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NCT02283853

PHASE3

Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Sponsor: Biogen

View on ClinicalTrials.gov

Summary

The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in participants who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in participants who completed Week 96 in Part 1 of Study 109MS306.

Official title: Open-Label, Randomized, Multicenter, Multiple-Dose, Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2014-08-28

Completion Date

2025-07-08

Last Updated

2026-05-19

Healthy Volunteers

Conditions

Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

dimethyl fumarate

administered orally

DRUG

Interferon β-1a

administered by intramuscular injection

Key Inclusion Criteria: * Males and females aged from 10 to less than 18 years old at the time of informed consent or assent. * 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 of the following 3 conditions: a) at least 1 relapse within the last 12 months prior to Day 1 with a prior brain MRI demonstrating lesions consistent with MS; b) at least 2 relapses within the last 24 months prior to Day 1, with a prior brain MRI demonstrating lesions consistent with MS; c) 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. * Participants 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. 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. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting participants 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. Participants 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 beta-1a (IFN Beta-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 participant 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 participant unsuitable for enrollment. NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Locations (62)

Boston Children's Hospital

Boston, Massachusetts, United States

The Rector and Visitors of the University of Virginia

Charlottesville, Virginia, United States

Universitair Kinderziekenhuis Koningin Fabiola

Brussels, Belgium

Universitair Ziekenhuis Ghent

Ghent, Belgium

MHATNP 'Sv.Naum', EAD

Sofia, Bulgaria

University of Calgary - Alberta Children's Hospital

Calgary, Alberta, Canada

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Nemocnice Jihlava p.o.

Jihlava, Czechia

Fakultni nemocnice Ostrava

Ostrava, Czechia

Århus Universitetshospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense Universitetshospital

Odense, Denmark

CHU Strasbourg - Hôpital Hautepierre

Strasbourg, Bas Rhin, France

Hôpital de la Timone

Marseille, Bouches-du-Rhône, France

CHU Dijon -BOCAGE CENTRAL

Dijon, Côte-d'Or, France

Hopital Gui de Chauliac

Montpellier, Herault, France

CHU Rennes - Hopital Pontchaillou

Rennes, Ille Et Vilaine, France

Hôpital de Brabois Enfants

Vandœuvre-lès-Nancy, Meurthe Et Moselle, France

Hopital Roger Salengro - CHU Lille

Lille, Nord, France

CHU Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, Puy De Dome, France

Hopital Neurologique Pierre Wertheimer

Bron, Rhone, France

CHU Amiens - Hopital Sud

Amiens, Somme, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, Val De Marne, France

Universitaetsklinikum Augsburg

Augsburg, Bavaria, Germany

Klinikum der Universitaet Muenchen

Munich, Bavaria, Germany

Katholisches Klinikum Bochum gGmbH

Bochum, North Rhine-Westphalia, Germany

Semmelweis Egyetem

Budapest, Hungary

Heim Pal Orszagos Gyermekgyogyaszati Intezet

Budapest, Hungary

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel

Schneider Children's Medical Center

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)

Gallarate, Varese, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliera Universitaria 'Federico II'

Naples, Italy

Azienda Ospedale-Università di Padova

Padova, Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

Roma, Italy

Ibn Sina Hospital

Ash Shuwaykh, Kuwait

SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu

Poznan, Poland

Instytut 'Pomnik - Centrum Zdrowia Dziecka'

Warsaw, Poland

Clinic of Neurology and Psychiatry for Children and Youth

Belgrade, Serbia

Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic''

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Córdoba, Spain

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Sahlgrenska Sjukhuset

Gothenburg, Sweden

Karolinska

Stockholm, Sweden

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Akdeniz University Faculty of Medicine

Antalya, Turkey (Türkiye)

Evelina London Children's Hospital

London, Greater London, United Kingdom

The National Hospital for Neurology & Neurosurgery

London, Greater London, United Kingdom

Great Ormond Street Hospital for Children

London, Greater London, United Kingdom

Birmingham Children's Hospital

Birmingham, West Midlands, United Kingdom

Clinical Research Directory

Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (62)