Safety Study of BIIB033 in Subjects With Multiple Sclerosis
| Status: | Archived |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2010 |
| End Date: | June 2012 |
A Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics 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).
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.
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