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A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis
Sponsor: Biogen
Summary
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.
Official title: An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension
Key Details
Gender
All
Age Range
10 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2019-10-18
Completion Date
2027-05-20
Last Updated
2025-09-11
Healthy Volunteers
No
Conditions
Interventions
BIIB017 (peginterferon beta-1a)
Administered as specified in the treatment arm
Interferon beta type 1a
Administered as specified in the treatment arm
Locations (65)
UC San Diego Health
La Jolla, California, United States
UNC Hospitals
Chapel Hill, North Carolina, United States
Meridian Clinical Research
Norfolk, Virginia, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Royal Children's Hospital
Parkville, Victoria, Australia
Universitair Ziekenhuis Ghent
Ghent, East Flanders, Belgium
Clinique CHC MontLégia
Liège, Wallonia, Belgium
MHATNP 'Sv.Naum', EAD
Sofia, Bulgaria
University Hospital Centre Split
Split, Dalmatia, Croatia
Children's Hospital Zagreb
Zagreb, Croatia
Clinical Hospital Center 'Sestre Milosrdnice'
Zagreb, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, Bas Rhin, France
Hopital Purpan
Toulouse, Haute Garonne, France
Hopital Gui de Chauliac
Montpellier, Herault, France
Hopital Roger Salengro - CHU Lille
Lille, Nord, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, Germany
St. Josef-Hospital Universitaetsklinikum
Bochum, North Rhine-Westphalia, Germany
Charité - Campus Virchow-Klinikum
Berlin, Germany
General Hospital of Larissa
Larissa, Thessaly, Greece
General Hospital of Thessaloniki 'Hippokration'
Thessaloniki, Greece
Pecsi Tudomanyegyetem KK
Pécs, Baranya, Hungary
Debreceni Egyetem
Debrecen, Hajdú-Bihar, Hungary
Semmelweis Egyetem
Budapest, Hungary
Hadassah University Hospital - Ein Kerem
Jerusalem, Levant, Israel
Schneider Children's Medical Center
Petach-Tikva, Tel Aviv, Israel
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, Italy
Azienda Ospedaliera Universitaria 'Federico II'
Naples, Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Italy
Ibn Sina Hospital
Ash Shuwaykh, Shuwaikh, Kuwait
Centro Hospitalar e Universitário Lisboa Norte E.P.E.
Lisbon, Lisbon District, Portugal
Hospital Beatriz Ângelo
Loures, Lisbon District, Portugal
Hospital de Braga
Braga, Minho, Portugal
Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico
Coimbra, Portugal
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
Porto, Portugal
SBEI HPE 'Bashkir State Medical University' of the MoH of the RF
Ufa, Bashkortostan Republic, Russia
FSBI "Federal Siberian Scientific-Clinical Center of FMBA"
Krasnoyarsk, Krasnoyarsk Krai, Russia
Nebbiolo LLC
Tomsk, Oblast, Russia
LLC National center for socially significan disease
Saint Petersburg, Sankt-Peterburg, Russia
SAIH 'Kemerovo Regional Clinical Hospital'
Kemerovo, Siberia, Russia
RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'
Belgorod, Russia
SBHI
Moscow, Russia
SBIH of Moscow region "Moscow Regional Scientific & Research
Moscow, Russia
SBEI HPE 'Rostov State Medical University' of the MoH of the RF
Rostov-on-Don, Russia
State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'
Yaroslavl, Russia
King Faisal Specialist Hospital & Research Center
Jeddah, Mecca Region, Saudi Arabia
King Saud University
Riyadh, Saudi Arabia
Clinic of Neurology and Psychiatry for Children and Youth
Belgrade, Balkans, Serbia
University Children Hospital
Belgrade, Balkans, Serbia
Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic''
Belgrade, Balkans, Serbia
Narodny ustav detskych chorob
Bratislava, Slovakia
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hopital Razi
Manouba, Mannouba, Tunisia
Hôpital Fattouma Bourghiba
Monastir, Tunisia
Hôpital Habib Bourguiba
Sfax, Tunisia
Gazi University Medical Faculty Clinical Research Unit
Ankara, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, Turkey (Türkiye)
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.
Samsun, Turkey (Türkiye)