Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35918   clinical trials with a EudraCT protocol, of which   5893   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-003008-38
    Sponsor's Protocol Code Number:105MS306
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2018-003008-38
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.4.1Sponsor's protocol code number105MS306
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/127/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact point105MS306 Clinical Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressInnovation house, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailclinicaltrials@biogen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Plegridy
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePEGylated Interferon Beta-1a
    D.3.2Product code BIIB017
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON BETA-1A
    D.3.9.1CAS number 1211327-92-2
    D.3.9.2Current sponsor codeBIIB017
    D.3.9.3Other descriptive namePEGINTERFERON BETA-1A
    D.3.9.4EV Substance CodeSUB121165
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeInterferon Beta-1a
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name AVONEX®
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameinterferon beta-1α
    D.3.2Product code IFN β-1a
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInterferon Beta-1a
    D.3.9.1CAS number 220581-49-7
    D.3.9.3Other descriptive nameInterferon Beta-1a
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Remitting Multiple Sclerosis (RRMS)
    E.1.1.1Medical condition in easily understood language
    multiple sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1- To evaluate the safety, tolerability, and descriptive efficacy of
    BIIB017 in pediatric subjects with RRMS
    -  To assess the PK of BIIB017 in pediatric subjects with RRMS
    The primary objective of Part 2 of the study is to evaluate the longterm
    safety of BIIB017 in subjects who completed the study treatment
    at Week 96 in Part 1 of the study.
    E.2.2Secondary objectives of the trial
    The secondary objective of Part 2 of the study is to further describe
    safety and the long-term MS outcomes after BIIB017 treatment in
    subjects who completed the study treatment at Week 96 in Part 1 of the
    study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1
    1. Ability of parents or legal guardians to understand the purpose and risks of the study and
    provide signed and dated informed consent and authorization to use confidential health
    information in accordance with national and local subject privacy regulations. Subjects
    will provide assent in addition to the parent’s or guardian’s consent, as appropriate, per
    local regulations.
    2. Age 10 to <18 years old at the time of informed consent. The minimum age can be older
    than 10 years, as required by country-specific regulations and/or local ethics committees.
    3. Must have a diagnosis of RRMS as defined by the revised consensus definition for
    pediatric MS [Krupp 2013; Polman 2011].
    4. Must have an EDSS score between 0.0 and 5.5.
    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). Relapse is defined as the occurrence of a clinical
    demyelination event regardless of whether the event is a first (initial) or subsequent
    (recurrent) demyelinating event.
    6. Female subjects of childbearing potential and all male subjects must practice effective
    contraception during the study and for 3 months after their last dose of study treatment,
    unless they agree to abstinence. For further details of contraceptive requirements for this
    study, see Section 15.5.
    Part 2
    1. Subjects who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.
    2. Sexually active subjects of childbearing potential must continue to practice effective
    contraception during the study and for 3 months after their last dose of study treatment.
    E.4Principal exclusion criteria
    PART 1
    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. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing subjects by the lack of clinically stable periods or clinical improvement.
    2. History of seizure disorder or unexplained blackouts, or history of a seizure within 3 months prior to randomization (Day 1).
    3. History of suicidal ideation within 3 months prior to randomization (Day 1) or an episode of severe depression within 3 months prior to randomization (Day 1). Severe depression is defined as an episode of depression that requires hospitalization or is otherwise regarded as severe by the Investigator.
    4. Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization (Day 1).
    5. History of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator that would preclude participation in the study.
    6. Abnormal screening blood tests exceeding any of the following defined limits:
    a. ALT >2 upper limit of normal (ULN)
    b. AST >2 ULN
    c. Gamma-glutamyl transferase (GGT) >2 ULN
    d. Total bilirubin >1.5 ULN
    e. Total WBC count <3700/mm3
    • ANC 1500/mm3
    f. Platelet count <150,000/mm3
    g. Hemoglobin <10 g/dL in female subjects or <11 g/dL in male subjects
    h. Serum creatinine >1 ULN
    i. Prothrombin time or activated partial thromboplastin time >1.2 ULN

    PART 2
    1. 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 subject’s participation in Part 1.
    The Investigator must re-assess the subject’s medical fitness for participation and consider any factors that would preclude treatment.
    2. The subject could not tolerate BIIB017 in Part 1.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1- The primary endpoint is the annualized relapse rate (ARR) at Week 96.
    Part 2- The primary endpoint is the safety and tolerability of BIIB017 as
    assessed by the incidence of AEs, SAEs, and AEs leading to study
    treatment discontinuation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1 - week 96
    E.5.2Secondary end point(s)
    PART 1:
    The secondary endpoints related to efficacy:
    • ARR at Week 48
    • Proportion of subjects free of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans at Weeks 24, 48, and 96
    • Proportion of subjects 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
    The secondary endpoints related to safety, tolerability, and PK are as follows:
    • Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation
    • Change over time in growth parameters, including height, weight, and Tanner Score
    PART 2
    The secondary endpoints are as follows:
    • ARR at Weeks 144 and 192
    • Change from baseline in EDSS
    • Change over time in growth parameters, including height, weight, and Tanner Score
    • Immunogenicity as assessed by the development of binding and neutralizing antibodies to IFN β-1a and/or binding antibodies to PEG
    • Change from baseline in vital signs, 12-lead ECG parameters, and depression as assessed by MINI-KID
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1 - Week 48
    Part 2 - Weeks 144 and 192
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Avonex
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Bulgaria
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Kuwait
    Mexico
    Portugal
    Russian Federation
    Saudi Arabia
    Serbia
    Slovakia
    Spain
    Tunisia
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is last subject, last visit for final collection of data.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 142
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 122
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 142
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-17
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA