Multiple Sclerosis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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. 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"

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

142

Study ID:

NCT03958877

Recruitment Status:

Recruiting

Sponsor:

Biogen

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 63 Locations for this study

See Locations Near You

UC San Diego Health
San Diego California, 92121, United States More Info
Contact
8582462384
Jennifer Sharon Graves
Principal Investigator
UNC Hospitals
Chapel Hill North Carolina, 27514, United States More Info
Contact
919-945-4752
Irena Dujmovic Basuroski
Principal Investigator
Meridian Clinical Research
Norfolk Virginia, 23502, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires Buenos Aires, C1181, Argentina More Info
Contact
541121131241
Clarisa Maxit
Principal Investigator
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Universitair Ziekenhuis Gent
Gent East Flanders, 9000, Belgium More Info
Contact
3293323597
Helene Verhelst
Principal Investigator
Clinique CHC MontLégia
Liege Wallonia, 4000, Belgium More Info
Contact
3242248911
Annick Melin
Principal Investigator
MHATNP "Sv.Naum", EAD
Sofia , 1113, Bulgaria More Info
Contact
35929702100
Veneta Bojinova-Tchamova
Principal Investigator
University Hospital Centre Split
Split Dalmatia, 21000, Croatia More Info
Contact
38521556288
Eugenija Marusic
Principal Investigator
Children's Hospital Zagreb
Zagreb , 10000, Croatia More Info
Contact
38514600138
Vlasta Djuranovic
Principal Investigator
Clinical Hospital 'Sestre Milosrdnice'
Zagreb , 10000, Croatia More Info
Contact
38513787111
Masa Malenica
Principal Investigator
University Hospital Centre Zagreb
Zagreb , 10000, Croatia More Info
Contact
38512388310
Mario Habek
Principal Investigator
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 50333, Czechia More Info
Contact
420495835214
Martin Valis
Principal Investigator
CHU Strasbourg - Hôpital Hautepierre
Strasbourg Bas Rhin, 67098, France More Info
Contact
33388128544
Jerome De Seze
Principal Investigator
Hopital Purpan
Toulouse cedex 9 Haute Garonne, 31059, France More Info
Contact
33534557408
Emmanuel Cheuret
Principal Investigator
Hopital Gui de Chauliac
Montpellier Herault, 34295, France More Info
Contact
33467337422
Pierre Meyer
Principal Investigator
Hopital Roger Salengro - CHU Lille
Lille Nord, 59037, France More Info
Contact
33320445962
Helene Zephir
Principal Investigator
Hôpital Bicêtre
Le Kremlin Bicêtre cedex Val De Marne, 94275, France More Info
Contact
33145213112
Kumaran Deiva
Principal Investigator
Universitaetsklinikum Freiburg
Freiburg Baden Wuerttemberg, 79106, Germany More Info
Contact
4976127045900
Matthias Eckenweiler
Principal Investigator
Universitaetsmedizin Goettingen
Gottingen Niedersachsen, 37075, Germany More Info
Contact
49551398035
Jutta Gaertner
Principal Investigator
St. Josef-Hospital Universitaetsklinikum
Bochum Nordrhein Westfalen, 44791, Germany More Info
Contact
492345092687
Thomas Luecke
Principal Investigator
Charité - Campus Virchow-Klinikum
Berlin , 13353, Germany More Info
Contact
4930450566112
Angela Kaindl
Principal Investigator
General Hospital of Larissa
Larissa Thessaly, 41110, Greece More Info
Contact
3021413502745
Efthymios Dardiotis
Principal Investigator
IASO Children's Hospital
Marousi , 15123, Greece
General Hospital of Thessaloniki 'Hippokration'
Thessaloniki , 54642, Greece More Info
Contact
302313312437
Dimitrios Zafeiriou
Principal Investigator
Pecsi Tudomanyegyetem
Pecs Baranya, 7623, Hungary More Info
Contact
3672535900
Katalin Dr. Ohmachtne Hollody
Principal Investigator
Debreceni Egyetem
Debrecen Hajdú-Bihar, 4032, Hungary More Info
Contact
36709450368
Monika Bessenyei
Principal Investigator
Semmelweis Egyetem AOK
Budapest , 1083, Hungary More Info
Contact
+3614591500
Viktor Farkas
Principal Investigator
Hadassah University Hospital - Ein Kerem
Jerusalem Levant, 91120, Israel More Info
Contact
97226776936
Adi Vaknin-Dembinsky
Principal Investigator
Schneider Children's Medical Center
Petach-Tikva Tel Aviv, 49202, Israel More Info
Contact
97239253875
Esther Ganelin-Cohen
Principal Investigator
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli Campania, 80138, Italy More Info
Contact
39815666788
Giacomo Lus
Principal Investigator
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Firenze , 50139, Italy More Info
Contact
39555662705
Federico Melani
Principal Investigator
Azienda Ospedaliera Universitaria 'Federico II'
Napoli , 80131, Italy More Info
Contact
39817462670
Vincenzo Brescia Morra
Principal Investigator
Ibn Sina Hospital
Shuwaikh , 12345, Kuwait More Info
Contact
96599304949
Raed Al Roughani
Principal Investigator
Centro Hospitalar e Universitário Lisboa Norte E.P.E.
Lisboa Lisbon, 1649-, Portugal More Info
Contact
351912263284
Joao De Sa
Principal Investigator
Hospital Beatriz Ângelo
Loures Lisbon, 2674-, Portugal More Info
Contact
351214348200
Ângela Timoteo
Principal Investigator
Hospital de Braga
Braga Minho, 4710-, Portugal More Info
Contact
351915301556
Joao Jose Cerqueira
Principal Investigator
Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico
Coimbra , 3000-, Portugal More Info
Contact
351239800052
Filipe Palavra
Principal Investigator
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
Porto , 4099-, Portugal More Info
Contact
351222077500
Sonia Figueiroa
Principal Investigator
SBEI HPE 'Bashkir State Medical University' of the MoH of the RF
Ufa Bashkortostan, 45007, Russian Federation
FSBI "Federal Siberian Scientific-Clinical Center of FMBA"
Krasnoyarsk Krasnoyarsk Krai, 66003, Russian Federation
LLC National center for socially significan disease
St. Petersburg Leningrad, 19711, Russian Federation
Nebbiolo LLC
Tomsk Oblast, 63400, Russian Federation
SAIH 'Kemerovo Regional Clinical Hospital'
Kemerovo Siberia, 65006, Russian Federation
RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'
Belgorod , 30800, Russian Federation
SBHI
Moscow , 11960, Russian Federation
SBIH of Moscow region "Moscow Regional Scientific & Research
Moscow , 12911, Russian Federation
SBEI HPE 'Rostov State Medical University' of the MoH of the RF
Rostov-on-Don , 34402, Russian Federation
State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'
Yaroslavl , 15000, Russian Federation
King Faisal Specialist Hospital & Research Center
Jeddah Makkah, 40047, Saudi Arabia More Info
Contact
966555996542
Ebtesam S. Alshehri
Principal Investigator
King Saud University
Riyadh , 11472, Saudi Arabia More Info
Contact
966504483865
Nuha Al Khawajah
Principal Investigator
Clinic of Neurology and Psychiatry for Children and Youth
Belgrade Balkans, 11000, Serbia More Info
Contact
381112658355
Jasna Jancic
Principal Investigator
University Children's Hospital
Belgrade Balkans, 11000, Serbia More Info
Contact
38163404063
Dimitrije Nikolic
Principal Investigator
Mother and Child Health Care Institute of Serbia ''Dr Vukan Cupic''
Belgrade Balkans, 11070, Serbia More Info
Contact
381113108144
Slavica Ostojic
Principal Investigator
Narodny ustav detskych chorob
Bratislava , 83340, Slovakia More Info
Contact
421259371100
Miriam Kolnikova
Principal Investigator
Hospital Sant Joan de Deu
Esplugues de Llobregat Barcelona, 08950, Spain More Info
Contact
34932271738
Thais Armangue Salvador
Principal Investigator
Hospital Universitario Virgen de la Arrixaca
El Palmar Murcia, 30120, Spain More Info
Contact
34968369534
Jose Eustasio Meca Lallana
Principal Investigator
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain More Info
Contact
34957012580
Eduardo Aguera Morales
Principal Investigator
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain More Info
Contact
34665249028
Lucienne Costa-Frossard Franca
Principal Investigator
Hopital Razi
Manouba Mannouba, 2010, Tunisia More Info
Contact
21671600339
Riadh Gouider
Principal Investigator
Hôpital Fattouma Bourghiba
Monastir , 5000, Tunisia More Info
Contact
21673106035
Mahbouba Frih
Principal Investigator
Hôpital Habib Bourguiba
Sfax , 3029, Tunisia More Info
Contact
21674106047
Chokri Mhiri
Principal Investigator
Gazi University Medical Faculty Clinical Research Unit
Ankara , 06500, Turkey More Info
Ercan Demir
Principal Investigator
Akdeniz University Medical Faculty
Antalya , 07059, Turkey More Info
Contact
905327243824
Ozgur Duman
Principal Investigator
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir , 35210, Turkey More Info
Contact
905327163537
Unsal Yilmaz
Principal Investigator
Ondokuz Mayis Univ. Med. Fac.
Samsun , 55139, Turkey More Info
Contact
903623121919
Murat Terzi
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

142

Study ID:

NCT03958877

Recruitment Status:

Recruiting

Sponsor:


Biogen

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.