Phase 3 Efficacy and Safety Study of BG00012 in Subjects With relapsing-remitting multiple sclerosis (RRMS).

Phase 1

• Conditions: Relapsing-Remitting Multiple Sclerosis; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-002318-11-BE
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-17
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

key inclusion criteria:
- Must have a body weight of =30 kg.
- Must have a diagnosis of RRMS (consensus definition for pediatric
RRMS [Krupp 2013]).
- Must be ambulatory with a baseline EDSS score between 0 and 5.5,
inclusive.
- Must have experienced at least 1 relapse within the last 12 months
prior to Day 1, or at least 2 relapses within the last 24 months prior to
Day 1, with a prior brain MRI demonstrating lesions consistent with MS,
or evidence of Gd enhancing lesions of the brain on an MRI
performed within the 6 weeks prior to Day 1.
- Must be neurologically stable, with no evidence of relapse within 50
days prior to Day 1 and no evidence of corticosteroid treatment within
30 days prior to Day 1.
- Subjects of childbearing potential who are sexually active must be
willing to practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their final
dose of study treatment.

Part 2:
- Subjects who have completed Week 96 in Part 1

NOTE: Other Protocol defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 132
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key exclusion criteria:
- Primary progressive, secondary progressive, or progressive relapsing
MS (as defined by [Lublin and Reingold 1996]). These conditions require
the presence of continuous clinical disease worsening over a period of at
least 3 months. Subjects with these conditions may also have
superimposed relapses but are distinguished from relapsing remitting
subjects by the lack of clinically stable periods or clinical improvement.
- Disorders mimicking MS, such as other demyelinating disorders (e.g.,
acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus), metabolic disorders (e.g.,
dystrophies), and infectious disorders.
- History of premalignant or malignant disease. Subjects with basal cell
carcinoma that has been completely excised prior to screening will
remain eligible.
- History of severe allergic, anaphylactic reactions, or known drug
hypersensitivity to DMF or fumaric acid esters or interferon ß-1a (IFN ß-
1a).
- History of abnormal laboratory results indicative of any significant
endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic,
renal, and/or any other major disease that would preclude participation
in a clinical study.
- History of clinically significant cardiovascular, pulmonary, GI,
dermatologic, growth, developmental, psychiatric (including
depression), neurologic (other than MS), and/or other major disease
that would preclude participation in a clinical study.
- History of human immunodeficiency virus.
- An MS relapse that has occurred within 50 days prior to Day 1 AND/OR
the subject has not stabilized from a previous relapse prior to Day 1.
- Other unspecified reasons that, in the opinion of the Investigator or
Biogen Idec, make the subject unsuitable for enrollment.
- For the PD/PK subset of subjects: subjects unable to swallow the
BG00012 capsule whole.
Key Treatment history
- Any previous treatment with Fumaderm (fumaric acid esters) or
BG00012.
- Prior treatment with any of the following: total lymphoid irradiation,
cladribine, T-cell or T-cell receptor vaccination, any therapeutic
monoclonal antibody, with the exception of rituximab or natalizumab
- Prior treatment with any of the following medications within the 12
months prior to Day 1: mitoxantrone, cyclophosphamide, rituximab
- Prior treatment with any of the following medications or procedures
within 6 months prior to Day 1: fingolimod, teriflunomide, natalizumab,
cyclosporine, azathioprine, methotrexate, mycophenolate mofetil,
laquinimod, IV immunoglobulin, plasmapheresis or cytapheresis
- Treatment with any of the following medications within 30 days prior
to Day 1:
- steroids (IV or oral corticosteroid treatment, including agents that may
act through the corticosteroid pathway [e.g., low dose naltrexone]), 4-
aminopyridine or related products (except subjects on a stable dose of
controlled-release fampridine for 3 months)

Part 2;
- Any significant changes in medical history occurring after enrollment in
Part 1
- Subjects who could not tolerate BG00012 in Part 1
NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified