Efficacy and Safety of BG00012 in MS

August 24, 2023 updated by: Biogen

Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Determine the efficacy, safety, and tolerability of BG00012 in MS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Bmo, Czechia, 656 91
        • Faculty Hospital St. Anne
      • Hradec Kralove, Czechia, 500 05
        • Faculty Hospital
      • Pardupice, Czechia, 532 03
        • Hospital of Pardubice
      • Plzen, Czechia, 304 60
        • Faculty Hospital of Plzen
      • Prague, Czechia, 128 02
        • General Teaching Hospital
  • Germany
      • Bochum, Germany, 44791
        • Bochum am St. Josef-Hospital
      • Dusseldorf, Germany, 40225
        • Heinrich-Heine-Universität
      • Goettigen, Germany, 37073
        • George-August-Universitat Goettigen
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Hospital
      • Debrecen, Hungary, 4012
        • University of Debrecen
      • Gyor, Hungary, 9024
        • Petz Aladar County Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VUMC
      • Rotterdam, Netherlands, 3015 GD
        • Academic Hospital Rotterdam
  • Poland
      • Bialystok, Poland, 15-276
        • SamodzielnyPubliczny Szpital Kliniczny
      • Bialystok, Poland, 15-420
        • Niesalezny Zespol Opieki Zdrowognej
      • Bydgoszcz, Poland, 85-681
        • 10 Wojskowy Szpital Kliniczny z Polikliniką
      • Gdansk, Poland, 80-803
        • Wojewodzki Szpital Specjalistczny
      • Katowice-Ligota, Poland, 41-741
        • Slaskiej Akademii Medycznej
      • Krakow, Poland, 31-503
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Poland, 90-153
        • Panstwowy Szpital Kliniczny
      • Warszawa, Poland, 01-097
        • Samodzielny Publiczny Centralny Szpital
  • Russian Federation
      • Moscow, Russian Federation, 123182
      • Moscow, Russian Federation, 123367
      • Moscow, Russian Federation, 1153682
      • Moscow, Russian Federation, 127018
      • Novgorod, Russian Federation, 603076
      • Novosibirsk, Russian Federation, 630075
      • St. Petersburg, Russian Federation, 197022
      • St. Petersburg, Russian Federation, 194044
      • St. Petersburg, Russian Federation, 194291
      • St. Petersburg, Russian Federation, 197376
  • Sweden
      • Molndal, Sweden, 431 80
        • MS Centrum
      • Stockholm, Sweden, 141 86
        • Karolinska University Hospital
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital
  • Switzerland
      • Basel, Switzerland, CH 4.31
        • Kantonsspital Basel
  • Turkey
      • Ankara, Turkey, 6100
        • Hacettepe Unisersitesi
      • Istanbul, Turkey, 34303
        • Istanbul University
      • Istanbul, Turkey, TR-34390
        • University of Instanbul
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Multiple Sclerosis Reseach Clinic
      • London, United Kingdom, WC1N 3BG
        • Institute of Neurology
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hampshire Hospital
      • Stoke-on-Trent, United Kingdom, ST4 7LN
        • University Hospital of North Staffordshire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.
Time Frame: Weeks 12, 16, 20, and 24
Weeks 12, 16, 20, and 24

Secondary Outcome Measures

Outcome 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.
Time Frame: Weeks 24 and 48
Weeks 24 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Principal Investigator: Ludwig Kappos, Prof, Kantonsspital Basel
  • Study Director: Gilmore O'Neill, MB,MRCPI,MMedSc, Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2004

Primary Completion (Actual)

March 31, 2006

Study Completion (Actual)

March 31, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimated)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1900

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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