Phase 3 Efficacy and Safety Study of BG00012 in Pediatric 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-DE
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-03
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• 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 or anaphylactic reactions, or known drug hypersensitivity to DMF, 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.

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

NOTE: Other protocol defined exclusion criteria may apply

Study & Design

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