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Completed

NCT Number: NCT02525874

Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, La Louvière, Hainaut, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
  • Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011]

Key Exclusion Criteria:

  • History of or positive test result at Screening for:
  • human immunodeficiency virus
  • hepatitis C virus antibody
  • hepatitis B infection
  • Drug or alcohol abuse within 1 year prior to Screening.
  • Prior treatment with any of the following:
  • cladribine
  • mitoxantrone
  • total lymphoid irradiation
  • alemtuzumab
  • T-cell or T-cell receptor vaccination
  • any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
  • Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
  • DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
  • cyclosporine
  • azathioprine
  • methotrexate
  • mycophenolate mofetil
  • intravenous (IV) Ig
  • plasmapheresis or cytapheresis

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

dimethyl fumarate

Drug

Initial oral dose for 7 days with maintenance dose thereafter

Other names: BG00012, Tecfidera, DMF

Primary outcomes

  1. Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

    Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells.

  2. Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

    T-cells subsets includes Activated CD4+ T-cell, Activated CD8+ T-cell, Activated CD8+ T-cell [CD38+], Activated Th (T helper) 1 phenotype, Activated Th17 phenotype, Activated Th2-enriched phenotype, Activated CD4+ T-cell [CD38+HLA-DR+], Activated CD4+ T-cell [HLA-DR+], Activated CD8+ T-cell [HLA-DR+], Central Memory (CM) CD4+ T-cell [CD45RA-CCR7+], CM CD4+ T-cell [CD45RA-CCR7+], CM CD8+ T-cell [CD45RA-CCR7+], Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Effector Memory (EM) CD4+ T-cell [CD45RA-CCR7-], EM CD8+ T-cell [CD45RA-CCR7-], Effector Regulatory T-cells, Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Naïve CD4+ T-cell [CD45RA+], Naïve CD8+ T-cell [CD45RA+], Naïve (N) CD8+ T-cell [CD45RA+], Naïve Regulatory T-cells, Terminal Effector Regulatory T-cells, Th1 phenotype, Th17 phenotype, Th2-enriched phenotype. Here, Change at week is represented as CW.

  3. Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

    B-cell subsets include CD10+ Transitional B cells, CD138+ Plasma Cells, Ig (Immunoglobulin) D+ Memory B cells [non-class switched], IgD- Memory B cells [class switched], Naïve B cells, Plasma Cells [CD10-], Transitional B-cells and Plasmablasts. Here, Change at week is represented as CW.

  4. Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

    Myeloid and natural killer cell subsets include CD56Bright NK cells, CD56Dim NK cells, Classical Monocytes, Myeloid dendritic cells, Non-classical Monocytes, Plasmacytoid dendritic cells, Total dendritic cells and Total monocytes [CD14+].

  5. Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

    T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at week is represented as CW.

  6. Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

    VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells [CD11c++]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells [CD11c++]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils).

Secondary outcomes

  1. Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

  2. Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

  3. Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

  4. Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Aug 18, 2015
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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