Efficacy and Safety of BG00012 in MS

Phase 2

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT00168701
• Lead Sponsor: Biogen

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.

Study Timeline

• Study Start: 2004-10-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2006-03-31
• Study Completion: 2006-03-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (31)

Faculty Hospital St. Anne; 🇨🇿 Bmo, Czechia

Faculty Hospital; 🇨🇿 Hradec Kralove, Czechia

Hospital of Pardubice; 🇨🇿 Pardupice, Czechia

Faculty Hospital of Plzen; 🇨🇿 Plzen, Czechia

General Teaching Hospital; 🇨🇿 Prague, Czechia

Bochum am St. Josef-Hospital; 🇩🇪 Bochum, Germany

Heinrich-Heine-Universitat; 🇩🇪 Dusseldorf, Germany

George-August-Universitat Goettigen; 🇩🇪 Goettigen, Germany

Uzsoki Hospital; 🇭🇺 Budapest, Hungary

University of Debrecen; 🇭🇺 Debrecen, Hungary

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