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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Drug: BIIB017 (peginterferon beta-1a); Drug: Interferon beta type 1a

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1199
      • Hospital Italiano de Buenos Aires
• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Children's Hospital
• Belgium
  • East Flanders
    • Ghent, East Flanders, Belgium, 9000
      • Universitair Ziekenhuis Ghent
  • Wallonia
    • Liège, Wallonia, Belgium, 4000
      • Clinique CHC MontLégia
• Bulgaria
  • Sofia, Bulgaria, 1113
    • MHATNP 'Sv.Naum', EAD
• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Children's Hospital Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center 'Sestre Milosrdnice'
  • Dalmatia
    • Split, Dalmatia, Croatia, 21000
      • University Hospital Centre Split
• Czechia
  • Hradec Králové, Czechia, 50333
    • Fakultni nemocnice Hradec Kralove
• France
  • Bas Rhin
    • Strasbourg, Bas Rhin, France, 67098
      • CHU Strasbourg - Hôpital Hautepierre
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31059
      • Hopital Purpan
  • Herault
    • Montpellier, Herault, France, 34295
      • Hopital Gui de Chauliac
  • Nord
    • Lille, Nord, France, 59037
      • Hopital Roger Salengro - CHU Lille
  • Val De Marne
    • Le Kremlin-Bicêtre, Val De Marne, France, 94275
      • Hôpital Bicêtre
• Germany
  • Berlin, Germany, 13353
    • Charité - Campus Virchow-Klinikum
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Universitaetsklinikum Freiburg
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Universitaetsmedizin Goettingen
  • North Rhine-Westphalia
    • Bochum, North Rhine-Westphalia, Germany, 44791
      • St. Josef-Hospital Universitaetsklinikum
• Greece
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki 'Hippokration'
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • General Hospital of Larissa
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Baranya
    • Pécs, Baranya, Hungary, 7623
      • Pecsi Tudomanyegyetem KK
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem
• Israel
  • Levant
    • Jerusalem, Levant, Israel, 9112001
      • Hadassah University Hospital - Ein Kerem
  • Tel Aviv
    • Petach-Tikva, Tel Aviv, Israel, 4920235
      • Schneider Children's Medical Center
• Italy
  • Florence, Italy, 50139
    • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
  • Napoli, Italy, 80138
    • Azienda Ospedaliera Universitaria- Università Degli Studi Della Campania "Luigi Vanvitelli"
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria 'Federico II'
• Kuwait
  • Shuwaikh
    • Ash Shuwaykh, Shuwaikh, Kuwait, 12345
      • Ibn Sina Hospital
• Portugal
  • Coimbra, Portugal, 3000-602
    • Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Do Porto, E.P.E. - Hospital de Santo António
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1649-035
      • Centro Hospitalar e Universitário Lisboa Norte E.P.E.
    • Loures, Lisbon District, Portugal, 2674-514
      • Hospital Beatriz Ângelo
  • Minho
    • Braga, Minho, Portugal, 4710-243
      • Hospital de Braga
• Russia
  • Belgorod, Russia, 308007
    • RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'
  • Moscow, Russia, 119602
    • SBHI
  • Moscow, Russia, 129110
    • SBIH of Moscow region "Moscow Regional Scientific & Research
  • Rostov-on-Don, Russia, 344022
    • SBEI HPE 'Rostov State Medical University' of the MoH of the RF
  • Yaroslavl, Russia, 150000
    • State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'
  • Bashkortostan Republic
    • Ufa, Bashkortostan Republic, Russia, 450077
      • SBEI HPE 'Bashkir State Medical University' of the MoH of the RF
  • Krasnoyarsk Krai
    • Krasnoyarsk, Krasnoyarsk Krai, Russia, 660037
      • FSBI "Federal Siberian Scientific-Clinical Center of FMBA"
  • Oblast
    • Tomsk, Oblast, Russia, 634009
      • Nebbiolo LLC
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197110
      • LLC National center for socially significan disease
  • Siberia
    • Kemerovo, Siberia, Russia, 650066
      • SAIH 'Kemerovo Regional Clinical Hospital'
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11461
    • King Saud University
  • Mecca Region
    • Jeddah, Mecca Region, Saudi Arabia, 40047
      • King Faisal Specialist Hospital & Research Center
• Serbia
  • Balkans
    • Belgrade, Balkans, Serbia, 11000
      • Clinic of Neurology and Psychiatry for Children and Youth
    • Belgrade, Balkans, Serbia, 11000
      • University Children Hospital
    • Belgrade, Balkans, Serbia, 11070
      • Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic''
• Slovakia
  • Bratislava, Slovakia, 83340
    • Narodny ustav detskych chorob
• Spain
  • Córdoba, Spain, 14011
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Universitario Virgen de La Arrixaca
• Tunisia
  • Monastir, Tunisia, 5000
    • Hôpital Fattouma Bourghiba
  • Sfax, Tunisia, 3029
    • Hôpital Habib Bourguiba
  • Mannouba
    • Manouba, Mannouba, Tunisia, 2010
      • Hopital Razi
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06500
    • Gazi University Medical Faculty Clinical Research Unit
  • Antalya, Turkey (Türkiye), 07059
    • Akdeniz University Medical Faculty
  • Izmir, Turkey (Türkiye), 35210
    • Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayis Univ. Med. Fac.
• United States
  • California
    • La Jolla, California, United States, 92024
      • UC San Diego Health
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Meridian Clinical Research

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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. Eligible 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 Names: 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. Eligible 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 Names: Avonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Annualized Relapse Rate (ARR) at 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.	Week 48
Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Treatment Discontinuation	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.	From Week 96 to Week 196

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		Weeks 24, 48, and 96
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		Weeks 24, 48, and 96
Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96		Weeks 24, 48, and 96
Part 1: Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96		Weeks 24, 48, and 96
Part 1: Time to First Relapse		Up to Week 96
Part 1: Area Under the Plasma Concentration-Time Curve from Time Zero to End of Dosing Interval (AUCtau) for BIIB017		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
Part 1: Maximum Observed Plasma Concentration (Cmax) at Steady State for BIIB017		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
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State for BIIB017		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
Part 1: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation	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.	Up to Week 100
Part 1: Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN β-1a) [All Participants]	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.	Up to Week 96
Part 1: Number of Participants With Binding Antibodies to Peginterferon (PEG) [BIIB017-Treated Participants]	Anti-PEG binding antibodies in human serum will be determined using an ELISA.	Up to Week 96
Part 2: ARR at 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.	Weeks 144 and 192
Part 2: Number of Participants With Binding and Neutralizing Antibodies to IFN β-1a (All Participants)	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.	Up to Week 192
Part 2: Number of Participants With Binding Antibodies to PEG (BIIB017-Treated Participants)	Anti-PEG binding antibodies in human serum will be determined using an ELISA.	Up to Week 192
Part 1: ARR at Week 96	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.	Week 96
Part 1: Percentage of Participants Free of Relapse at Weeks 48 and 96		Weeks 48 and 96
Part 1: Change from Baseline in Cognition at Weeks 24, 48, 72, and 96 as Measured by the Symbol Digit Modality Test (SDMT)	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.	Baseline, Weeks 24, 48, 72, and 96
Part 1: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at 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).	Baseline, Weeks 48, and 96
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 and 96	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.	Baseline, Weeks 24, 48, 72 and 96
Part 1: Change from Baseline in Height at Weeks 24, 48, 72, 96, and 100		Baseline, Weeks 24, 48, 72, 96, and 100
Part 1: Change from Baseline in Weight at Weeks 24, 48, 72, 96, and 100		Baseline, Weeks 24, 48, 72, 96, and 100
Part 1: Change from Baseline in Tanner Score at 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.	Baseline, Weeks 24, 48, 72, 96, and 100
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	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.	Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, and 100
Part 1: Change from Baseline in Blood Pressure at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100		Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
Part 1: Change from Baseline in Pulse Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100		Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
Part 1: Change from Baseline in Body Temperature at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100		Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
Part 1: Change from Baseline in Respiratory Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100		Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
Part 1: Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Weeks 48, 96, and 100		Baseline (Before dosing), Weeks 48, 96, and 100
Part 1: Percentage of Participants with Changes Over Time in Clinical Laboratory Values	Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.	Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
Part 2: Change from Baseline in EDSS Score at 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).	Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in Height at Weeks 120, 144, 168, 192, and 196		Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in Weight at Weeks 120, 144, 168, 192, and 196		Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in Tanner Score at 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.	Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in Blood Pressure at Weeks 120,144,168, 192, and 196		Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in Pulse Rate at Weeks 120, 144, 168, 192, and 196		Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in Body Temperature at Weeks 120, 144, 168, 192, and 196		Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in Respiratory Rate at Weeks 120, 144, 168, 192, and 196		Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
Part 2: Change from Baseline in 12-Lead ECG Parameters at Weeks 144, 192, and 196		Baseline (Week 96), Weeks 144, 192, and 196
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	MINI-KID is a structured diagnostic interview instrument for psychiatric evaluation and outcome tracking. All questions are answered Yes or No.	Baseline (Week 96), Weeks 108, 120, 132, 144,156, 168, 180, 192, and 196
Part 2: Percentage of Participants with Changes Over Time in Clinical Laboratory Values	Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.	Baseline (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192, and 196

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Intercellular Signaling Peptides and Proteins; Cytokines; Interferon Type I; Interferons; Interferon-beta; Interferon beta-1a; peginterferon beta-1a
• Other Study ID Numbers: 105MS306; 2018-003008-38 (EudraCT Number); 2023-505624-56 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No