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    Summary
    EudraCT Number:2019-002663-10
    Sponsor's Protocol Code Number:232SM203
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-05
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-002663-10
    A.3Full title of the trial
    Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
    A nuszinerszen (BIIB058) készítmény dóziseszkalációs és randomizált, kontrollált vizsgálata spinális muszkuláris atrófiában szenvedő betegek esetében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
    A.3.2Name or abbreviated title of the trial where available
    Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
    A.4.1Sponsor's protocol code number232SM203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04089566
    A.5.4Other Identifiers
    Name:INDNumber:110011
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    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 pointMedical Director
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    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 Spinraza
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/12/976
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNusinersen
    D.3.9.1CAS number 125894-36-9
    D.3.9.2Current sponsor codeISIS 396443 (BIIB058)
    D.3.9.3Other descriptive nameNUSINERSEN SODIUM
    D.3.9.4EV Substance CodeSUB189898
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product type2′-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide
    D.IMP: 2
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/12/976
    D.3 Description of the IMP
    D.3.1Product nameNusinersen
    D.3.2Product code ISIS 396443, BIIB058
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNUSINERSEN
    D.3.9.1CAS number 125894-36-9
    D.3.9.2Current sponsor codeISIS 396443 (BIIB058)
    D.3.9.3Other descriptive nameNUSINERSEN SODIUM
    D.3.9.4EV Substance CodeSUB189898
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product type2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide
    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
    Muscular Atrophy, Spinal
    E.1.1.1Medical condition in easily understood language
    Spinal Muscular Atrophy (SMA)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10041582
    E.1.2Term Spinal muscular atrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) (Parts A and C); to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA, as measured by change in CHOP
    INTEND total score (Part B).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the pharmacokinetic(s) PK of nusinersen [cerebrospinal fluid (CSF) and plasma] after intrathecal administration of nusinersen given at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants
    with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants
    with SMA (Part B).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A, B and C: - Genetic documentation of 5q SMA (homozygous gene deletion, mutation, or compound heterozygote)

    Part A:
    - Onset of clinical signs and symptoms consistent with SMA at > 6 months (> 180 days) of age (i.e., later-onset SMA)
    - Age 2 to 15 years, inclusive, at the time of informed consent

    Part B:
    - Participants with SMA symptom onset ≤ 6 months (≤ 180 days) of age (infantile onset) should have age ≤ 7 months (≤ 210 days) at the time of informed consent
    - Participants with SMA symptom onset > 6 months (> 180 days) of age (later onset):
    - Age 2 to < 10 years at the time of informed consent
    - Can sit independently but has never had the ability to walk independently
    - HFMSE score ≥ 10 and ≤ 54 at Screening

    Part C:
    - Participants ≥ 18 years of age at Screening must be ambulatory
    - Currently on nusinersen treatment at the time of Screening, with the first dose being at least 1 year prior to Screening
    E.4Principal exclusion criteria
    Part A, B and C:
    - Presence of an untreated or inadequately treated active infection requiring systemic antiviral or antimicrobial therapy at any time during the Screening period
    - Presence of an implanted shunt for the drainage of CSF or of an implanted central nervous system (CNS) catheter
    - Hospitalization for surgery, pulmonary event, or nutritional support within 2 months prior to Screening or planned within 12 months after the participant’s first dose
    - Dosing with onasemnogene abeparvovec-xioi (Zolgensma) within 6 months prior to Screening

    Part A:
    - Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period, at Screening
    - Medical necessity for a gastric feeding tube
    - Treatment with an investigational drug given for the treatment of SMA, biological agent, or device within 30 days prior to Screening or anytime during the study; prior treatment with risdiplam or branaplam; or any history of gene therapy, prior antisense oligonucleotide treatment, or cell transplantation

    Part B:
    - Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period, at Screening
    - Medical necessity for a gastric feeding tube
    - Treatment with an investigational drug given for the treatment of SMA, biological agent, or device within 30 days prior to Screening or anytime during the study; prior treatment with risdiplam or branaplam; or any history of gene therapy, prior antisense oligonucleotide treatment, or cell transplantation

    Part C:
    - Concurrent participation and/or administration of nusinersen in another clinical study

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    Part B Infantile-onset SMA:

    1) Change from Baseline in Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) Total Score

    Part A and C:
    2) Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    3) Number of Participants with Clinically Significant Shifts from Baseline in Clinical Laboratory Parameters
    4) Number of Participants with Clinically Significant Shifts from Baseline in Electrocardiograms (ECGs)
    5) Number of Participants with Clinically Significant Shifts from Baseline in Vital Signs
    6) Change from Baseline in Body Length/Height

    Part C Infantile-onset SMA:
    7) Change from Baseline in Head Circumference
    8) Change from Baseline in Chest Circumference
    9) Change from Baseline in Arm Circumference

    Part A and C Later-onset SMA:
    10) Change from Baseline in Ulnar Length

    Part A and C:
    11) Ratio of Weight for Age
    12) Ratio of Weight for Length

    Part C:
    13) Ratio of Head-to-chest Circumference

    Part A and C:
    14) Change from Baseline in Activated Partial Thromboplastin Time (aPTT)
    15) Change from Baseline in Prothrombin Time (PT)
    16) Change from Baseline in International Normalized Ratio (INR)
    17) Change in Urine Total Protein
    18) Change from Baseline in Neurological Examination Outcomes
    19) Percentage of Participants with a Postbaseline Platelet Count Below the Lower Limit of Normal on at least 2 Consecutive Measurements
    20) Percentage of Participants with a Postbaseline Corrected QT Interval Using Fridericia’s Formula (QTcF) of > 500 millisecond (msec) and an Increase from Baseline to Any Postbaseline Timepoint in QTcF of > 60 msec
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part B Infantile-onset SMA:
    1) Baseline up to Day 183

    Part A and C:
    2) Screening up to Day 302
    3) Screening up to Day 302
    4) Screening up to Day 302
    5) Screening up to Day 302
    6) Baseline up to Day 302

    Part C Infantile-onset SMA:
    7) Baseline up to Day 302
    8) Baseline up to Day 302
    9) Baseline up to Day 302

    Part A and C Later-onset SMA:
    10) Baseline up to Day 302

    Part A and C:
    11) Baseline up to Day 302
    12) Baseline up to Day 302

    Part C:
    13) Baseline up to Day 302

    Part A and C:
    14) Baseline up to Day 269
    15) Baseline up to Day 269
    16) Baseline up to Day 269
    17) Baseline up to Day 269
    18) Baseline up to Day 302
    19) Baseline up to Day 302
    20) Baseline up to Day 302
    E.5.2Secondary end point(s)
    Part B Infantile-onset SMA:
    1) Percentage of Hammersmith Infant Neurological Examination (HINE) Section 2 Motor Milestone Responders

    Part B and C Infantile-onset SMA:
    2) Change from Baseline in HINE Section 2 Motor Milestones Total Score

    Part B Infantile-onset SMA:
    3) Time to Permanent Ventilation
    4) Time to Death (Overall Survival)

    Part A, B and C Later-onset SMA:
    5) Change from Baseline in Hammersmith Functional Motor Scale – Expanded (HFMSE) Score
    6) Change from Baseline in Revised Upper Limb Module (RULM) Score
    7) Number of New WHO Motor Milestones Responders
    8) Change from Baseline in Assessment of Caregiver Experience with Neuromuscular Disease (ACEND)
    9) Change from Baseline in Pediatric Quality of Life Inventory™ (PedsQL)

    Part B:
    10) Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    11) Number of Participants with Clinically Significant Shifts from Baseline in Clinical Laboratory Parameters
    12) Number of Participants with Clinically Significant Shifts from Baseline in Electrocardiograms (ECGs)
    13) Number of Participants with Clinically Significant Shifts from Baseline in Vital Signs
    14) Change from Baseline in body length/height

    Part B Infantile-onset SMA:
    15) Change from Baseline in Head Circumference
    16) Change from Baseline in Chest Circumference
    17) Change from Baseline in Arm Circumference

    Part B Later-onset SMA:
    18) Change from baseline in Ulnar Length

    Part B:
    19) Ratio of Weight for Age
    20) Ratio of Weight for Length
    21) Ratio of Head-to-chest Circumference
    22) Change from Baseline in aPTT
    23) Change from Baseline in PT
    24) Change from Baseline in INR
    25) Change in Urine Total Protein
    26) Change from Baseline in Neurological Examination Outcomes
    27) Percentage of Participants with a Postbaseline Platelet Count Below the Lower Limit of Normal on at least 2 Consecutive Measurements
    28) Percentage of Participants with a Postbaseline QTcF of > 500 millisecond (msec) and an Increase from Baseline to Any Postbaseline Timepoint in QTcF of > 60 msec

    Part A, B and C:
    29) Number of Hospitalizations
    30) Duration of Hospitalizations
    31) Clinical Global Impression of Change (CGIC)
    32) Number of Participants with Serious Respiratory Events

    Part B Infantile-onset SMA:
    33) Percentage of Time on Ventilation

    Part C Infantile-onset SMA:
    34) Ventilator Use
    Part A and B:
    35) Change from Baseline in the Parent Assessment of Swallowing Ability (PASA) Scale

    Part A B and C:
    36) Cerebrospinal Fluid (CSF) Levels of Nusinersen
    37) Plasma Levels of Nusinersen

    Part C Infantile-onset SMA:
    38) Change from Baseline in CHOP INTEND Total Score

    Part C Later-onset SMA:
    39) Change from Baseline in 6-Minute Walk Test (6MWT) Distance
    40) Change from Baseline in 10-Meter Walk/Run Test (10MWR)
    41) Change from Baseline in Spinal Muscular Atrophy-Health Index (SMA-HI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Day 302

    2) Baseline up to Day 302

    3) and 4) Screening up to Day 302

    5) to 9) - Baseline up to Day 302

    10) and 11) Screening up to Day 302
    12) Day 1 up to Day 302
    13) Screening up to Day 302
    14) Baseline up to Day 302

    15) to 17) Baseline up to Day 302

    18) Baseline up to Day 302

    19) to 21) Baseline up to Day 302
    22) to 25) Baseline up to Day 279
    26) to 28) Baseline up to Day 302

    29) and 30) Day 1 to Day 279
    31) Day 302
    32) Screening up to Day 302

    33) Screening up to Day 302

    34) Screening up to Day 302

    35) Baseline up to Day 302

    36) Baseline up to Day 279
    37) Baseline up to Day 302

    38) Baseline to up Day 302

    39) to 41) Baseline up to Day 302
    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) Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Sequential Assignment: Part A - Open Label. Part B - Double Blind. Part C - Open Label
    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
    Part B only - commercial Spinraza
    E.8.2.4Number of treatment arms in the trial4
    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 EEA24
    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
    Brazil
    Canada
    Chile
    Colombia
    Estonia
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Latvia
    Lebanon
    Mexico
    Poland
    Russian Federation
    Saudi Arabia
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 132
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 108
    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: 12
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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)
    in addition to standard of care, subjects may be able to enter an extension study.
    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 Decision2020-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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