Safety Study of BIIB033 in Subjects With Multiple Sclerosis
The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS.
Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101).
Relapsing-Remitting Multiple Sclerosis
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
|Official Title:||A Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Multiple Sclerosis|
- Evaluate safety and tolerability profile of two IV infusions of BIIB033 in subjects with MS [ Time Frame: For duration of study / 6 months ]
- Identify incidence and types of adverse events [ Time Frame: For duration of study / 6 months ]
- The incidence of serious adverse events [ Time Frame: For duration of study / 6 months ]
- Changes from baseline in clinical lab assessments and vital signs [ Time Frame: For duration of study / 6 months ]
- Changes form baseline in other safety measures: physical and neurological examinations, brain MRIs, and ECGs [ Time Frame: For duration of study / 6 months ]
- Assess the repeat-dose serum PK profile of BIIB033 [ Time Frame: For duration of study / 6 months ]
- Assess the repeat-dose immunogenicity of BIIB033 [ Time Frame: For duration of study / 6 months ]
- Measure the concentration of BIIB033 in the cerebrospinal fluid [ Time Frame: At specified timepoints in the study ]
- Explore potential biomarkers of BIIB033 activity in the periphery and in the central nervous system [ Time Frame: At specified timepoints in the study ]
|Study Start Date:||October 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Active study drug
IV infusion of 0.3, 1, 3, 10, 30, 60 or 100 mg/kg
IV infusion dummy drug
BIIB033 is a protein that acts on certain types of brain cells by blocking the function of another protein called LINGO-1. It is believed that LINGO-1 is one of the reasons why nerves in the brain of patients with MS do not repair well. It is thought BIIB033 may improve MS by repairing damaged nerve tissue. LINGO-1 is also present in the brain of healthy people.
Subjects will take part in the 215MS101 study for up to 28 weeks. This includes a 4-week screening period, a 2 week treatment period in which 2 doses of BIIB033 are given, and a post-dosing safety follow up period of up to 22 weeks (depending on dose cohort).
The study tests vary at each of the individual visits and may include:
medical history evaluation, height and weight assessment, physical examination, neurological examination, vital signs assessment (pulse, respiratory rate, blood pressure, and temperature), MS performance score, electrocardiogram, cardiac monitoring, routine blood and urine tests, drug concentration testing of the blood, hepatitis and HIV tests, blood clotting tests, brain MRI scan, lumbar puncture, and drugs of abuse screen and pregnancy test.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244139
|United States, Colorado|
|Centennial, Colorado, United States|