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Active (not recruiting) Phase 3 NCT03958877

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

Phase 3 – large-scale trial before approval
Conditions: Multiple Sclerosis, Relapsing-Remitting

Sponsor: Biogen

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 21
Argentina (1)
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires , Buenos Aires
Australia (1)
Royal Children's Hospital
Parkville , Victoria
Belgium (1)
Universitair Ziekenhuis Ghent
Ghent , East Flanders
Bulgaria (1)
MHATNP 'Sv.Naum', EAD
Sofia
Croatia (1)
University Hospital Centre Split
Split , Dalmatia
Czech Republic (1)
Fakultni nemocnice Hradec Kralove
Hradec Králové
France (1)
CHU Strasbourg - Hôpital Hautepierre
Strasbourg , Bas Rhin
Germany (1)
Universitaetsklinikum Freiburg
Freiburg im Breisgau , Baden-Wurttemberg
Greece (1)
General Hospital of Larissa
Larissa , Thessaly
Hungary (1)
Pecsi Tudomanyegyetem KK
Pécs , Baranya
Israel (1)
Hadassah University Hospital - Ein Kerem
Jerusalem , Levant
Italy (1)
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence
Kuwait (1)
Ibn Sina Hospital
Ash Shuwaykh , Shuwaikh
Portugal (1)
Centro Hospitalar e Universitário Lisboa Norte E.P.E.
Lisbon , Lisbon District
Russia (1)
SBEI HPE 'Bashkir State Medical University' of the MoH of the RF
Ufa , Bashkortostan Republic
Saudi Arabia (1)
King Faisal Specialist Hospital & Research Center
Jeddah , Mecca Region
Serbia (1)
Clinic of Neurology and Psychiatry for Children and Youth
Belgrade , Balkans
Slovakia (1)
Narodny ustav detskych chorob
Bratislava
Spain (1)
Hospital Sant Joan de Deu
Esplugues de Llobregat , Barcelona
Tunisia (1)
Hopital Razi
Manouba , Mannouba
United States (1)
UC San Diego Health
La Jolla , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
10 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
18.10.2019
Completion date
20.05.2027
Registry ID
NCT03958877
Source
anzctr
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