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NCT03958877Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
152 (actual)
First submitted
20 May 2019
Start date
18 Oct 2019
Primary completion date
20 May 2027
Lead sponsor
Biogen
NCT number
NCT03958877
EU CT number
2023-505624-56-00
EudraCT number
2018-003008-38

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 152
  • From 18 Oct 2019 to the primary completion date, 20 May 2027
  • 60 sites in 22 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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:

Other illness

  • 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.

Lab values

  • 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.

Other

  • Part 1:
  • The participant could not tolerate BIIB017 in Part 1.
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • Part 1:
  • 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.

Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Italiano de Buenos Aires
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
Royal Children's Hospital
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ParkvilleAustraliaUnknown status
Universitair Ziekenhuis Ghent
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GhentBelgiumUnknown status
Clinique CHC MontLégia
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LiègeBelgiumUnknown status
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
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SofiaBulgariaCompleted
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaCompleted
Charité Campus Virchow-Klinikum
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BerlinGermanyUnknown status
St. Josef-Hospital Universitaetsklinikum
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BochumGermanyUnknown status
Universitaetsklinikum Freiburg
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Freiburg im BreisgauGermanyUnknown status
Universitaetsmedizin Goettingen
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GöttingenGermanyUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital Universitario Virgen de la Arrixaca
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El PalmarSpainUnknown status
Hospital Sant Joan De Deu
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Esplugues de LlobregatSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hopital Bicetre
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Le Kremlin-BicêtreFranceUnknown status
Hopital Roger Salengro, CHU Lille
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LilleFranceUnknown status
Hôpital Gui de Chauliac
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MontpellierFranceUnknown status
CHU Strasbourg - Hôpital Hautepierre
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StrasbourgFranceUnknown status
Hopital Purpan
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ToulouseFranceUnknown status
General Hospital of Larissa
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LarissaGreeceUnknown status
General Hospital of Thessaloniki 'Hippokration'
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ThessalonikiGreeceUnknown status
KBC Zagreb
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Grad ZagrebCroatiaCompleted
Semmelweis Egyetem, Gyermekgyógyászati Klinika
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BudapestHungaryActive, not recruiting
Hadassah University Hospital - Ein Kerem
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JerusalemIsraelUnknown status
Schneider Children's Medical Center
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Petach-TikvaIsraelUnknown status
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
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FlorenceItalyUnknown status
Azienda Ospedaliera Universitaria Federico II
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NaplesItalyUnknown status
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyUnknown status
Ibn Sina Hospital
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Ash ShuwaykhKuwaitUnknown status
Hospital de Braga
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BragaPortugalUnknown status
Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico
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CoimbraPortugalUnknown status
Centro Hospitalar e Universitário Lisboa Norte E.P.E.
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LisbonPortugalUnknown status
Hospital Beatriz Ângelo
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LouresPortugalUnknown status
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
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PortoPortugalUnknown status
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
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BelgradeSerbiaUnknown status
University Children Hospital
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BelgradeSerbiaUnknown status
Clinic of Neurology and Psychiatry for Children and Youth
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BelgradeSerbiaUnknown status
RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'
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BelgorodRussiaUnknown status
SAIH "Kemerovo Regional Clinical Hospital"
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KemerovoRussiaUnknown status
FSBI "Federal Siberian Scientific-Clinical Center of FMBA"
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KrasnoyarskRussiaUnknown status
SBIH of Moscow region "Moscow Regional Scientific & Research
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MoscowRussiaUnknown status
SBHI
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MoscowRussiaUnknown status
SBEI HPE 'Rostov State Medical University' of the MoH of the RF
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Rostov-on-DonRussiaUnknown status
LLC National center for socially significan disease
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Saint PetersburgRussiaUnknown status
Nebbiolo LLC
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TomskRussiaUnknown status
SBEI HPE 'Bashkir State Medical University' of the MoH of the RF
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UfaRussiaUnknown status
State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'
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YaroslavlRussiaUnknown status
King Faisal Specialist Hospital & Research Center
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JeddahSaudi ArabiaUnknown status
King Saud University
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RiyadhSaudi ArabiaUnknown status
Narodny ustav detskych chorob
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BratislavaSlovakiaCompleted
Hopital Razi
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ManoubaTunisiaUnknown status
Hôpital Fattouma Bourghiba
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MonastirTunisiaUnknown status
Hôpital Habib Bourguiba
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SfaxTunisiaUnknown status
UNC Hospitals
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Chapel HillUnited StatesUnknown status
UC San Diego Health
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La JollaUnited StatesUnknown status
Meridian Clinical Research
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NorfolkUnited StatesUnknown status
Gazi University Medical Faculty Clinical Research Unit
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AnkaraTurkey (Türkiye)Unknown status
Akdeniz University Medical Faculty
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AntalyaTurkey (Türkiye)Unknown status
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
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IzmirTurkey (Türkiye)Unknown status
Ondokuz Mayis Univ. Med. Fac.
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SamsunTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.