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
Running, not enrolling · Phase 3
Conditions studied: Multiple Sclerosis, Relapsing-Remitting
In brief
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.
Key facts
- Study ID
- NCT03958877
- Run by
- Biogen
- People needed
- 152
- Starts
- 2019-10-18
- Expected to finish
- 2027-05-20
- Last updated by the study team
- 2025-09-11
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UNC Hospitals — Chapel Hill, North Carolina, United States
- Meridian Clinical Research — Norfolk, Virginia, United States
- Hospital Italiano de Buenos Aires — Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
- Royal Children's Hospital — Parkville, Victoria, Australia
- Universitair Ziekenhuis Ghent — Ghent, East Flanders, Belgium
- Clinique CHC MontLégia — Liège, Wallonia, Belgium
- MHATNP 'Sv.Naum', EAD — Sofia, Bulgaria
- University Hospital Centre Split — Split, Dalmatia, Croatia
- 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, France
- Hopital Purpan — Toulouse, Haute Garonne, France
- Hopital Gui de Chauliac — Montpellier, Herault, France
- Hopital Roger Salengro - CHU Lille — Lille, Nord, France
- Hôpital Bicêtre — Le Kremlin-Bicêtre, Val De Marne, France
- Universitaetsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Universitaetsmedizin Goettingen — Göttingen, Lower Saxony, Germany
- St. Josef-Hospital Universitaetsklinikum — Bochum, North Rhine-Westphalia, Germany
- Charité - Campus Virchow-Klinikum — Berlin, Germany
- General Hospital of Larissa — Larissa, Thessaly, Greece
- General Hospital of Thessaloniki 'Hippokration' — Thessaloniki, Greece
- Pecsi Tudomanyegyetem KK — Pécs, Baranya, Hungary
- UC San Diego Health — La Jolla, California, United States
Full record on ClinicalTrials.gov
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