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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02525874
• Date of registration: 10/07/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
• Scientific title: An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis
• Date of first enrolment: August 11, 2015
• Target sample size: 218
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02525874
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Bulgaria, Croatia, Kuwait, Lithuania, Poland, Turkey, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: dimethyl fumarate

Primary Outcome(s)

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]

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]

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]

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]

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]

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]

Secondary Outcome(s)

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]

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]

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]

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]

Secondary ID(s)

109MS310

2015-001973-42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02525874