HIV) - Has a history of systemic hypersensitivity reaction to DZP (BIIB133) or ocrelizumab - Has symptoms of bacterial, fungal, or viral infection or any opportunistic infection or any history of tuberculosis (TB) - Has a history of thromboembolic events within 12 months of Screening, or malignant disease including solid tumors and hematologic malignancies. NOTE: Other protocol defined inclusion/ exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 8 and Week 12;Main Objective: To evaluate effect of BIIB133 versus placebo on key brain magnetic resonance imaging (MRI) outcomes.;Secondary Objective: To evaluate the maintenance of effect of BIIB133 on MRI outcomes, to investigate safety and tolerability of BIIB133 in participants with RMS and to evaluate pharmacokinetics (PK) of BIIB133 and polyethylene glycol (PEG).;Primary end point(s): Number of cumulative Gd-enhancing lesions over 2 brain MRI scans at Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: Number of new or enlarging T2 hyperintense lesions from Week 4 to Week 12 Total volume of new or enlarging T2 hyperintense lesions from Week 4 to Week 12 Number of new T1 hypointense lesions from Week 4 to Week 12 Secondary endpoints: Number of new or enlarging T2 hyperintense lesions from Baseline to Week 12, from Week 12 to Week 24, and from Week 24 to Week 48 Total volume of new or enlarging T2 hyperintense from Baseline to Week 12, from Week 12 to Week 24, and from Week 24 to Week 48 Number of Gd-enhancing lesions at Weeks 12, 24, and 48 Incidence of AEs from date of first dose of DZP and incidence of SAEs from the date of signing of informed consent form Cmax and Ctrough over time;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Belgium, France, Germany, Italy, Poland, Serbia, Spain, Switzerland, United States
Outcome results
None listed