Status:
COMPLETED
Safety Study of BIIB033 in Subjects With Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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. Approximat...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Give informed consnet
- Aged 18 to 60 years
- Have relapsing remitting MS or secondary progressive MS
- EDSS score of 1 to 6 inclusive
- Body mass index of 18 to 30 kg/m2
- Commitment to use effective contraception 6 months after last dose of study drug Treatment with any interferon beta or glatiramer acetate is allowed to continue during the study as long as the initiation of treatment was at least 3 months and the dose is stable.
- Key
Exclusion
- Primary progressive MS
- Any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, allergic or anaphylactic reactions or other major disease
- Clinically significant lab value at screening outside of normal range
- Clinically significant ECG abnormality
- Contraindication to MRI scans or lumbar punctures
- Plans to undergo elective surgery during study
- An MS relapse that has not resolved within 30 days before screening
- History or postive test result for Hepatitis B, C and HIV
- Serious infections within 3 months prior to Day -1
- Treatment with MS medication within 12 months prior to Day -1: natalizumab, daclizumab, azathioprine, methotrexate, iV immunoglobulin, plasmapheresis or mycophenolate motefil
- Prior treatment with total lymphoid irradiation, T cell or T-cell receptor vaccination, alemtuzumab, mitoxantone, cyclophosphamide, rituximab, fingolimod.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01244139
Start Date
October 1 2010
End Date
April 1 2012
Last Update
January 9 2017
Active Locations (1)
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1
Research Site
Centennial, Colorado, United States