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    Summary
    EudraCT Number:2013-003752-21
    Sponsor's Protocol Code Number:SA-307JG
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-25
    Trial results View 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 number2013-003752-21
    A.3Full title of the trial
    A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

    Többközpontú, randomizált, a kiindulási kezelést kiegészítő, kettős vak, placebo-kontrollos, III. fázisú vizsgálat az SA237 hatásosságának és biztonságosságának kiértékelésére a neuromyelitis opticában (NMO) és NMO spektrumbetegségben (NMOSD) szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder
    Késő szakaszú klinikai vizsgálat az SA237 hatásosságának és biztonságosságának kiértékelésére a neuromyelitis opticában és neuromyelitis optica spektrumbetegségben szenvedő betegeknél
    A.4.1Sponsor's protocol code numberSA-307JG
    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 SponsorChugai Pharmaceutical Co. Ltd
    B.1.3.4CountryJapan
    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 supportChugai Pharmaceutical Co. Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChugai Pharma Europe Ltd.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressMulliner House, Flanders Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW4 1NN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442089875600
    B.5.5Fax number442089875616
    B.5.6E-mailregulatory@chugai-pharm.co.uk
    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 No
    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.3.2Product code SA237
    D.3.4Pharmaceutical form Solution for injection
    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 INNFully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
    D.3.9.1CAS number Not known
    D.3.9.2Current sponsor codeSA237
    D.3.9.3Other descriptive namefully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
    E.1.1.1Medical condition in easily understood language
    Central Nervous System disorder causing primarily swelling and inflammation of the eye nerves and the spinal cord
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10029322
    E.1.2Term Neuromyelitis optica
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of SA237 compared with placebo in patients with NMO and NMOSD
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet the following criteria for study entry:
    1. Patients must be diagnosed as having either:
    a. NMO as defined by 2006 criteria*, or
    b. NMOSD as defined by either of the following Wingerchuk 2007 criteria with anti-aquaporin 4 antibody (AQP4Ab) seropositive status at screening‡.
    i) Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord magnetic resonance imaging [MRI] lesion)
    ii) Optic neuritis: recurrent or simultaneous bilateral
    For patients aged 12 to 17 years, a minimum of 6 patients should be positive for anti-AQP4Ab status at screening‡.
    ‡ Screening result is based on either the blood sample data collected at screening visit, or the blood sample data collected before the screening visit and measured by Sponsor’s designee for analysis.
    2. Clinical evidence of at least 2 documented relapses (including first attack) in the last 2 years prior to screening, at least one of which has occurred in the 12 months prior to screening.
    3. Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening.
    4. Age 12 to 74 years, inclusive at the time of informed consent.
    5. One of the following baseline treatments for relapse prevention must be at stable dose as a monotherapy for 8 weeks prior to baseline**:
    a. Azathioprine.
    b. Mycophenolate mofetil.
    c. Oral corticosteroids.
    ** For patients aged 12 to 17 years, either of the following baseline treatments for relapse prevention can be allowed:
    d. Azathioprine + oral corticosteroids.
    e. Mycophenolate mofetil + oral corticosteroids.
    6. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol.

    *According to Wingerchuk et al. 2006, a diagnosis of NMO requires all of the following three criteria:
    I. Optic neuritis
    II. Acute myelitis
    III. At least two of three supportive criteria:
    - Contiguous spinal cord lesion identified on an MRI scan extending over 3 vertebral segments
    - Brain MRI not meeting diagnostic criteria for multiple sclerosis
    - NMO-immunoglobulin G seropositive status
    E.4Principal exclusion criteria
    Exclusion criteria related to previous or concomitant therapy:
    1. Any previous treatment with interleukin-6 (IL-6) inhibitory therapy (e.g. tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time.
    2. Any previous treatment with anti-cluster of differentiation (CD) 20, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline.
    3. Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline.
    4. Treatment with any investigational agent within 3 months prior to baseline.
    Exclusions for general safety:
    5. Pregnancy or lactation.
    6. For patients of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [patient or partner], in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug.
    7. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.
    8. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
    9. Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, such as: other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
    10. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
    11. Evidence of chronic active hepatitis B or C.
    12. History of drug or alcohol abuse within 1 year prior to baseline.
    13. History of diverticulitis that, in the Investigator’s opinion, may lead to increased risk of complications such as lower gastrointestinal perforation.
    14. Evidence of active tuberculosis (TB; excluding patients receiving chemoprophylaxis for latent TB infection).
    15. Evidence of active interstitial lung disease.
    16. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline.
    17. History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured).
    18. History of severe allergic reaction to a biologic agent (e.g. shock, anaphylactic reactions).
    19. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening.
    Laboratory exclusion criteria (at screening):
    20. Following laboratory abnormalities at screening*.
    a. White blood cells <3.0 x103 /μL
    b. Absolute neutrophil count <2.0 x 103/μL
    c. Absolute lymphocyte count <0.5 x 103 /μL
    d. Platelet count <10 x 104/μL
    e. Aspartate aminotransferase or alanine aminotransferase >1.5 times the upper limit of normal.
    * If retest is conducted, the last value of retest before randomization must meet study criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first protocol-defined relapse (TFR) in the double-blind period.


    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first protocol-defined relapse (TFR) in the double-blind period.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    i. Change in visual analogue scale (VAS) for pain
    ii. Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue
    iii. Change in Short Form generic health survey score (SF-36)
    iv. Change in EQ-5D
    v. The proportion of relapse-free patients
    vi. Annualized relapse rate (ARR)
    vii. Change in modified Rankin Scale (mRS)
    viii. Change in Zarit Burden Interview (ZBI)
    ix. Change in Expanded Disability Status Scale (EDSS)
    x. Change in visual acuity (Snellen chart)

    Pharmacodynamic endpoints:
    IL-6, soluble IL-6 receptor, high sensitivity C-reactive protein, anti-AQP4 antibodies and plasmablasts.

    Pharmacokinetic endpoints: serum SA237 concentrations

    Immunogenicity endpoints: Incidence of anti-SA237 antibodies

    Exploratory Endpoint: Additional pain assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Selected time points
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    France
    Germany
    Hungary
    Italy
    Japan
    Poland
    Spain
    Taiwan
    United Kingdom
    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
    Last Visit Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 8
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 70
    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 Decision2015-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-17
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