Safety Study of BIIB033 in Subjects With Multiple Sclerosis

NCT01244139 | Completed Phase 1 DMC

• 1 other identifier: 215MS101
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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).

Conditions

Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Keywords

BIIB033; Multiple Sclerosis; anti-LINGO-1 antibody; Relapsing Remitting MS; remyelination; myelin repair; Multiple ascending dose; Secondary progessive MS

Outcome Measures

Primary Outcomes (5)

• Evaluate safety and tolerability profile of two IV infusions of BIIB033 in subjects with MS

  For duration of study / 6 months

• Identify incidence and types of adverse events

  For duration of study / 6 months

• The incidence of serious adverse events

  For duration of study / 6 months

• Changes from baseline in clinical lab assessments and vital signs

  For duration of study / 6 months

• Changes form baseline in other safety measures: physical and neurological examinations, brain MRIs, and ECGs

  For duration of study / 6 months

Secondary Outcomes (4)

• Assess the repeat-dose serum PK profile of BIIB033

  For duration of study / 6 months

• Assess the repeat-dose immunogenicity of BIIB033

  For duration of study / 6 months

• Measure the concentration of BIIB033 in the cerebrospinal fluid

  At specified timepoints in the study

• Explore potential biomarkers of BIIB033 activity in the periphery and in the central nervous system

  At specified timepoints in the study

Study Arms (2)

Active study drug

EXPERIMENTAL

Treatment

Drug: BIIB033

Comparator

EXPERIMENTAL

Dummy drug

Drug: Placebo

Interventions

BIIB033 DRUG

IV infusion of 0.3, 1, 3, 10, 30, 60 or 100 mg/kg

Active study drug

Placebo DRUG

IV infusion dummy drug

Comparator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Centennial, Colorado, United States

Location

Related Publications (2)

• 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.

  PMID: 25340070 BACKGROUND

• 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.

  PMID: 23595275 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

opicinumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (1)