Safety Study of BIIB033 in Subjects With Multiple Sclerosis
A Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Opicinumab
Leucine-rich repeat and immunoglobulin-like domain-containing nogo receptor-interacting protein 1 inhibitor
Placebo
- Placebo
What it measured
Main measures
Evaluate safety and tolerability profile of two IV infusions of BIIB033 in subjects with MS
For duration of study / 6 months
SafetyIdentify incidence and types of adverse events
For duration of study / 6 months
SafetyThe incidence of serious adverse events
For duration of study / 6 months
SafetyChanges from baseline in clinical lab assessments and vital signs
For duration of study / 6 months
SafetyChanges form baseline in other safety measures: physical and neurological examinations, brain MRIs, and ECGs
For duration of study / 6 months
Safety
Other measures (4)
Assess the repeat-dose serum PK profile of BIIB033
For duration of study / 6 months
How the body handles the medicineAssess the repeat-dose immunogenicity of BIIB033
For duration of study / 6 months
Immune responseMeasure the concentration of BIIB033 in the cerebrospinal fluid
At specified timepoints in the study
Blood or spinal fluid markersExplore potential biomarkers of BIIB033 activity in the periphery and in the central nervous system
At specified timepoints in the study
Blood or spinal fluid markers
Who could take part
Relapsing and progressive · 18 to 60 · EDSS 1 to 6
Show the full 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Results
Boyd A, Zhang H, Williams A. Insufficient OPC migration into demyelinated lesions is a cause of poor remyelination in MS and mouse models. Acta Neuropathol. 2013 Jun;125(6):841-59. doi: 10.1007/s00401-013-1112-y. Epub 2013 Apr 18.Background
Tran JQ, Rana J, Barkhof F, Melamed I, Gevorkyan H, Wattjes MP, de Jong R, Brosofsky K, Ray S, Xu L, Zhao J, Parr E, Cadavid D. Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033. Neurol Neuroimmunol Neuroinflamm. 2014 Aug 21;1(2):e18. doi: 10.1212/NXI.0000000000000018. eCollection 2014 Aug.
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History
Started
Oct 2010
Main results due
Apr 2012
Finished
Apr 2012