Safety Study of BIIB033 in Subjects With Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01244139
First received: November 18, 2010
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Drug: BIIB033
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

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

Secondary Outcome Measures:
  • Assess the repeat-dose serum PK profile of BIIB033 [ Time Frame: For duration of study / 6 months ] [ Designated as safety issue: Yes ]
  • Assess the repeat-dose immunogenicity of BIIB033 [ Time Frame: For duration of study / 6 months ] [ Designated as safety issue: Yes ]
  • Measure the concentration of BIIB033 in the cerebrospinal fluid [ Time Frame: At specified timepoints in the study ] [ Designated as safety issue: Yes ]
  • Explore potential biomarkers of BIIB033 activity in the periphery and in the central nervous system [ Time Frame: At specified timepoints in the study ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244139

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

No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01244139     History of Changes
Other Study ID Numbers: 215MS101
Study First Received: November 18, 2010
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
BIIB033
Multiple Sclerosis
anti-LINGO-1 antibody
Relapsing Remitting MS
remyelination
myelin repair
Multiple ascending dose
Secondary progessive MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014