Estudio abierto, aleatorizado, multicéntrico, controlado con tratamiento activo, de grupos paralelos para evaluar la seguridad, tolerabilidad y eficacia de BIIB017 en participantes pediátricos de 10 a menos de 18 años para el tratamiento de la esclerosis múltiple remitente-recurrente, con extensión abierta opcional

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03958877Tipo: INTERVENTIONALInicio: 18 de oct de 2019Fin estimado: 20 de may de 2027

Resumen

Este estudio evaluará la seguridad, tolerabilidad y eficacia descriptiva de BIIB017 en participantes pediátricos con esclerosis múltiple remitente-recurrente (EMRR), y evaluará la farmacocinética (FC) de BIIB017 en participantes pediátricos con EMRR en la Parte 1. En la Parte 2, el estudio evaluará la seguridad a largo plazo de BIIB017 y describirá la seguridad y los desenlaces a largo plazo de la esclerosis múltiple (EM) tras el tratamiento con BIIB017 en participantes que completaron el tratamiento del estudio en la Semana 96 de la Parte 1.

Elegibilidad

Edad mínima: 10 YearsEdad máxima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

BIIB017 (peginterferon beta-1a)

Administered as specified in the treatment arm

drug

Interferon beta type 1a

Administered as specified in the treatment arm

Ubicaciones

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBiogen

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