Trial record 8 of 21 for:    Tysabri | Open Studies

BG00002 Study in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) (Tysabri Japan)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Biogen Idec.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01440101
First received: April 14, 2011
Last updated: June 7, 2012
Last verified: September 2011
  Purpose

This Phase 2 study is designed to provide data in Japanese subjects that is required for registration of BG00002 in Japan.

This study aims to confirm the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of BG00002 in Japanese patients with relapsing-remitting MS.


Condition Intervention Phase
Multiple Sclerosis
Biological: BG00002
Biological: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety,Tolerability, Pharmacokinetics , and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Measurement of new active lesions on cranial MRI scans [ Time Frame: Measured up to Week 32 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of clinical exacerbations as a measure of MS status [ Time Frame: Measured up to Week 32 ] [ Designated as safety issue: Yes ]
  • Number of lesions on MRI as a measure of MS status [ Time Frame: Measured up to Week 32 ] [ Designated as safety issue: Yes ]
  • Number of relapses as a measure of MS status [ Time Frame: Measured up to Week 32 ] [ Designated as safety issue: Yes ]
  • Changes in patient assessed outcomes [ Time Frame: Measured at Baseline, Week 12, Week 24 and Week 32 ] [ Designated as safety issue: No ]
  • Concentration of BG0002 in serum [ Time Frame: Measured up to Week 32 ] [ Designated as safety issue: No ]
  • Incidence of serum antibodies to BG00002 [ Time Frame: Measured up to Week 32 ] [ Designated as safety issue: Yes ]
  • Degree of receptor saturation by BG0002 [ Time Frame: Measured up to Week 32 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00002
300 mg IV infusions of BG00002 over 60 minutes every 4 weeks
Biological: BG00002
recombinant humanized anti-alpha4 integrin antibody
Placebo Comparator: Placebo
300 mg IV infusions of placebo over 60 minutes every 4 weeks
Biological: Placebo
Sodium phosphate, sodium chloride and polysorbate 80

Detailed Description:

This multicenter study will be comprised of 2 parts.

Part A will consist of an open-label cohort of 12 subjects. These subjects will receive 300 mg BG00002 intravenous (IV) every 4 weeks over a 6-month treatment period.

The safety, tolerability, PK, and PD profile of BG00002 will be analyzed within this group.

Part B will consist of a double-blind, placebo-controlled cohort of approximately 90 subjects randomized in a ratio of 1:1 to receive intravenous (IV) infusions of placebo or BG00002 300 mg every 4 weeks over a 6 month period. In addition to the analysis of safety, tolerability, and PK, this cohort will also provide for the efficacy assessment of BG00002

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Part A

Inclusion Criteria:

  • Must give written informed consent and any authorisations required by local law.
  • Must have a diagnosis of a relapsing-remitting MS, as defined by the revised McDonald criteria 1 through 4 (Polman et al, 2005). All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the Investigator.
  • Japanese men and women aged 18 to 65, inclusive, at the time of informed consent.
  • All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be able to continue contraception for 12 weeks after their last dose of study treatment.
  • Must have an EDSS score between 0.0 and 6.0, inclusive.
  • Must have experienced at least 1 medically documented clinical exacerbation within 12 months of Enrolment.
  • Must be willing to remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFNβ and chronic systemic corticosteroids) for the duration of the study.
  • Prior to Enrolment all subjects must have a baseline MRI, conducted within 35 calendar days prior to Enrolment.

Exclusion Criteria:

  • Diagnosis or history of neuromyelitis optica (NMO), e.g., a long spinal lesion extending over 3 or more vertebral bodies was detected, or the subject has a history of positive tests for anti-AQP4 antibodies.
  • The subject is considered by the Investigator to be immunocompromised, based on medical history, physical examination, laboratory testing, or prior immunosuppressive or immunomodulating treatment.
  • An MS exacerbation (relapse) within 30 days prior to Enrolment or, in the opinion of the Investigator, the subject has not stabilised from a relapse prior to Enrolment at Week 0.
  • History of malignancy.
  • Known history of, or positive test result for human immunodeficiency virus (HIV) infection.
  • Known history of or positive test result for Hepatitis C virus or Hepatitis B virus within the year prior to Enrolment.
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
  • A clinically significant infectious illness within 30 days prior to Enrolment.
  • Abnormal Screening liver function test results: alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >2 times of the upper limit of normal (ULN) or bilirubin >1.5 times of the ULN during Screening.
  • Previous treatment with BG0002, any murine protein, or any other therapeutic monoclonal antibody.
  • Any prior treatment with any of the following medications: total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination.
  • Treatment with immunosuppressant medications, e.g., azathioprine, cyclophosphamide, methotrexate, and FTY720 within 6 months prior to Enrolment, or mitoxantrone and cyclosporine within 12 months prior to Enrolment.
  • Treatment with any of the following medications or procedures within 6 months prior to Enrolment: intravenous immunoglobulin (IVIg), plasmapheresis, or cytapheresis.
  • Treatment with immunomodulatory medications (including IFNβ and GA) within 2 weeks of Enrolment.
  • Treatment with any of the following medications within 30 days of Enrolment: intravenous corticosteroid treatment, systemic corticosteroid treatment, 4-aminopyradine or related products.
  • Participation in any other investigational treatment within the 6 months prior to Enrolment or concurrent with this study.

Part B

Inclusion Criteria:

  • Must give written informed consent and any authorisations required by local law.
  • Must have a diagnosis of a relapsing-remitting MS, as defined by the revised McDonald criteria 1 through 4 (Polman et al, 2005). All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the Investigator.
  • Japanese men and women aged 18 to 65, inclusive, at the time of informed consent.
  • All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be able to continue contraception for 12 weeks after their last dose of study treatment.
  • Must have an EDSS score between 0.0 and 5.5, inclusive.
  • Must have experienced at least 1 medically documented clinical exacerbation within 12 months of Enrolment.
  • Must be willing to remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFNβ and chronic systemic corticosteroids) for the duration of the study.
  • Prior to Enrolment all subjects must have: a screening MRI, or documentation of an MRI within the subject's medical record within 1 year of the screening visit, which reveals 3 or more T2 hyperintense lesions consistent with MS, and a baseline MRI, conducted within 7 calendar days prior to Enrolment, which reveals at least 1 MRI lesion consistent with MS.

Exclusion Criteria

  • Diagnosis or history of neuromyelitis optica (NMO), e.g., a long spinal lesion extending over 3 or more vertebral bodies was detected, or the subject has a history of positive tests for anti-AQP4 antibodies.
  • The subject is considered by the Investigator to be immunocompromised, based on medical history, physical examination, laboratory testing, or prior immunosuppressive or immunomodulating treatment.
  • An MS exacerbation (relapse) within 30 days prior to Enrolment or, in the opinion of the Investigator, the subject has not stabilised from a relapse prior to Enrolment at Week 0.
  • History of malignancy.
  • Known history, or positive test result of HIV infection.
  • Known history of or positive test result for Hepatitis C virus or Hepatitis B virus within the year prior to Enrolment.
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
  • A clinically significant infectious illness within 30 days prior to Enrolment.
  • Abnormal Screening liver function test results: ALT or AST >2 times of the ULN or bilirubin >1.5 times of the ULN during Screening.
  • Previous treatment with BG0002, any murine protein, or any other therapeutic monoclonal antibody.
  • Any prior treatment with any of the following medications: total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination.
  • Treatment with immunosuppressant medications, e.g., azathioprine, cyclophosphamide, methotrexate, and FTY720 within 6 months prior to Enrolment, or mitoxantrone and cyclosporine within 12 months prior to Enrolment.
  • Treatment with any of the following medications or procedures within 6 months prior to Enrolment: IVIg, plasmapheresis, or cytapheresis.
  • Treatment with immunomodulatory medications (including IFNβ and GA) within 2 weeks of Enrolment.
  • Treatment with any of the following medications within 30 days of Enrolment: intravenous corticosteroid treatment, systemic corticosteroid treatment, 4-aminopyradine or related products.
  • Participation in any other investigational treatment within the 6 months prior to Enrolment or concurrent with this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440101

Contacts
Contact: Biogen Idec MD, MS neurologyclinicaltrials@biogenidec.com

Locations
Japan
Research Site Recruiting
Chiba,, Japan
Research Site Recruiting
Fukuoka,, Japan
Research Site Recruiting
Hiroshima,, Japan
Research Site Recruiting
Kawagoe,, Japan
University of British Columbia Recruiting
Kodaira,, Japan
London Health Sciences Centre Recruiting
Kyoto,, Japan
Research Site Recruiting
Kyoto,, Japan
Research Site Recruiting
Morioka,, Japan
Research Site Recruiting
Niigata,, Japan
Research Site Recruiting
Osaka,, Japan
Univ of Calgary / Foothills MC Recruiting
Osaka,, Japan
Research Site Recruiting
Sapporo,, Japan
Research Site Recruiting
Sendai,, Japan
Research Site Recruiting
Suita,, Japan
Research Site Recruiting
Tokorozawa,, Japan
Research Site Recruiting
Tokyo,, Japan
Research Site Recruiting
Tsukuba,, Japan
Research Site Recruiting
Ube,, Japan
Research Site Recruiting
Yokohama,, Japan
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Ltd
ClinicalTrials.gov Identifier: NCT01440101     History of Changes
Other Study ID Numbers: 101MS203
Study First Received: April 14, 2011
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

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

ClinicalTrials.gov processed this record on April 16, 2014