Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Um estudo para avaliar a segurança, tolerabilidade e eficácia de BIIB017 (Peginterferon Beta-1a) em participantes pediátricos para o tratamento da esclerose múltipla recorrente-remitente

23 de setembro de 2026 atualizado por: Biogen

Um estudo aberto, randomizado, multicêntrico, controlado por ativos, de grupo paralelo para avaliar a segurança, tolerabilidade e eficácia do BIIB017 em pacientes pediátricos com idade entre 10 e menos de 18 anos para o tratamento de esclerose múltipla recorrente-remitente, com opção Extensão de etiqueta aberta

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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

152

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 13353
        • Charité - Campus Virchow-Klinikum
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Alemanha, 79106
        • Universitaetsklinikum Freiburg
    • Lower Saxony
      • Göttingen, Lower Saxony, Alemanha, 37075
        • Universitaetsmedizin Goettingen
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Alemanha, 44791
        • St. Josef-Hospital Universitaetsklinikum
  • Argentina
    • Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires
  • Arábia Saudita
      • Riyadh, Arábia Saudita, 11461
        • King Saud University
    • Mecca Region
      • Jeddah, Mecca Region, Arábia Saudita, 40047
        • King Faisal Specialist Hospital & Research Center
  • Austrália
    • Victoria
      • Parkville, Victoria, Austrália, 3052
        • Royal Children's Hospital
  • Bulgária
      • Sofia, Bulgária, 1113
        • MHATNP 'Sv.Naum', EAD
  • Bélgica
    • East Flanders
      • Ghent, East Flanders, Bélgica, 9000
        • Universitair Ziekenhuis Ghent
    • Wallonia
      • Liège, Wallonia, Bélgica, 4000
        • Clinique CHC MontLégia
  • Croácia
      • Zagreb, Croácia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Croácia, 10000
        • Children's Hospital Zagreb
      • Zagreb, Croácia, 10000
        • Clinical Hospital Center 'Sestre Milosrdnice'
    • Dalmatia
      • Split, Dalmatia, Croácia, 21000
        • University Hospital Centre Split
  • Eslováquia
      • Bratislava, Eslováquia, 83340
        • Narodny ustav detskych chorob
  • Espanha
      • Córdoba, Espanha, 14011
        • Hospital Universitario Reina Sofia
      • Madrid, Espanha, 28034
        • Hospital Universitario Ramon y Cajal
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Espanha, 08950
        • Hospital Sant Joan de Deu
    • Murcia
      • El Palmar, Murcia, Espanha, 30120
        • Hospital Universitario Virgen de la Arrixaca
  • Estados Unidos
    • California
      • La Jolla, California, Estados Unidos, 92024
        • UC San Diego Health
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27514
        • UNC Hospitals
    • Virginia
      • Norfolk, Virginia, Estados Unidos, 23502
        • Meridian Clinical Research
  • França
    • Bas Rhin
      • Strasbourg, Bas Rhin, França, 67098
        • CHU Strasbourg - Hôpital Hautepierre
    • Haute Garonne
      • Toulouse, Haute Garonne, França, 31059
        • Hopital Purpan
    • Herault
      • Montpellier, Herault, França, 34295
        • Hopital Gui de Chauliac
    • Nord
      • Lille, Nord, França, 59037
        • Hopital Roger Salengro - CHU Lille
    • Val De Marne
      • Le Kremlin-Bicêtre, Val De Marne, França, 94275
        • Hôpital Bicêtre
  • Grécia
      • Thessaloniki, Grécia, 54642
        • General Hospital of Thessaloniki 'Hippokration'
    • Thessaly
      • Larissa, Thessaly, Grécia, 41110
        • General Hospital of Larissa
  • Hungria
      • Budapest, Hungria, 1083
        • Semmelweis Egyetem
    • Baranya
      • Pécs, Baranya, Hungria, 7623
        • Pecsi Tudomanyegyetem KK
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungria, 4032
        • Debreceni Egyetem
  • Israel
    • Levant
      • Jerusalem, Levant, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
    • Tel Aviv
      • Petach-Tikva, Tel Aviv, Israel, 4920235
        • Schneider Children's Medical Center
  • Itália
      • Florence, Itália, 50139
        • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
      • Naples, Itália, 80131
        • Azienda Ospedaliera Universitaria 'Federico II'
      • Naples, Itália, 80138
        • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
  • Kuwait
    • Shuwaikh
      • Ash Shuwaykh, Shuwaikh, Kuwait, 12345
        • Ibn Sina Hospital
  • Portugal
      • Coimbra, Portugal, 3000-602
        • Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1649-035
        • Centro Hospitalar e Universitário Lisboa Norte E.P.E.
      • Loures, Lisbon District, Portugal, 2674-514
        • Hospital Beatriz Ângelo
    • Minho
      • Braga, Minho, Portugal, 4710-243
        • Hospital de Braga
  • Rússia
      • Belgorod, Rússia, 308007
        • RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'
      • Moscow, Rússia, 119602
        • SBHI
      • Moscow, Rússia, 129110
        • SBIH of Moscow region "Moscow Regional Scientific & Research
      • Rostov-on-Don, Rússia, 344022
        • SBEI HPE 'Rostov State Medical University' of the MoH of the RF
      • Yaroslavl, Rússia, 150000
        • State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'
    • Bashkortostan Republic
      • Ufa, Bashkortostan Republic, Rússia, 450077
        • SBEI HPE 'Bashkir State Medical University' of the MoH of the RF
    • Krasnoyarsk Krai
      • Krasnoyarsk, Krasnoyarsk Krai, Rússia, 660037
        • FSBI "Federal Siberian Scientific-Clinical Center of FMBA"
    • Oblast
      • Tomsk, Oblast, Rússia, 634009
        • Nebbiolo LLC
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rússia, 197110
        • LLC National center for socially significan disease
    • Siberia
      • Kemerovo, Siberia, Rússia, 650066
        • SAIH 'Kemerovo Regional Clinical Hospital'
  • Sérvia
    • Balkans
      • Belgrade, Balkans, Sérvia, 11000
        • Clinic of Neurology and Psychiatry for Children and Youth
      • Belgrade, Balkans, Sérvia, 11000
        • University Children Hospital
      • Belgrade, Balkans, Sérvia, 11070
        • Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic''
  • Tcheca
      • Hradec Králové, Tcheca, 50333
        • Fakultni nemocnice Hradec Kralove
  • Tunísia
      • Monastir, Tunísia, 5000
        • Hôpital Fattouma Bourghiba
      • Sfax, Tunísia, 3029
        • Hôpital Habib Bourguiba
    • Mannouba
      • Manouba, Mannouba, Tunísia, 2010
        • Hopital Razi
  • Turquia (Türkiye)
      • Ankara, Turquia (Türkiye), 06500
        • Gazi University Medical Faculty Clinical Research Unit
      • Antalya, Turquia (Türkiye), 07059
        • Akdeniz University Medical Faculty
      • Izmir, Turquia (Türkiye), 35210
        • Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
      • Samsun, Turquia (Türkiye), 55139
        • Ondokuz Mayis Univ. Med. Fac.

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

10 anos a 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

Part 1:

  • 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: BIIB017 (peginterferon beta-1a)

Administered as specified in the treatment arm

Outros nomes:
  • PLEGRIDIA
Comparador Ativo: 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.
Medicamento: Interferon beta type 1a

Administered as specified in the treatment arm

Outros nomes:
  • Avonex

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part 1: Annualized Relapse Rate (ARR) at Week 48
Prazo: Week 48

A multiple sclerosis (MS) relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. ARR is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.
Week 48
Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Treatment Discontinuation
Prazo: From Week 96 to Week 196

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
From Week 96 to Week 196

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Parte 1: Porcentagem de participantes livres de novas ou recém-ampliadas lesões hiperintensas T2 em imagens de ressonância magnética cerebral (MRI) nas semanas 24, 48 e 96
Prazo: Semanas 24, 48 e 96
Semanas 24, 48 e 96
Parte 1: Porcentagem de participantes livres de nova atividade de ressonância magnética no cérebro (livre de lesões intensificadas por gadolínio [Gd] e lesões hiperintensas T2 novas ou recentemente ampliadas) nas semanas 24, 48 e 96
Prazo: Semanas 24, 48 e 96
Semanas 24, 48 e 96
Parte 1: Número de lesões hiperintensas T2 novas ou recém-aumentadas em exames de ressonância magnética cerebral nas semanas 24, 48 e 96
Prazo: Semanas 24, 48 e 96
Semanas 24, 48 e 96
Parte 1: Número de lesões de aumento de Gd em varreduras de ressonância magnética cerebral nas semanas 24, 48 e 96
Prazo: Semanas 24, 48 e 96
Semanas 24, 48 e 96
Parte 1: Tempo para a primeira recaída
Prazo: Até a semana 96
Até a semana 96
Parte 1: Área sob a curva de concentração de plasma-tempo do tempo zero até o final do intervalo de dosagem (AUCtau) para BIIB017
Prazo: Dentro de 8 horas após a dose no Dia 1 da Semana 1; Dentro de 8 horas, 48 ​​e 120 horas após a dose no Dia 1 da Semana 4; Dentro de 8 horas após a dose no dia 1 da semana 24
Dentro de 8 horas após a dose no Dia 1 da Semana 1; Dentro de 8 horas, 48 ​​e 120 horas após a dose no Dia 1 da Semana 4; Dentro de 8 horas após a dose no dia 1 da semana 24
Parte 1: Concentração plasmática máxima observada (Cmax) em estado estacionário para BIIB017
Prazo: Dentro de 8 horas após a dose no Dia 1 da Semana 1; Dentro de 8 horas, 48 ​​e 120 horas após a dose no Dia 1 da Semana 4; Dentro de 8 horas após a dose no dia 1 da semana 24
Dentro de 8 horas após a dose no Dia 1 da Semana 1; Dentro de 8 horas, 48 ​​e 120 horas após a dose no Dia 1 da Semana 4; Dentro de 8 horas após a dose no dia 1 da semana 24
Parte 1: Tempo para atingir a concentração plasmática máxima observada (Tmax) no estado estacionário para BIIB017
Prazo: Dentro de 8 horas após a dose no Dia 1 da Semana 1; Dentro de 8 horas, 48 ​​e 120 horas após a dose no Dia 1 da Semana 4; Dentro de 8 horas após a dose no dia 1 da semana 24
Dentro de 8 horas após a dose no Dia 1 da Semana 1; Dentro de 8 horas, 48 ​​e 120 horas após a dose no Dia 1 da Semana 4; Dentro de 8 horas após a dose no dia 1 da semana 24
Parte 1: Porcentagem de participantes livres de recaída nas semanas 48 e 96
Prazo: Semanas 48 e 96
Semanas 48 e 96
Parte 1: Mudança da linha de base na altura nas semanas 24, 48, 72, 96 e 100
Prazo: Linha de base, semanas 24, 48, 72, 96 e 100
Linha de base, semanas 24, 48, 72, 96 e 100
Parte 1: Mudança da linha de base no peso nas semanas 24, 48, 72, 96 e 100
Prazo: Linha de base, semanas 24, 48, 72, 96 e 100
Linha de base, semanas 24, 48, 72, 96 e 100
Parte 1: Alteração da linha de base na pressão arterial nas semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Prazo: Linha de base, semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Linha de base, semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Parte 1: Mudança da linha de base na frequência de pulso nas semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Prazo: Linha de base, semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Linha de base, semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Parte 1: Mudança da temperatura corporal basal nas semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Prazo: Linha de base, semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Linha de base, semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Parte 1: Alteração da frequência respiratória basal nas semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Prazo: Linha de base, semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Linha de base, semanas 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 e 100
Parte 1: Alteração da linha de base nos parâmetros do eletrocardiograma (ECG) de 12 derivações nas semanas 48, 96 e 100
Prazo: Linha de base (antes da dosagem), semanas 48, 96 e 100
Linha de base (antes da dosagem), semanas 48, 96 e 100
Parte 2: Mudança da Altura da Linha de Base nas Semanas 120, 144, 168, 192 e 196
Prazo: Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Parte 2: Mudança da linha de base no peso nas semanas 120, 144, 168, 192 e 196
Prazo: Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Parte 2: Mudança da linha de base na pressão arterial nas semanas 120.144.168, 192 e 196
Prazo: Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Parte 2: Mudança da linha de base na frequência de pulso nas semanas 120, 144, 168, 192 e 196
Prazo: Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Parte 2: Mudança da temperatura corporal basal nas semanas 120, 144, 168, 192 e 196
Prazo: Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Parte 2: Alteração da frequência respiratória basal nas semanas 120, 144, 168, 192 e 196
Prazo: Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Linha de base (semana 96), semanas 120, 144, 168, 192 e 196
Parte 2: Alteração da linha de base nos parâmetros de ECG de 12 derivações nas semanas 144, 192 e 196
Prazo: Linha de base (semana 96), semanas 144, 192 e 196
Linha de base (semana 96), semanas 144, 192 e 196
Part 1: ARR at Week 96
Prazo: Week 96

An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. ARR is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.
Week 96
Part 1: Change from Baseline in Cognition at Weeks 24, 48, 72, and 96 as Measured by the Symbol Digit Modality Test (SDMT)
Prazo: Baseline, Weeks 24, 48, 72, and 96

The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0 (worst) to 110 (best) in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. Higher scores indicate better performance.
Baseline, Weeks 24, 48, 72, and 96
Part 1: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96
Prazo: Baseline, Weeks 48, and 96

EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS).
Baseline, Weeks 48, and 96
Part 1: Change from Baseline in the Quality of Life as Measured by the Pediatric Quality of Life Inventory (PedsQL) at Weeks 24, 48, 72 and 96
Prazo: Baseline, Weeks 24, 48, 72 and 96

The PedsQL consists of 23 items in four generic score scales: physical functioning, emotional functioning, social functioning, and school functioning that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Baseline, Weeks 24, 48, 72 and 96
Part 1: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation
Prazo: Up to Week 100

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
Up to Week 100
Part 1: Change from Baseline in Tanner Score at Weeks 24, 48, 72, 96, and 100
Prazo: Baseline, Weeks 24, 48, 72, 96, and 100

Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected for all male participants with bone age less than (<) 16 years and for female participants who are pre-menarche and have a bone age < 16 years and will be stopped once the participant's bone age reaches greater than or equal to (>=) 16 years or (once the participant is post-menarche. Tanner Score can be omitted if required by country-specific regulations and/or local ethics committees.
Baseline, Weeks 24, 48, 72, 96, and 100
Part 1: Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN β-1a) [All Participants]
Prazo: Up to Week 96

Presence of IFN β-1a antibodies in human serum will be determined using enzyme-linked immunosorbent assay (ELISA) followed by further characterization and titration of positive samples in a cell-based neutralizing antibody assay.
Up to Week 96
Part 1: Number of Participants With Binding Antibodies to Peginterferon (PEG) [BIIB017-Treated Participants]
Prazo: Up to Week 96

Anti-PEG binding antibodies in human serum will be determined using an ELISA.
Up to Week 96
Part 1: Change from Baseline in Depression as Assessed by Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Weeks 12, 24, 36, 48, 60, 72, 84, 96, and 100
Prazo: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, and 100

MINI-KID is a short (approximately 15 minute) structured diagnostic interview used to assess the presence of 20 diagnostic and statistical manual of mental disorders, 4th Edition (DSM-IV) child and adolescent psychiatric disorders as well as the risk of suicide. The MINI-Kid frames questions in language that is easy for children and adolescents. It consists of 137 questions across 24 modules.
Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, and 100
Part 1: Percentage of Participants with Changes Over Time in Clinical Laboratory Values
Prazo: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100

Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
Part 2: ARR at Weeks 144 and 192
Prazo: Weeks 144 and 192

An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. ARR is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.
Weeks 144 and 192
Part 2: Change from Baseline in EDSS Score at Weeks 120, 144, 168, 192, and 196
Prazo: Baseline (Week 96), Weeks 120, 144, 168, 192, and 196

EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS).
Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in Tanner Score at Weeks 120, 144, 168, 192, and 196
Prazo: Baseline (Week 96), Weeks 120, 144, 168, 192, and 196

Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected for all male participants with bone age < 16 years and for female participants who are pre-menarche and have a bone age <16 years and will be stopped once the participant's bone age reaches >= 16 years or (once the participant is post-menarche. Tanner Score can be omitted if required by country-specific regulations and/or local ethics committees.
Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Number of Participants With Binding and Neutralizing Antibodies to IFN β-1a (All Participants)
Prazo: Up to Week 192

Presence of IFN β-1a antibodies in human serum will be determined using ELISA followed by further characterization and titration of positive samples in a cell-based neutralizing antibody assay.
Up to Week 192
Part 2: Number of Participants With Binding Antibodies to PEG (BIIB017-Treated Participants)
Prazo: Up to Week 192

Anti-PEG binding antibodies in human serum will be determined using an ELISA.
Up to Week 192
Part 2: Change from Baseline in Depression as Assessed by Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Weeks 108, 120, 132, 144,156, 168, 180, 192, and 196
Prazo: Baseline (Week 96), Weeks 108, 120, 132, 144,156, 168, 180, 192, and 196

MINI-KID is a structured diagnostic interview instrument for psychiatric evaluation and outcome tracking. All questions are answered Yes or No.
Baseline (Week 96), Weeks 108, 120, 132, 144,156, 168, 180, 192, and 196
Part 2: Percentage of Participants with Changes Over Time in Clinical Laboratory Values
Prazo: Baseline (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192, and 196

Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.
Baseline (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192, and 196

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Biogen

Investigadores

  • Diretor de estudo: Medical Director, Biogen

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de outubro de 2019

Conclusão Primária (Estimado)

20 de maio de 2027

Conclusão do estudo (Estimado)

20 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

20 de maio de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de maio de 2019

Primeira postagem (Real)

22 de maio de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 105MS306
  • 2018 (Concessão/Contrato do NIH dos EUA)
  • 2018-003008-38 (Número EudraCT)
  • 2023-505624-56 (Outro identificador: EU CTIS)
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever