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Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS).
EU CTIS ID: 2023-505632-35-00
What this study is testing
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy on the disease course of BG00012 (dimethyl fumarate) in subjects with RRMS, as compared with a disease modifying treatment. To assess health outcomes and evolution of disability The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed week 96 in Part 1 of Study 109MS306.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- Key Treatment history - Any previous treatment with Fumaderm (fumaricacid esters) or BG00012
- Prior treatment with any of the following: total lymphoid irradiation, cladribine, Tcell or Tcell 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; intravenous (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 not act through the corticosteroid pathway [e.g.low dose naltrexone]), 4aminopyridine or related products (except subjects on a stable dose of controlled release fampridine for 3 months)
See the full eligibility criteria
Who can join
- 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 Week96 in Part 1
What rules you out
- 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.
- Key Treatment history - Any previous treatment with Fumaderm (fumaricacid esters) or BG00012
- Prior treatment with any of the following: total lymphoid irradiation, cladribine, Tcell or Tcell 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; intravenous (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 not act through the corticosteroid pathway [e.g.low dose naltrexone]), 4aminopyridine 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
- 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 or anaphylactic reactions, or known drug hypersensitivity to DMF, fumaric acid esters or interferon β-1a (IFN β1a).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Turkey
- Kuwait
- United Kingdom
- Serbia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Turkey; Kuwait; United Kingdom; Serbia; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.