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Safety Study of BIIB033 in Subjects With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01244139
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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.

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).


Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis Drug: BIIB033 Drug: Placebo Phase 1

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Active study drug
Treatment
 Drug: BIIB033
IV infusion of 0.3, 1, 3, 10, 30, 60 or 100 mg/kg
Experimental: Comparator
Dummy drug
 Drug: Placebo
IV infusion dummy drug


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate safety and tolerability profile of two IV infusions of BIIB033 in subjects with MS [ Time Frame: For duration of study / 6 months ]
  2. Identify incidence and types of adverse events [ Time Frame: For duration of study / 6 months ]
  3. The incidence of serious adverse events [ Time Frame: For duration of study / 6 months ]
  4. Changes from baseline in clinical lab assessments and vital signs [ Time Frame: For duration of study / 6 months ]
  5. Changes form baseline in other safety measures: physical and neurological examinations, brain MRIs, and ECGs [ Time Frame: For duration of study / 6 months ]

Secondary Outcome Measures :
  1. Assess the repeat-dose serum PK profile of BIIB033 [ Time Frame: For duration of study / 6 months ]
  2. Assess the repeat-dose immunogenicity of BIIB033 [ Time Frame: For duration of study / 6 months ]
  3. Measure the concentration of BIIB033 in the cerebrospinal fluid [ Time Frame: At specified timepoints in the study ]
  4. Explore potential biomarkers of BIIB033 activity in the periphery and in the central nervous system [ Time Frame: At specified timepoints in the study ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244139


Locations
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United States, Colorado
Research Site
Centennial, Colorado, United States
Sponsors and Collaborators
Biogen
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01244139    
Other Study ID Numbers: 215MS101
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Keywords provided by Biogen:
BIIB033
Multiple Sclerosis
anti-LINGO-1 antibody
Relapsing Remitting MS
 remyelination
myelin repair
Multiple ascending dose
Secondary progessive MS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases