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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03958877




Registration number
NCT03958877
Ethics application status
Date submitted
20/05/2019
Date registered
22/05/2019
Date last updated
18/06/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2018-003008-38
Secondary ID [2] 0 0
105MS306
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIIB017 (peginterferon beta-1a)
Treatment: Drugs - Interferon beta type 1a

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.

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.


Treatment: Drugs: BIIB017 (peginterferon beta-1a)
Administered as specified in the treatment arm

Treatment: Drugs: Interferon beta type 1a
Administered as specified in the treatment arm

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Annualized Relapse Rate (ARR) at 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.
Timepoint [1] 0 0
Week 96
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
From Week 96 to Week 196
Secondary outcome [1] 0 0
Part 1: ARR at 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.
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Weeks 24, 48, and 96
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Weeks 24, 48, and 96
Secondary outcome [4] 0 0
Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96
Timepoint [4] 0 0
Weeks 24, 48, and 96
Secondary outcome [5] 0 0
Part 1: Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96
Timepoint [5] 0 0
Weeks 24, 48, and 96
Secondary outcome [6] 0 0
Part 1: Time to First Relapse
Timepoint [6] 0 0
Up to Week 96
Secondary outcome [7] 0 0
Part 1: Percentage of Participants Free of Relapse Up to Week 96
Timepoint [7] 0 0
Up to Week 96
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline, Weeks 24, 48, 72 and 96
Secondary outcome [9] 0 0
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).
Timepoint [9] 0 0
Baseline, Weeks 48 and 96
Secondary outcome [10] 0 0
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 - 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.
Timepoint [10] 0 0
Baseline, Weeks 24, 48, 72, 96 and 100
Secondary outcome [11] 0 0
Part 1: Area Under the Plasma Concentration-Time Curve from Time Zero to End of Dosing Interval (AUCtau) for BIIB017
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Part 1: Maximum Observed Plasma Concentration (Cmax) at Steady State for BIIB017
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State for BIIB017
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Up to Week 100
Secondary outcome [15] 0 0
Part 1: Change from Baseline in Height at Weeks 24, 48, 72, 96 and 100
Timepoint [15] 0 0
Baseline, Weeks 24, 48, 72, 96 and 100
Secondary outcome [16] 0 0
Part 1: Change from Baseline in Weight at Weeks 24, 48, 72, 96 and 100
Timepoint [16] 0 0
Baseline, Weeks 24, 48, 72, 96 and 100
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
Baseline, Weeks 24, 48, 72, 96 and 100
Secondary outcome [18] 0 0
Part 1: Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN ß-1a) [All Participants] - Presence of IFN ß-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.
Timepoint [18] 0 0
Up to Week 96
Secondary outcome [19] 0 0
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.
Timepoint [19] 0 0
Up to Week 96
Secondary outcome [20] 0 0
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.
Timepoint [20] 0 0
Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96 and 100
Secondary outcome [21] 0 0
Part 1: Change from Baseline in Blood Pressure at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100
Timepoint [21] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100
Secondary outcome [22] 0 0
Part 1: Change from Baseline in Heart Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100
Timepoint [22] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100
Secondary outcome [23] 0 0
Part 1: Change from Baseline in Body Temperature at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100
Timepoint [23] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100
Secondary outcome [24] 0 0
Part 1: Change from Baseline in Respiratory Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100
Timepoint [24] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84,96 and 100
Secondary outcome [25] 0 0
Part 1: Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Weeks 48, 96 and 100
Timepoint [25] 0 0
Baseline (Before dosing), Weeks 48, 96 and 100
Secondary outcome [26] 0 0
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.
Timepoint [26] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100
Secondary outcome [27] 0 0
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.
Timepoint [27] 0 0
Weeks 144 and 192
Secondary outcome [28] 0 0
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).
Timepoint [28] 0 0
Baseline (Week 96), Weeks 120, 144, 168, 192 and 196
Secondary outcome [29] 0 0
Part 2: Change from Baseline in Height at Weeks 120, 144, 168, 192 and 196
Timepoint [29] 0 0
Baseline (Week 96), Weeks 120, 144, 168, 192 and 196
Secondary outcome [30] 0 0
Part 2: Change from Baseline in Weight at Weeks 120, 144, 168, 192 and 196
Timepoint [30] 0 0
Baseline (Week 96), Weeks 120, 144, 168, 192 and 196
Secondary outcome [31] 0 0
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.
Timepoint [31] 0 0
Baseline (Week 96), Weeks 120, 144, 168, 192 and 196
Secondary outcome [32] 0 0
Part 2: Number of Participants With Binding and Neutralizing Antibodies to IFN ß-1a (All Participants) - Presence of IFN ß-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.
Timepoint [32] 0 0
Up to Week 192
Secondary outcome [33] 0 0
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.
Timepoint [33] 0 0
Up to Week 192
Secondary outcome [34] 0 0
Part 2: Change from Baseline in Blood Pressure at Weeks 120,144,168,192 and 196
Timepoint [34] 0 0
Baseline (Week 96), Weeks 120, 144, 168, 192 and 196
Secondary outcome [35] 0 0
Part 2: Change from Baseline in Heart Rate at Weeks 120, 144, 168, 192 and 196
Timepoint [35] 0 0
Baseline (Week 96), Weeks 120, 144, 168, 192 and 196
Secondary outcome [36] 0 0
Part 2: Change from Baseline in Body Temperature at Weeks 120, 144, 168, 192 and 196
Timepoint [36] 0 0
Baseline (Week 96), Weeks 120, 144, 168, 192 and 196
Secondary outcome [37] 0 0
Part 2: Change from Baseline in Respiratory Rate at Weeks 120, 144, 168, 192 and 196
Timepoint [37] 0 0
Baseline (Week 96), Weeks 120, 144, 168, 192 and 196
Secondary outcome [38] 0 0
Part 2: Change from Baseline in 12-Lead ECG Parameters at Weeks 144, 192 and 196
Timepoint [38] 0 0
Baseline (Week 96), Weeks 144, 192 and 196
Secondary outcome [39] 0 0
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.
Timepoint [39] 0 0
Baseline (Week 96), Weeks 108, 120, 132, 144,156, 168, 180, 192 and 196
Secondary outcome [40] 0 0
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.
Timepoint [40] 0 0
Baseline (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192 and 196

Eligibility
Key inclusion criteria
Key

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
Minimum age
10 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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 ß-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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad Autonoma Buenos Aires
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Liege
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sofia
Country [9] 0 0
Croatia
State/province [9] 0 0
Split
Country [10] 0 0
Croatia
State/province [10] 0 0
Zagreb
Country [11] 0 0
Czechia
State/province [11] 0 0
Hradec Kralove
Country [12] 0 0
France
State/province [12] 0 0
Bas Rhin
Country [13] 0 0
France
State/province [13] 0 0
Haute Garonne
Country [14] 0 0
France
State/province [14] 0 0
Herault
Country [15] 0 0
France
State/province [15] 0 0
Nord
Country [16] 0 0
France
State/province [16] 0 0
Val De Marne
Country [17] 0 0
Germany
State/province [17] 0 0
Baden Wuerttemberg
Country [18] 0 0
Germany
State/province [18] 0 0
Niedersachsen
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein Westfalen
Country [20] 0 0
Greece
State/province [20] 0 0
Larissa
Country [21] 0 0
Greece
State/province [21] 0 0
Marousi
Country [22] 0 0
Greece
State/province [22] 0 0
Thessaloniki
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Hungary
State/province [24] 0 0
Pecs
Country [25] 0 0
Israel
State/province [25] 0 0
Jerusalem
Country [26] 0 0
Israel
State/province [26] 0 0
Petach-Tikva
Country [27] 0 0
Italy
State/province [27] 0 0
Firenze
Country [28] 0 0
Italy
State/province [28] 0 0
Napoli
Country [29] 0 0
Kuwait
State/province [29] 0 0
Shuwaikh
Country [30] 0 0
Portugal
State/province [30] 0 0
Braga
Country [31] 0 0
Portugal
State/province [31] 0 0
Coimbra
Country [32] 0 0
Portugal
State/province [32] 0 0
Lisboa
Country [33] 0 0
Portugal
State/province [33] 0 0
Loures
Country [34] 0 0
Portugal
State/province [34] 0 0
Porto
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Belgorod
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Kemerovo
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Krasnoyarsk
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow
Country [39] 0 0
Russian Federation
State/province [39] 0 0
St. Petersburg
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Yaroslavl
Country [41] 0 0
Saudi Arabia
State/province [41] 0 0
Jeddah
Country [42] 0 0
Saudi Arabia
State/province [42] 0 0
Riyadh
Country [43] 0 0
Serbia
State/province [43] 0 0
Belgrade
Country [44] 0 0
Slovakia
State/province [44] 0 0
Bratislava
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Murcia
Country [47] 0 0
Spain
State/province [47] 0 0
Cordoba
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Tunisia
State/province [49] 0 0
Mannouba
Country [50] 0 0
Tunisia
State/province [50] 0 0
Monastir
Country [51] 0 0
Tunisia
State/province [51] 0 0
Sfax
Country [52] 0 0
Turkey
State/province [52] 0 0
Ankara
Country [53] 0 0
Turkey
State/province [53] 0 0
Antalya
Country [54] 0 0
Turkey
State/province [54] 0 0
Izmir
Country [55] 0 0
Turkey
State/province [55] 0 0
Samsun

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03958877
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US Biogen Clinical Trial Center
Address 0 0
Country 0 0
Phone 0 0
866-633-4636
Fax 0 0
Email 0 0
clinicaltrials@biogen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03958877