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    Summary
    EudraCT Number:2015-005431-41
    Sponsor's Protocol Code Number:BN40900(SA-309JG)
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-07
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-005431-41
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
    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 Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder
    A.4.1Sponsor's protocol code numberBN40900(SA-309JG)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02073279
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrials Information Supprt Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 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.3.1Product nameSatralizumab (120 mg/vial)
    D.3.2Product code Satralizumab (RO5333787/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 INNSatralizumab (r-INN)
    D.3.9.1CAS number 1535963-91-7
    D.3.9.2Current sponsor codeRO5333787
    D.3.9.3Other descriptive nameRO5333787
    D.3.9.4EV Substance CodeSUB197260
    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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSatralizumab (120 mg/PFS with NSD)
    D.3.2Product code Satralizumab (RO5333787/SA237)
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSatralizumab (r-INN)
    D.3.9.1CAS number 1535963-91-7
    D.3.9.2Current sponsor codeSatralizumab (RO5333787/SA237)
    D.3.9.3Other descriptive nameRO5333787
    D.3.9.4EV Substance CodeSUB197260
    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 Yes
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029322
    E.1.2Term Neuromyelitis optica
    E.1.2System Organ Class 100000004852
    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 monotherapy in patients with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (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 either
    a. NMO as defined by Wingerchuk 2006 criteria*, or
    b. NMOSD as defined by either of following criteria with anti-aquaporin-4 (AQP4) antibody 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, single, recurrent or simultaneous bilateral
    2. Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening.
    3. Expanded disability status scale (EDSS) score from 0 to 6.5 inclusive at screening.
    4. Age 18 to 74 years, inclusive at the time of informed consent.
    5. 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 following 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 NMO:
    1. Clinical relapse onset (including first attack) within 30 days prior to baseline.
    Exclusion Criteria Related to Previous or Concomitant Therapy:
    2. Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time.
    3. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.
    4. Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline.
    5. Treatment with any investigational agent within 3 months prior to baseline.
    Exclusions for General Safety:
    6. Pregnancy or lactation.
    7. 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.
    8. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.
    9. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
    10. Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, as described; 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
    11. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
    12. Evidence of chronic active hepatitis B or C.
    13. History of drug or alcohol abuse within 1 year prior to baseline.
    14. History of diverticulitis that, in the Investigator’s opinion, may lead to increased risk of complications such as lower gastrointestinal perforation.
    15. Evidence of active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection).
    16. Evidence of active interstitial lung disease.
    17. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline.
    18. 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).
    19. History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions).
    20. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening.
    21. History of Stevens-Johnson syndrome.
    Laboratory Exclusion criteria (at screening):
    22. 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 (AST) or alanine aminotransferase (ALT) > 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)
    Primary endpoint:
    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) score for pain
    ii. Change in Functional Assessment Of Chronic Illness Therapy (FACIT) Fatigue score
    iii. Change in Short Form Generic Health Survey (SF-36) score
    iv. Change in EQ-5D score
    v. Change in Timed 25-Foot Walk (T25W)
    vi. The proportion of relapse-free patients
    vii. Annualized relapse rate (ARR)
    viii. Change in modified Rankin Scale (mRS) score
    ix. Change in Zarit Burden Interview (ZBI) score
    x. Change in EDSS scores
    xi. Change in visual acuity (Snellen chart)
    xii. Change in low-contrast visual acuity (low-contrast Sloan letter chart [LCSLC])
    Exploratory endpoint:
    i. MRI scans of the brain, optic nerve and spinal cord
    MRI for exploratory evaluation is optional and will be conducted at selected sites.
    Pharmacokinetic/Pharmacodynamic Outcome Measures:
    i. Serum SA237 concentration, IL-6, soluble IL-6 receptor (sIL-6R), high sensitivity C-reactive protein (hsCRP), anti-AQP4 antibody, plasmablast
    Immunogenicity Outcome Measures:
    i. Incidence of anti-SA237 antibodies
    ii. PK, PD, clinical response, and safety during the study by anti-SA237 antibody status
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 EEA13
    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
    Bulgaria
    Canada
    Croatia
    Georgia
    Italy
    Korea, Republic of
    Malaysia
    Poland
    Romania
    Russian Federation
    Taiwan
    Turkey
    Ukraine
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months5
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 90
    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 Decision2016-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-31
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