E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-Remitting Multiple Sclerosis |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to determine whether BG00012 is effective in reducing the rate of clinical relapses at 2 years. |
|
E.2.2 | Secondary objectives of the trial |
At 2 years to determine whether BG00012, when compared with placebo, is effective in: •reducing the total number of new or newly enlarging T2 hyperintense lesions on brain MRI scans in a subset of subjects; •reducing the total number of new T1 hypointense lesions on brain MRI scans in a subset of subjects; •reducing the proportion of subjects relapsed; •slowing the progression of disability as measured by at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). 2. Aged 18 to 55 years old, inclusive, at the time of informed consent. 3. Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4. 4. Must have a baseline EDSS between 0.0 and 5.0, inclusive. 5. Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of Gd-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization. 6. Male subjects and female subjects of child bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. |
|
E.4 | Principal exclusion criteria |
Medical History 1. 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. 2. Unable to perform the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, and PASAT 3. 3. Unable to perform visual function tests. 4. History of malignancy, unless an exception is granted by the Biogen Idec Medical Director. (Subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible.) 5. History of severe allergic or anaphylactic reactions or known drug hypersensitivity. 6. History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that would preclude participation in a clinical trial. 7. History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial. 8. History of human immunodeficiency virus (HIV). 9. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization. 10. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization. 11. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening. 12. Any of the following abnormal blood tests at screening: •alanine transaminase/serum glutamate-pyruvate transaminase (ALT/SGPT), or aspartate transaminase/serum glutamic-oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) ≥2 times the upper limit of normal (ULN) •leukocytes <3500/mm³ •eosinophils >0.7 x 10³/µL or >0.7 GI/L. 13. Any of the following abnormal urine tests at screening confirmed by a second urinalysis 2 weeks later: •proteinuria (1+ or greater) •hematuria, without known etiology (e.g., urinary tract infection, menses) •glycosuria, without known etiology (e.g., recent steroid use, elevated serum glucose). Treatment History 14. Any previous treatment with: •FUMADERM® or BG00012 (FAG-201) •glatiramer acetate (Copaxone®). 15. 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 TYSABRI® (natalizumab) (see exclusion #17). 16. Prior treatment with any of the following within 1 year prior to randomization: •mitoxantrone •cyclophosphamide. 17. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization: •cyclosporine •azathioprine •methotrexate •natalizumab (TYSABRI®) •intravenous immunoglobulin •plasmapheresis or cytapheresis. 18. Prior treatment with any of the following within the 3 months prior to randomization: •interferon-alpha •interferon-beta. 19. Treatment with any of the following medications within the 50 days prior to randomization: •steroids (intravenous [IV] or oral corticosteroid treatment, including agents that may act through the corticosteroid pathway [e.g., low dose naltrexone]) •4-aminopyridine or related products. 20. Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to randomization. Miscellaneous 21. Female subjects considering becoming pregnant while in the study. 22. Female subjects who are currently pregnant or breast-feeding. 23. Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to randomization. 24. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol. 25. Any other reasons that, in the opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of clinical relapses at 2 years |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Active reference comparator (open) |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Database lock - see attached justification |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 9 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 9 |