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    Summary
    EudraCT Number:2017-000422-36
    Sponsor's Protocol Code Number:SB11-G31-AMD
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000422-36
    A.3Full title of the trial
    A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB11 (proposed ranibizumab biosimilar) and Lucentis® in Subjects with Neovascular Age-related Macular Degeneration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SB11 versus Lucentis® in subjects with neovascular age-related macular degeneration
    A.3.2Name or abbreviated title of the trial where available
    SB11_G31_AMD
    A.4.1Sponsor's protocol code numberSB11-G31-AMD
    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 SponsorSamsung Bioepis Co., Ltd.
    B.1.3.4CountryKorea, Republic of
    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 supportSamsung Bioepis Co., Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSamsung Bioepis Co., Ltd.
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street Address107, Cheomdan-daero, Yeonsu-gu
    B.5.3.2Town/ cityIncheon
    B.5.3.3Post code21987
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number +82 (32) 455 6114
    B.5.5Fax number +82 (32) 455 6499
    B.5.6E-mailbioepisinfo@samsung.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 nameSB11 (proposed ranibizumab biosimilar)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.2Current sponsor codeSB11
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Lucentis® (sourced from USA)
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLucentis® (sourced from USA)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neovascular Age-related Macular Degeneration
    E.1.1.1Medical condition in easily understood language
    Degenerative retinal disease characterized by damage to the macula, swelling and haemorrhages. Central vision can be blurred, decreased or even lost.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the equivalence of efficacy of SB11 to Lucentis® in subjects with neovascular age-related macular degeneration
    E.2.2Secondary objectives of the trial
    •To evaluate the safety of SB11 and Lucentis®
    •To evaluate the immunogenicity of SB11 and Lucentis®
    •To evaluate the systemic exposure of SB11 and Lucentis® in subjects participating in pharmacokinetics (PK) evaluation
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics Analyses: For safety purpose, PK sampling will be collected in approximately 40 subjects participating in PK evaluation (20 subjects per treatment group). Formal PK analysis will not be performed. The systemic exposure will be summarised descriptively by treatment group and visit.
    The pharmacokinetic endpoints are:
    •Blood sampling for PK will be collected in approximately 40 subjects participating in PK evaluation (20 subjects per treatment group).
    •Systemic exposure measured pre-dose (Ctrough) and 24 to 72 hours post-dose (close to Cmax)
    E.3Principal inclusion criteria
    1.Age ≥ 50 years at Screening
    2.Newly diagnosed, *active subfoveal Choroidal Neovascularisation (CNV) lesion secondary to AMD in the study eye
    * Active CNV indicates presence of leakage and intra- or sub-retinal fluid which should be confirmed by central reading centre during Screening
    3.The area of CNV must occupy at least 50% of total lesion in the study eye (confirmed by central reading centre during Screening)
    4.Total lesion area ≤ 9.0 Disc Areas (DA) in size (including blood, scars and neovascularisation) in the study eye (confirmed by central reading centre during Screening)
    5.Best Corrected Visual Acuity (BCVA) of 20/40 to 20/200 (letter score of 73 to 34) using original series Early Treatment Diabetic Retinopathy Study (ETDRS) charts or 2702 series Number charts in the study eye at Screening and at Week 0 (Day 1) prior to randomisation
    6.Non-childbearing potential female (e.g., permanently sterilised, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening]), OR Childbearing potential female subjects or male subjects with their (respectively male or female) partners who agree to use at least two forms of appropriate contraception method that can achieve a failure rate of less than 1% per year (e.g., established use of oral, injected, intravaginal, transdermal or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, physical barrier, sexual abstinence) from Screening until 3 months after the last ITV injection of IP
    7.Written informed consent form must be obtained from the subject prior to any study related procedure (If the subject is legal blindness or illiterate, an impartial witness should be present during the entire informed consent discussion)
    8.Willingness and ability to undertake all scheduled visits and assessments
    E.4Principal exclusion criteria
    1.Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion in the study eye, or presence of subfoveal blood equal to or more than one DA in size (confirmed by central reading centre during Screening)
    2.Scar, fibrosis or atrophy involving the centre of the fovea in the study eye (confirmed by central reading centre during Screening)
    3.Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or Pathologic Myopia (PM) (confirmed by central reading centre during Screening)
    4.Presence of retinal pigment epithelial tears or rips involving the macula in the study eye as assessed by FA (confirmed by central reading centre during Screening)
    5.Presence of macular hole at any stage in the study eye (confirmed by central reading centre during Screening)
    6.Any concurrent macular abnormality other than AMD in the study eye which, could affect the efficacy of IP including but not limited to epiretinal membrane, macular telangiectasia, retinal vascular abnormality, etc. (confirmed by central reading centre during Screening)
    7.History of vitrectomy surgery in the study eye
    8.History of trabeculectomy or other filtration surgery in the study eye
    9.History of submacular surgery or other surgical intervention for AMD in the study eye
    10.Any other intraocular surgery (including cataract surgery) or periocular surgery in the study eye within 90 days prior to randomisation, except for lid surgery, which may not have taken place within 30 days prior to randomisation
    11.Any previous ITV anti-Vascular Endothelial Growth Factor (anti-VEGF) treatment (e.g., bevacizumab, aflibercept, ranibizumab) to treat neovascular AMD in either eye
    12.Any previous systemic anti-VEGF treatment, within 90 days prior to randomisation, and such treatment will not be allowed during the study period
    13.Any systemic treatment or therapy (including prescribed herbal medication) to treat neovascular AMD within 30 days prior to randomisation, and such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins or mineral will be allowed
    14.Any intravitreal injection of corticosteroid (e.g., triamcinolone acetonide) or intravitreal corticosteroid implant in the study eye within 180 days prior to randomisation, and such treatment will not be allowed during the study period
    15.Topical ocular corticosteroids administered for ≥ 30 consecutive days in the study eye within 90 days prior to randomisation
    16.Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia. For subjects who have undergone previous refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must not exceed 8 diopters of myopia
    17.Aphakia or absence of the posterior capsule in the study eye
    18.Presence of scleromalacia in either eye
    19.Current vitreous haemorrhage in the study eye
    20.Active or recent (within 28 days prior to randomisation) intraocular, extraocular and periocular inflammation or infection in either eye
    21.History of idiopathic or autoimmune uveitis in either eye
    22.History of retinal detachment in the study eye
    23.History of full-thickness macular hole in the study eye
    24.History of corneal transplantion surgery in the study eye
    25.Presence of advanced glaucoma or optic neuropathy that affect or threaten the central visual field in the study eye
    26.Uncontrolled ocular hypertension (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication) in the study eye
    27.History of allergy to the fluorescein sodium for injection in angiography
    28.Previous participation in clinical studies of ocular investigational products to treat neovascular AMD
    29.Previous participation in any studies of ocular or systemic investigational products to treat ocular or systemic disease within 90 days prior to randomisation
    30.History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy), or diabetic macular oedema in either eye
    31.Any concurrent ocular condition in the study eye which, in the opinion of the Investigator, could either increase the risk to the subject safety or which otherwise may interfere with evaluation of efficacy or safety.
    32.Stroke, transient ischemic attacks, or myocardial infarction within 90 days prior to randomisation 33.History of recurrent significant or active infections
    34.Known allergic reactions and/or hypersensitivity to ranibizumab or to any ingredients of SB11
    35.Prior treatment involving macula with photodynamic therapy with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser treatment
    36.Prior treatment with pan-retinal photocoagulation in the study eye
    37.Current use of systemic medications known to be toxic to the lens, retina or optic nerve
    E.5 End points
    E.5.1Primary end point(s)
    For European Medicines Agency (EMA) or other regulatory agency submissions for those who are in favour of the anatomical parameter, the primary endpoint is:
    •Change from baseline in Central Subfield Thickness (CST) at Week 4 (based on assessment by central reading centre)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and week 4
    E.5.2Secondary end point(s)
    •Change from baseline in BCVA over time up to Week 24 and Week 52
    •Proportion of subjects who lost fewer than 15 letters in BCVA compared to baseline at Week 24 and Week 52
    •Proportion of subjects who gained 15 letters or more in BCVA compared to baseline at Week 24 and Week 52
    •Change from baseline in CST and Central Retinal Lesion Thickness (CRLT) at Week 24 and Week 52 (based on assessment by central reading centre)
    •Change from baseline in total CNV size at Week 24 and Week 52 (based on assessment by central reading centre)
    •Proportion of subjects with active CNV leakage at Week 24 and Week 52 (based on assessment by central reading centre)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, week 24, week 52
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Czech Republic
    Germany
    Hungary
    India
    Korea, Republic of
    Poland
    Russian Federation
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 352
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 352
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the subject is legal blindness or illiterate, an impartial witness should be present during the entire informed consent discussion
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Legal blindness and illiterate
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 299
    F.4.2.2In the whole clinical trial 704
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-09
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