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

• Register: EUCTR
• Last refreshed on: 11 June 2018
• Main ID: EUCTR2015-001973-42-BE
• Date of registration: 23/11/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• 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: 17/12/2015
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001973-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Kuwait, Lithuania, Poland, Turkey, United States

Contacts

• Name: N/a
• Affiliation: Biogen Idec Research Limited

• Name: N/a
• Affiliation: Biogen Idec Research Limited

Key inclusion & exclusion criteria

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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing Remitting Multiple Sclerosis
MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Dimethyl Fumarate
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: Dimethyl Fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Secondary Objective: A secondary objective is to evaluate the pharmacodynamic effect of BG00012 on absolute lymphocyte counts (ALCs) and Igs during the first year of treatment.

Timepoint(s) of evaluation of this end point: At screening, Day 1, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Main Objective: 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 RRMS.

Primary end point(s): The primary endpoint is the change in lymphocyte subset counts for up to 48 weeks.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At screening, Day 1, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Secondary end point(s): The secondary endpoints are the changes in IgG isotypes and ALCs for up to 48 weeks.

Secondary ID(s)

109MS310

Source(s) of Monetary Support

Biogen Idec Research Limited