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Active, not recruitingNCT03958877Updated Sep 24, 2026

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

A Phase 3 interventional study of BIIB017 (peginterferon beta-1a) and Interferon beta type 1a in Multiple Sclerosis, Relapsing-Remitting, sponsored by Biogen. Active, not recruiting at 65 sites in 22 countries. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Biogen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting
03

In context

Multiple Sclerosis, Relapsing-Remitting

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.

This study's enrollment of 152 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.

Browse Biogen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 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 .
  • 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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
152 participants (actual)

Study arms

  • 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)

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 48

  2. 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.

    Time frame: From Week 96 to Week 196

Secondary outcomes

  1. 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.

    Time frame: Week 96

  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 at Weeks 48 and 96

    Time frame: Weeks 48 and 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)

    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.

    Time frame: Baseline, Weeks 24, 48, 72, and 96

  9. 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).

    Time frame: Baseline, Weeks 48, and 96

  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 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.

    Time frame: Baseline, Weeks 24, 48, 72 and 96

  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

    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.

    Time frame: Up to Week 100

  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

    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.

    Time frame: Baseline, Weeks 24, 48, 72, 96, and 100

  18. 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.

    Time frame: Up to Week 96

  19. 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.

    Time frame: Up to Week 96

  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

    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.

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, and 100

  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 Pulse 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

    Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.

    Time frame: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100

  27. 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.

    Time frame: Weeks 144 and 192

  28. 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).

    Time frame: Baseline (Week 96), Weeks 120, 144, 168, 192, and 196

  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

    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.

    Time frame: Baseline (Week 96), Weeks 120, 144, 168, 192, and 196

  32. 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.

    Time frame: Up to Week 192

  33. 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.

    Time frame: Up to Week 192

  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 Pulse 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

    MINI-KID is a structured diagnostic interview instrument for psychiatric evaluation and outcome tracking. All questions are answered Yes or No.

    Time frame: Baseline (Week 96), Weeks 108, 120, 132, 144,156, 168, 180, 192, and 196

  40. 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.

    Time frame: Baseline (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192, and 196

07

Study locations

65 sites
08

References and documents

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03958877
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
May 22, 2019
Start date
Oct 18, 2019
Primary completion
May 20, 2027 (estimated)
Completion
May 20, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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