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

• ClinicalTrials.gov Identifier: NCT03958877
• Recruitment Status: Recruiting
• First Posted: May 22, 2019
• Last Update Posted: April 5, 2023
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: BIIB017 (peginterferon beta-1a); Drug: Interferon beta type 1a	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 18, 2019
• Estimated Primary Completion Date: November 5, 2029
• Estimated Study Completion Date: November 5, 2029

Arms and Interventions

Arm	Intervention/treatment
Experimental: BIIB017 (peginterferon beta-1a); Participants will receive subcutaneous (SC) injection of BIIB017 (peginterferon beta-1a) 63 microgram (μg) on Day 1, followed by 94 μg at Week 2, followed by 125 μg at Week 4, and then 125 μg SC injection every 2 weeks up to Week 96 in Part 1 of the study. Participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.	Drug: BIIB017 (peginterferon beta-1a); Administered as specified in the treatment arm; Other Name: PLEGRIDY
Active Comparator: Avonex; Participants will receive Avonex (interferon beta type 1a) starting at a dose of 7.5 μg on Day 1, followed by an increase of 7.5 μg each week for 3 weeks, followed by 30 μg intramuscular (IM) injections every week up to Week 96 in Part 1 of the study. Participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.	Drug: Interferon beta type 1a; Administered as specified in the treatment arm; Other Name: Avonex

Outcome Measures

Primary Outcome Measures :

1. Part 1: Annualized Relapse Rate (ARR) at Week 96 [ Time Frame: Week 96 ]
   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.
2. Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation [ Time Frame: 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.

Secondary Outcome Measures :

1. Part 1: ARR at Week 48 [ Time Frame: Week 48 ]
   An 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.
2. Part 1: Percentage of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 24, 48, and 96 [ Time Frame: Weeks 24, 48, and 96 ]
3. Part 1: Percentage of Participants Free of New MRI Activity in the Brain (Free of Gadolinium [Gd]-Enhancing Lesions and New or Newly Enlarging T2 Hyperintense Lesions) at Weeks 24, 48, and 96 [ Time Frame: Weeks 24, 48, and 96 ]
4. Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96 [ Time Frame: Weeks 24, 48, and 96 ]
5. Part 1: Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96 [ Time Frame: Weeks 24, 48, and 96 ]
6. Part 1: Time to First Relapse [ Time Frame: Up to Week 96 ]
7. Part 1: Percentage of Participants Free of Relapse Up to Week 96 [ Time Frame: Up to Week 96 ]
8. Part 1: Change from Baseline in Cognition at Weeks 24, 48, 72 and 96 as Measured by the Symbol Digit Modality Test (SDMT) [ Time Frame: Baseline, Weeks 24, 48, 72 and 96 ]
   The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0 (worst) to 110 (best) in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. Higher scores indicate better performance.
9. Part 1: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96 [ Time Frame: Baseline, Weeks 48 and 96 ]
   EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS).
10. Part 1: Change from Baseline in the Quality of Life as Measured by the Pediatric Quality of Life Inventory (PedsQL) at Weeks 24, 48, 72, 96 and 100 [ Time Frame: Baseline, Weeks 24, 48, 72, 96 and 100 ]
    The PedsQL consists of 23 items in four generic score scales: physical functioning, emotional functioning, social functioning, and school functioning that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
11. Part 1: Area Under the Plasma Concentration-Time Curve from Time Zero to End of Dosing Interval (AUCtau) for BIIB017 [ Time Frame: Within 8 hours postdose on Day 1 of Week 1; Within 8 hours, 48 and 120 hours postdose on Day 1 of Week 4; Within 8 hours postdose on Day 1 of Week 24 ]
12. Part 1: Maximum Observed Plasma Concentration (Cmax) at Steady State for BIIB017 [ Time Frame: Within 8 hours postdose on Day 1 of Week 1; Within 8 hours, 48 and 120 hours postdose on Day 1 of Week 4; Within 8 hours postdose on Day 1 of Week 24 ]
13. Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State for BIIB017 [ Time Frame: Within 8 hours postdose on Day 1 of Week 1; Within 8 hours, 48 and 120 hours postdose on Day 1 of Week 4; Within 8 hours postdose on Day 1 of Week 24 ]
14. Part 1: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation [ Time Frame: Up to Week 100 ]
    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.
15. Part 1: Change from Baseline in Height at Weeks 24, 48, 72, 96 and 100 [ Time Frame: Baseline, Weeks 24, 48, 72, 96 and 100 ]
16. Part 1: Change from Baseline in Weight at Weeks 24, 48, 72, 96 and 100 [ Time Frame: Baseline, Weeks 24, 48, 72, 96 and 100 ]
17. Part 1: Change from Baseline in Tanner Score at Weeks 24, 48, 72, 96 and 100 [ Time Frame: Baseline, Weeks 24, 48, 72, 96 and 100 ]
    Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected for all male participants with bone age less than (<) 16 years and for female participants who are pre-menarche and have a bone age < 16 years and will be stopped once the participant's bone age reaches greater than or equal to (>=) 16 years or (once the participant is post-menarche. Tanner Score can be omitted if required by country-specific regulations and/or local ethics committees.
18. Part 1: Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN β-1a) [All Participants] [ Time Frame: Up to Week 96 ]
    Presence of IFN β-1a antibodies in human serum will be determined using enzyme-linked immunosorbent assay (ELISA) followed by further characterization and titration of positive samples in a cell-based neutralizing antibody assay.
19. Part 1: Number of Participants With Binding Antibodies to Peginterferon (PEG) [BIIB017-Treated Participants] [ Time Frame: Up to Week 96 ]
    Anti-PEG binding antibodies in human serum will be determined using an ELISA.
20. Part 1: Change from Baseline in Depression as Assessed by Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Weeks 12, 24, 36, 48, 60, 72, 84, 96 and 100 [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96 and 100 ]
    MINI-KID is a short (approximately 15 minute) structured diagnostic interview used to assess the presence of 20 diagnostic and statistical manual of mental disorders, 4th Edition (DSM-IV) child and adolescent psychiatric disorders as well as the risk of suicide. The MINI-Kid frames questions in language that is easy for children and adolescents. It consists of 137 questions across 24 modules.
21. Part 1: Change from Baseline in Blood Pressure at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100 [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100 ]
22. Part 1: Change from Baseline in Heart Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100 [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100 ]
23. Part 1: Change from Baseline in Body Temperature at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100 [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100 ]
24. Part 1: Change from Baseline in Respiratory Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100 [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84,96 and 100 ]
25. Part 1: Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Weeks 48, 96 and 100 [ Time Frame: Baseline (Before dosing), Weeks 48, 96 and 100 ]
26. Part 1: Percentage of Participants with Changes Over Time in Clinical Laboratory Values [ Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100 ]
    Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.
27. Part 2: ARR at Weeks 144 and 192 [ Time Frame: Weeks 144 and 192 ]
    An 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.
28. Part 2: Change from Baseline in EDSS Score at Weeks 120, 144, 168, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 120, 144, 168, 192 and 196 ]
    EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS).
29. Part 2: Change from Baseline in Height at Weeks 120, 144, 168, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 120, 144, 168, 192 and 196 ]
30. Part 2: Change from Baseline in Weight at Weeks 120, 144, 168, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 120, 144, 168, 192 and 196 ]
31. Part 2: Change from Baseline in Tanner Score at Weeks 120, 144, 168, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 120, 144, 168, 192 and 196 ]
    Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected for all male participants with bone age < 16 years and for female participants who are pre-menarche and have a bone age <16 years and will be stopped once the participant's bone age reaches >= 16 years or (once the participant is post-menarche. Tanner Score can be omitted if required by country-specific regulations and/or local ethics committees.
32. Part 2: Number of Participants With Binding and Neutralizing Antibodies to IFN β-1a (All Participants) [ Time Frame: Up to Week 192 ]
    Presence of IFN β-1a antibodies in human serum will be determined using ELISA followed by further characterization and titration of positive samples in a cell-based neutralizing antibody assay.
33. Part 2: Number of Participants With Binding Antibodies to PEG (BIIB017-Treated Participants) [ Time Frame: Up to Week 192 ]
    Anti-PEG binding antibodies in human serum will be determined using an ELISA.
34. Part 2: Change from Baseline in Blood Pressure at Weeks 120,144,168,192 and 196 [ Time Frame: Baseline (Week 96), Weeks 120, 144, 168, 192 and 196 ]
35. Part 2: Change from Baseline in Heart Rate at Weeks 120, 144, 168, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 120, 144, 168, 192 and 196 ]
36. Part 2: Change from Baseline in Body Temperature at Weeks 120, 144, 168, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 120, 144, 168, 192 and 196 ]
37. Part 2: Change from Baseline in Respiratory Rate at Weeks 120, 144, 168, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 120, 144, 168, 192 and 196 ]
38. Part 2: Change from Baseline in 12-Lead ECG Parameters at Weeks 144, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 144, 192 and 196 ]
39. Part 2: Change from Baseline in Depression as Assessed by Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Weeks 108, 120, 132, 144,156, 168, 180, 192 and 196 [ Time Frame: Baseline (Week 96), Weeks 108, 120, 132, 144,156, 168, 180, 192 and 196 ]
    MINI-KID is a structured diagnostic interview instrument for psychiatric evaluation and outcome tracking. All questions are answered Yes or No.
40. Part 2: Percentage of Participants with Changes Over Time in Clinical Laboratory Values [ Time Frame: Baseline (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192 and 196 ]
    Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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"

Contacts and Locations

Contacts

Contact: US Biogen Clinical Trial Center; 866-633-4636; clinicaltrials@biogen.com

Contact: Global Biogen Clinical Trial Center; clinicaltrials@biogen.com

Locations

United States, California

UC San Diego Health; Recruiting

San Diego, California, United States, 92121

Contact 8582462384

Principal Investigator: Jennifer Sharon Graves

United States, North Carolina

UNC Hospitals; Recruiting

Chapel Hill, North Carolina, United States, 27514

Contact 919-945-4752

Principal Investigator: Irena Dujmovic Basuroski

United States, Virginia

Meridian Clinical Research; Completed

Norfolk, Virginia, United States, 23502

Argentina

Hospital Italiano de Buenos Aires; Recruiting

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH

Contact 541121131241

Principal Investigator: Clarisa Maxit

Australia, Victoria

Royal Children's Hospital; Recruiting

Parkville, Victoria, Australia, 3052

Belgium

Universitair Ziekenhuis Gent; Recruiting

Gent, East Flanders, Belgium, 9000

Contact 3293323597

Principal Investigator: Helene Verhelst

Clinique CHC MontLégia; Recruiting

Liege, Wallonia, Belgium, 4000

Contact 3242248911

Principal Investigator: Annick Melin

Bulgaria

MHATNP "Sv.Naum", EAD; Recruiting

Sofia, Bulgaria, 1113

Contact 35929702100

Principal Investigator: Veneta Bojinova-Tchamova

Croatia

University Hospital Centre Split; Recruiting

Split, Dalmatia, Croatia, 21000

Contact 38521556288

Principal Investigator: Eugenija Marusic

Children's Hospital Zagreb; Recruiting

Zagreb, Croatia, 10000

Contact 38514600138

Principal Investigator: Vlasta Djuranovic

Clinical Hospital 'Sestre Milosrdnice'; Recruiting

Zagreb, Croatia, 10000

Contact 38513787111

Principal Investigator: Masa Malenica

University Hospital Centre Zagreb; Recruiting

Zagreb, Croatia, 10000

Contact 38512388310

Principal Investigator: Mario Habek

Czechia

Fakultni nemocnice Hradec Kralove; Recruiting

Hradec Kralove, Czechia, 50333

Contact 420495835214

Principal Investigator: Martin Valis

France

CHU Strasbourg - Hôpital Hautepierre; Recruiting

Strasbourg, Bas Rhin, France, 67098

Contact 33388128544

Principal Investigator: Jerome De Seze

Hopital Purpan; Recruiting

Toulouse cedex 9, Haute Garonne, France, 31059

Contact 33534557408

Principal Investigator: Emmanuel Cheuret

Hopital Gui de Chauliac; Recruiting

Montpellier, Herault, France, 34295

Contact 33467337422

Principal Investigator: Pierre Meyer

Hopital Roger Salengro - CHU Lille; Recruiting

Lille, Nord, France, 59037

Contact 33320445962

Principal Investigator: Helene Zephir

Hôpital Bicêtre; Recruiting

Le Kremlin Bicêtre cedex, Val De Marne, France, 94275

Contact 33145213112

Principal Investigator: Kumaran Deiva

Germany

Universitaetsklinikum Freiburg; Recruiting

Freiburg, Baden Wuerttemberg, Germany, 79106

Contact 4976127045900

Principal Investigator: Matthias Eckenweiler

Universitaetsmedizin Goettingen; Recruiting

Gottingen, Niedersachsen, Germany, 37075

Contact 49551398035

Principal Investigator: Jutta Gaertner

St. Josef-Hospital Universitaetsklinikum; Recruiting

Bochum, Nordrhein Westfalen, Germany, 44791

Contact 492345092687

Principal Investigator: Thomas Luecke

Charité - Campus Virchow-Klinikum; Recruiting

Berlin, Germany, 13353

Contact 4930450566112

Principal Investigator: Angela Kaindl

Greece

General Hospital of Larissa; Recruiting

Larissa, Thessaly, Greece, 41110

Contact 3021413502745

Principal Investigator: Efthymios Dardiotis

IASO Children's Hospital; Withdrawn

Marousi, Greece, 15123

General Hospital of Thessaloniki 'Hippokration'; Recruiting

Thessaloniki, Greece, 54642

Contact 302313312437

Principal Investigator: Dimitrios Zafeiriou

Hungary

Pecsi Tudomanyegyetem; Recruiting

Pecs, Baranya, Hungary, 7623

Contact 3672535900

Principal Investigator: Katalin Dr. Ohmachtne Hollody

Debreceni Egyetem; Recruiting

Debrecen, Hajdú-Bihar, Hungary, 4032

Contact 36709450368

Principal Investigator: Monika Bessenyei

Semmelweis Egyetem AOK; Recruiting

Budapest, Hungary, 1083

Contact +3614591500 ext 52695

Principal Investigator: Viktor Farkas

Israel

Hadassah University Hospital - Ein Kerem; Recruiting

Jerusalem, Levant, Israel, 9112001

Contact 97226776936

Principal Investigator: Adi Vaknin-Dembinsky

Schneider Children's Medical Center; Recruiting

Petach-Tikva, Tel Aviv, Israel, 4920235

Contact 97239253875

Principal Investigator: Esther Ganelin-Cohen

Italy

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"; Recruiting

Napoli, Campania, Italy, 80138

Contact 39815666788

Principal Investigator: Giacomo Lus

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer; Recruiting

Firenze, Italy, 50139

Contact 39555662705

Principal Investigator: Federico Melani

Azienda Ospedaliera Universitaria 'Federico II'; Recruiting

Napoli, Italy, 80131

Contact 39817462670

Principal Investigator: Vincenzo Brescia Morra

Kuwait

Ibn Sina Hospital; Recruiting

Shuwaikh, Kuwait, 12345

Contact 96599304949

Principal Investigator: Raed Al Roughani

Portugal

Centro Hospitalar e Universitário Lisboa Norte E.P.E.; Recruiting

Lisboa, Lisbon, Portugal, 1649-035

Contact 351912263284

Principal Investigator: Joao De Sa

Hospital Beatriz Ângelo; Recruiting

Loures, Lisbon, Portugal, 2674-514

Contact 351214348200

Principal Investigator: Ângela Timoteo

Hospital de Braga; Recruiting

Braga, Minho, Portugal, 4710-243

Contact 351915301556

Principal Investigator: Joao Jose Cerqueira

Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico; Recruiting

Coimbra, Portugal, 3000-602

Contact 351239800052

Principal Investigator: Filipe Palavra

Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António; Recruiting

Porto, Portugal, 4099-001

Contact 351222077500

Principal Investigator: Sonia Figueiroa

Russian Federation

SBEI HPE 'Bashkir State Medical University' of the MoH of the RF; Active, not recruiting

Ufa, Bashkortostan, Russian Federation, 450077

FSBI "Federal Siberian Scientific-Clinical Center of FMBA"; Active, not recruiting

Krasnoyarsk, Krasnoyarsk Krai, Russian Federation, 660037

LLC National center for socially significan disease; Active, not recruiting

St. Petersburg, Leningrad, Russian Federation, 197110

Nebbiolo LLC; Completed

Tomsk, Oblast, Russian Federation, 634009

SAIH 'Kemerovo Regional Clinical Hospital'; Active, not recruiting

Kemerovo, Siberia, Russian Federation, 650066

RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'; Active, not recruiting

Belgorod, Russian Federation, 308007

SBHI; Active, not recruiting

Moscow, Russian Federation, 119602

SBIH of Moscow region "Moscow Regional Scientific & Research; Active, not recruiting

Moscow, Russian Federation, 129110

SBEI HPE 'Rostov State Medical University' of the MoH of the RF; Active, not recruiting

Rostov-on-Don, Russian Federation, 344022

State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'; Active, not recruiting

Yaroslavl, Russian Federation, 150000

Saudi Arabia

King Faisal Specialist Hospital & Research Center; Recruiting

Jeddah, Makkah, Saudi Arabia, 40047

Contact 966555996542

Principal Investigator: Ebtesam S. Alshehri

King Saud University; Recruiting

Riyadh, Saudi Arabia, 11472

Contact 966504483865

Principal Investigator: Nuha Al Khawajah

Serbia

Clinic of Neurology and Psychiatry for Children and Youth; Recruiting

Belgrade, Balkans, Serbia, 11000

Contact 381112658355

Principal Investigator: Jasna Jancic

University Children's Hospital; Recruiting

Belgrade, Balkans, Serbia, 11000

Contact 38163404063

Principal Investigator: Dimitrije Nikolic

Mother and Child Health Care Institute of Serbia ''Dr Vukan Cupic''; Recruiting

Belgrade, Balkans, Serbia, 11070

Contact 381113108144

Principal Investigator: Slavica Ostojic

Slovakia

Narodny ustav detskych chorob; Recruiting

Bratislava, Slovakia, 83340

Contact 421259371100

Principal Investigator: Miriam Kolnikova

Spain

Hospital Sant Joan de Deu; Recruiting

Esplugues de Llobregat, Barcelona, Spain, 08950

Contact 34932271738

Principal Investigator: Thais Armangue Salvador

Hospital Universitario Virgen de la Arrixaca; Recruiting

El Palmar, Murcia, Spain, 30120

Contact 34968369534

Principal Investigator: Jose Eustasio Meca Lallana

Hospital Universitario Reina Sofia; Recruiting

Cordoba, Spain, 14004

Contact 34957012580

Principal Investigator: Eduardo Aguera Morales

Hospital Universitario Ramon y Cajal; Recruiting

Madrid, Spain, 28034

Contact 34665249028

Principal Investigator: Lucienne Costa-Frossard Franca

Tunisia

Hopital Razi; Recruiting

Manouba, Mannouba, Tunisia, 2010

Contact 21671600339

Principal Investigator: Riadh Gouider

Hôpital Fattouma Bourghiba; Recruiting

Monastir, Tunisia, 5000

Contact 21673106035

Principal Investigator: Mahbouba Frih

Hôpital Habib Bourguiba; Recruiting

Sfax, Tunisia, 3029

Contact 21674106047

Principal Investigator: Chokri Mhiri

Turkey

Gazi University Medical Faculty Clinical Research Unit; Recruiting

Ankara, Turkey, 06500

Contact +90 532 325 19 83

Principal Investigator: Ercan Demir

Akdeniz University Medical Faculty; Recruiting

Antalya, Turkey, 07059

Contact 905327243824

Principal Investigator: Ozgur Duman

Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi; Recruiting

Izmir, Turkey, 35210

Contact 905327163537

Principal Investigator: Unsal Yilmaz

Ondokuz Mayis Univ. Med. Fac.; Recruiting

Samsun, Turkey, 55139

Contact 903623121919

Principal Investigator: Murat Terzi

Sponsors and Collaborators

Biogen

Investigators

• Study Director: Medical Director; Biogen

More Information

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT03958877
• Other Study ID Numbers: 105MS306; 2018-003008-38 ( EudraCT Number )
• First Posted: May 22, 2019
• Last Update Posted: April 5, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
• URL: https://vivli.org/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Interferons; Interferon-beta; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs