Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, MRI
Brief summary
Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
Detailed description
The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.
Interventions
DRUGBG00012
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Must be 18 to 55 years old, inclusive, at the time of informed consent. 2. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2). 3. Must have a baseline EDSS between 0.0 and 5.0, inclusive. 4. Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks. 5. Male and female subjects must be willing to take appropriate measures to prevent pregnancy.
Exclusion criteria
1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 \[Appendix 3\]). 2. History of malignancy. 3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity. 4. History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease. 5. History of human immunodeficiency virus (HIV). 6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization. 7. 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. 8. Body weight \>100 kg. 9. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening. 10. Any of the following abnormal blood tests at screening. 11. Any previous treatment with FUMADERM®, FAG-201, or BG00012. 12. A medication history that precludes entry into the study. 13. Female subjects who are currently pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. | Weeks 12, 16, 20, and 24 |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will include measuring the changes in MRIs from baseline until Week 24, changes in other MS measurements q12 weeks, and the annualized relapse rate and proportion of changes at Weeks 24 and 48. | Weeks 24 and 48 |
Countries
Czechia, Germany, Hungary, Netherlands, Poland, Russia, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Outcome results
None listed