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

NCT03958877 · tracked via the Priya Life Science Turkey tracker

Sponsor

Biogen

Phase

Phase 3

Started

2019-10-18

Last updated

2026-09-24

Condition(s) studied

Multiple Sclerosis, Relapsing-Remitting

Investigational drug(s) / intervention(s)

BIIB017 (peginterferon beta-1a) →Interferon beta type 1a →

BIIB017 (peginterferon beta-1a): Administered as specified in the treatment arm

Interferon beta type 1a: Administered as specified in the treatment arm

Study summary

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.

Eligibility

Sex

ALL

Min age

10 Years

Max age

18 Years

Healthy volunteers

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.

Primary outcome measure(s)

Part 1: Annualized Relapse Rate (ARR) at Week 48 — 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.
Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Treatment Discontinuation — 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.

Trial sites (65)

Facility	City	Region
UC San Diego Health	La Jolla	California
UNC Hospitals	Chapel Hill	North Carolina
Meridian Clinical Research	Norfolk	Virginia
Hospital Italiano de Buenos Aires	Ciudad Autonoma Buenos Aires	Buenos Aires
Royal Children's Hospital	Parkville	Victoria
Universitair Ziekenhuis Ghent	Ghent	East Flanders
Clinique CHC MontLégia	Liège	Wallonia
MHATNP 'Sv.Naum', EAD	Sofia	Bulgaria
University Hospital Centre Split	Split	Dalmatia
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
Hopital Purpan	Toulouse	Haute Garonne
Hopital Gui de Chauliac	Montpellier	Herault
Hopital Roger Salengro - CHU Lille	Lille	Nord
Hôpital Bicêtre	Le Kremlin-Bicêtre	Val De Marne
Universitaetsklinikum Freiburg	Freiburg im Breisgau	Baden-Wurttemberg
Universitaetsmedizin Goettingen	Göttingen	Lower Saxony
St. Josef-Hospital Universitaetsklinikum	Bochum	North Rhine-Westphalia
Charité - Campus Virchow-Klinikum	Berlin	Germany
General Hospital of Larissa	Larissa	Thessaly
General Hospital of Thessaloniki 'Hippokration'	Thessaloniki	Greece
Pecsi Tudomanyegyetem KK	Pécs	Baranya
Debreceni Egyetem	Debrecen	Hajdú-Bihar
Semmelweis Egyetem	Budapest	Hungary
Hadassah University Hospital - Ein Kerem	Jerusalem	Levant
Schneider Children's Medical Center	Petach-Tikva	Tel Aviv
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer	Florence	Italy
Azienda Ospedaliera Universitaria 'Federico II'	Naples	Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"	Naples	Italy
Ibn Sina Hospital	Ash Shuwaykh	Shuwaikh
Centro Hospitalar e Universitário Lisboa Norte E.P.E.	Lisbon	Lisbon District
Hospital Beatriz Ângelo	Loures	Lisbon District
Hospital de Braga	Braga	Minho
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
FSBI "Federal Siberian Scientific-Clinical Center of FMBA"	Krasnoyarsk	Krasnoyarsk Krai

+ 25 more sites — see the full list on the official registry below.

More Biogen trials in Turkey

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A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia Active, not recruiting

Other trials for the same condition

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis Recruiting

Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03958877 on ClinicalTrials.gov ↗ ← All trials in Turkey