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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003008-38 | EudraCT Number | ||
| 2023-505624-56 | Other Identifier | EU CTIS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB017 (peginterferon beta-1a) | Experimental | 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. |
|
| Avonex | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB017 (peginterferon beta-1a) | Drug | Administered as specified in the treatment arm |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Part 1:
Part 2:
• Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.
Key Exclusion Criteria:
Part 1:
Part 2:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Health | La Jolla | California | 92024 | United States | ||
| UNC Hospitals |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Interferon beta type 1a | Drug | Administered as specified in the treatment arm |
|
|
| 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: 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: 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: 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: 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 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: 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: 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: 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 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 |
| Chapel Hill |
| North Carolina |
| 27514 |
| United States |
| Meridian Clinical Research | Norfolk | Virginia | 23502 | United States |
| Hospital Italiano de Buenos Aires | Ciudad Autonoma Buenos Aires | Buenos Aires | 1199 | Argentina |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Universitair Ziekenhuis Ghent | Ghent | East Flanders | 9000 | Belgium |
| Clinique CHC MontLégia | Liège | Wallonia | 4000 | Belgium |
| MHATNP 'Sv.Naum', EAD | Sofia | 1113 | Bulgaria |
| University Hospital Centre Split | Split | Dalmatia | 21000 | Croatia |
| Children's Hospital Zagreb | Zagreb | 10000 | Croatia |
| Clinical Hospital Center 'Sestre Milosrdnice' | Zagreb | 10000 | Croatia |
| University Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 50333 | Czechia |
| CHU Strasbourg - Hôpital Hautepierre | Strasbourg | Bas Rhin | 67098 | France |
| Hopital Purpan | Toulouse | Haute Garonne | 31059 | France |
| Hopital Gui de Chauliac | Montpellier | Herault | 34295 | France |
| Hopital Roger Salengro - CHU Lille | Lille | Nord | 59037 | France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | Val De Marne | 94275 | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitaetsmedizin Goettingen | Göttingen | Lower Saxony | 37075 | Germany |
| St. Josef-Hospital Universitaetsklinikum | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Charité - Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| General Hospital of Larissa | Larissa | Thessaly | 41110 | Greece |
| General Hospital of Thessaloniki 'Hippokration' | Thessaloniki | 54642 | Greece |
| Pecsi Tudomanyegyetem KK | Pécs | Baranya | 7623 | Hungary |
| Debreceni Egyetem | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Hadassah University Hospital - Ein Kerem | Jerusalem | Levant | 9112001 | Israel |
| Schneider Children's Medical Center | Petach-Tikva | Tel Aviv | 4920235 | Israel |
| Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer | Florence | 50139 | Italy |
| Azienda Ospedaliera Universitaria 'Federico II' | Naples | 80131 | Italy |
| Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" | Naples | 80138 | Italy |
| Ibn Sina Hospital | Ash Shuwaykh | Shuwaikh | 12345 | Kuwait |
| Centro Hospitalar e Universitário Lisboa Norte E.P.E. | Lisbon | Lisbon District | 1649-035 | Portugal |
| Hospital Beatriz Ângelo | Loures | Lisbon District | 2674-514 | Portugal |
| Hospital de Braga | Braga | Minho | 4710-243 | Portugal |
| Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico | Coimbra | 3000-602 | Portugal |
| Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António | Porto | 4099-001 | Portugal |
| SBEI HPE 'Bashkir State Medical University' of the MoH of the RF | Ufa | Bashkortostan Republic | 450077 | Russia |
| FSBI "Federal Siberian Scientific-Clinical Center of FMBA" | Krasnoyarsk | Krasnoyarsk Krai | 660037 | Russia |
| Nebbiolo LLC | Tomsk | Oblast | 634009 | Russia |
| LLC National center for socially significan disease | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| SAIH 'Kemerovo Regional Clinical Hospital' | Kemerovo | Siberia | 650066 | Russia |
| RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf' | Belgorod | 308007 | Russia |
| SBHI | Moscow | 119602 | Russia |
| SBIH of Moscow region "Moscow Regional Scientific & Research | Moscow | 129110 | Russia |
| SBEI HPE 'Rostov State Medical University' of the MoH of the RF | Rostov-on-Don | 344022 | Russia |
| State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2' | Yaroslavl | 150000 | Russia |
| King Faisal Specialist Hospital & Research Center | Jeddah | Mecca Region | 40047 | Saudi Arabia |
| King Saud University | Riyadh | 11461 | Saudi Arabia |
| Clinic of Neurology and Psychiatry for Children and Youth | Belgrade | Balkans | 11000 | Serbia |
| University Children Hospital | Belgrade | Balkans | 11000 | Serbia |
| Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic'' | Belgrade | Balkans | 11070 | Serbia |
| Narodny ustav detskych chorob | Bratislava | 83340 | Slovakia |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14011 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hopital Razi | Manouba | Mannouba | 2010 | Tunisia |
| Hôpital Fattouma Bourghiba | Monastir | 5000 | Tunisia |
| Hôpital Habib Bourguiba | Sfax | 3029 | Tunisia |
| Gazi University Medical Faculty Clinical Research Unit | Ankara | 06500 | Turkey (Türkiye) |
| Akdeniz University Medical Faculty | Antalya | 07059 | Turkey (Türkiye) |
| Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi | Izmir | 35210 | Turkey (Türkiye) |
| Ondokuz Mayis Univ. Med. Fac. | Samsun | 55139 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C428112 | peginterferon beta-1a |
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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