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
NCT ID: NCT03958877
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
152 participants
INTERVENTIONAL
2019-10-18
2027-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIIB017 (peginterferon beta-1a)
Participants will receive subcutaneous (SC) injection of BIIB017 (peginterferon beta-1a) 63 microgram (μg) on Day 1, followed by 94 μg at Week 2, followed by 125 μg at Week 4, and then 125 μg SC injection every 2 weeks up to Week 96 in Part 1 of the study. Eligible participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.
BIIB017 (peginterferon beta-1a)
Administered as specified in the treatment arm
Avonex
Participants will receive Avonex (interferon beta type 1a) starting at a dose of 7.5 μg on Day 1, followed by an increase of 7.5 μg each week for 3 weeks, followed by 30 μg intramuscular (IM) injections every week up to Week 96 in Part 1 of the study. Eligible participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.
Interferon beta type 1a
Administered as specified in the treatment arm
Interventions
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BIIB017 (peginterferon beta-1a)
Administered as specified in the treatment arm
Interferon beta type 1a
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS.
* Must have an EDSS score between 0.0 and 5.5.
* Must have experienced \>= 1 relapse in the 12 months prior to randomization (Day 1) or \>= 2 relapses in the 24 months prior to randomization (Day 1) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1).
Part 2:
• Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.
Exclusion Criteria
* Primary progressive, secondary progressive, or progressive relapsing MS. 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 participants by the lack of clinically stable periods or clinical improvement.
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
* Known allergy to any component of Avonex or BIIB017 formulation.
* Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (Day 1).
* Any previous treatment with PEGylated human IFN β-1a.
Part 2:
* Any significant changes in medical history occurring after enrollment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the participant's participation in Part 1. The Investigator must re-assess the participant's medical fitness for participation and consider any factors that would preclude treatment.
* The participant could not tolerate BIIB017 in Part 1.
10 Years
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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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'
Napoli, , Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, , 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)
Countries
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Other Identifiers
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2018-003008-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505624-56
Identifier Type: OTHER
Identifier Source: secondary_id
105MS306
Identifier Type: -
Identifier Source: org_study_id
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