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
- Diseases
- Multiple sclerosis
- 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
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Unknown status |
| Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Universitair Ziekenhuis Ghent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Clinique CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Completed |
| Charité Campus Virchow-Klinikum Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| St. Josef-Hospital Universitaetsklinikum Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Universitaetsklinikum Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital Sant Joan De Deu Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Hopital Roger Salengro, CHU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital Gui de Chauliac Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU Strasbourg - Hôpital Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Hopital Purpan Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| General Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Unknown status |
| General Hospital of Thessaloniki 'Hippokration' Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| KBC Zagreb Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Completed |
| Semmelweis Egyetem, Gyermekgyógyászati Klinika Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petach-Tikva | Israel | Unknown status |
| Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ibn Sina Hospital Coordinator of this site? Confirm its status | Ash Shuwaykh | Kuwait | Unknown status |
| Hospital de Braga Coordinator of this site? Confirm its status | Braga | Portugal | Unknown status |
| Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Centro Hospitalar e Universitário Lisboa Norte E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Hospital Beatriz Ângelo Coordinator of this site? Confirm its status | Loures | Portugal | Unknown status |
| Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Mother and Child Health Care Institute of Serbia Dr Vukan Cupic Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University Children Hospital Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinic of Neurology and Psychiatry for Children and Youth Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf' Coordinator of this site? Confirm its status | Belgorod | Russia | Unknown status |
| SAIH "Kemerovo Regional Clinical Hospital" Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| FSBI "Federal Siberian Scientific-Clinical Center of FMBA" Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Unknown status |
| SBIH of Moscow region "Moscow Regional Scientific & Research Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| SBHI Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| SBEI HPE 'Rostov State Medical University' of the MoH of the RF Coordinator of this site? Confirm its status | Rostov-on-Don | Russia | Unknown status |
| LLC National center for socially significan disease Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Nebbiolo LLC Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
| SBEI HPE 'Bashkir State Medical University' of the MoH of the RF Coordinator of this site? Confirm its status | Ufa | Russia | Unknown status |
| State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2' Coordinator of this site? Confirm its status | Yaroslavl | Russia | Unknown status |
| King Faisal Specialist Hospital & Research Center Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| King Saud University Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Narodny ustav detskych chorob Coordinator of this site? Confirm its status | Bratislava | Slovakia | Completed |
| Hopital Razi Coordinator of this site? Confirm its status | Manouba | Tunisia | Unknown status |
| Hôpital Fattouma Bourghiba Coordinator of this site? Confirm its status | Monastir | Tunisia | Unknown status |
| Hôpital Habib Bourguiba Coordinator of this site? Confirm its status | Sfax | Tunisia | Unknown status |
| UNC Hospitals Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UC San Diego Health Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Meridian Clinical Research Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Gazi University Medical Faculty Clinical Research Unit Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Akdeniz University Medical Faculty Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Ondokuz Mayis Univ. Med. Fac. Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.