Safety Study of BIIB033 in Subjects With Multiple Sclerosis

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.