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    Summary
    EudraCT Number:2019-003883-28
    Sponsor's Protocol Code Number:SB15-3001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-05
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-003883-28
    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 SB15 (proposed aflibercept biosimilar) and Eylea® in Subjects with Neovascular Age-related Macular Degeneration
    Randomizovaná, dvojitě maskovaná, multicentrická studie fáze III prováděná v paralelních skupinách k porovnání účinnosti, bezpečnosti, farmakokinetiky a imunogenicity přípravku SB15 (navrhovaný biosimilární aflibercept) a přípravku Eylea® u pacientů s neovaskulární formou věkem podmíněné makulární degenerace
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical study to compare SB15 and Eylea® in patients with neovascular age-related macular degeneration
    A.4.1Sponsor's protocol code numberSB15-3001
    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 Address76, Songdogyoyuk-ro, Yeonsu-gu
    B.5.3.2Town/ cityIncheon
    B.5.3.3Post code21987
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82 32 728 0114
    B.5.5Fax number+82 32 728 3321
    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 nameSB15, proposed aflibercept biosimilar
    D.3.2Product code SB15
    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 INNAflibercept
    D.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeSB15
    D.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Eylea®
    D.2.1.1.2Name of the Marketing Authorisation holderRegeneron Pharmaceuticals, 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.3.4Pharmaceutical 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 INNAflibercept
    D.3.9.1CAS number 862111-32-8
    D.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Neovascular age-related macular degeneration
    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
    The primary objective of this study is to demonstrate the equivalence in efficacy of SB15 compared to Eylea® in subjects with neovascular age-related macular degeneration (AMD).
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of SB15 compared to Eylea®
    • To evaluate the systemic exposure of SB15 compared to Eylea® in subjects participating in
    pharmacokinetics (PK) evaluation
    • To evaluate the immunogenicity of SB15 compared to Eylea®
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Blood samples for PK assessment will be collected in approximately 40 subjects (20 subjects per treatment group in initial randomisation at Week 0 [Day 1]) participating in PK evaluation.
    E.3Principal inclusion criteria
    1. Age ≥ 50 years at Screening
    2. Treatment naïve, *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 the central reading centre during Screening.
    3. The area of CNV must occupy at least 50% of total lesion in the study eye (confirmed by the 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 the central reading centre during Screening)
    5. BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) 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 sterilized, 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 IVT injection of IP
    7. Written informed consent form (ICF) 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. Study eye: Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea
    2. Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea
    3. Study eye: Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia
    4. Study eye: Presence of retinal pigment epithelial tears or rips involving the macula
    5. Study eye: Presence of macular hole at any stage
    6. Study eye: Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP including but not limited to epiretinal membrane, vitreomacular traction, macular telangiectasia, retinal vascular abnormality, etc.
    7. Study eye: Any concurrent ocular condition which, in the opinion of the Investigator, could either confound the interpretation of efficacy and safety of IP or require medical or surgical intervention during the study period
    8. Either eye: History or clinical evidence of diabetic retinopathy or diabetic macular oedema (DME)
    9. Study eye: Current vitreous haemorrhage
    10. Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment
    11. Any previous systemic anti-VEGF treatment
    12. Study eye: History of treatment involving macula such as macular laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, or any ocular treatment for neovascular AMD
    13. Any systemic treatment or therapy to treat neovascular AMD within 30 days prior to randomisation, and such treatment or therapy will not be allowed during the study period.
    14. Study eye: History of vitrectomy, scleral bucking (encircling), glaucoma filtration surgery, corneal transplantation, or pan-retinal photocoagulation
    15. Study eye: Previous ocular (intraocular and peribulbar) corticosteroids injection/implant within 1 year prior to randomisation
    16. Study eye: Topical ocular corticosteroids administered for ≥ 30 consecutive days or for ≥ 60 non-consecutive days within 90 days prior to randomisation
    17. Use of systemic corticosteroids for 30 or more consecutive days within 90 days prior to randomisation.
    18. Study eye: Any other intraocular surgery or periocular surgery within 90 days prior to randomisation, except for lid surgery, which may not have taken place within 30 days prior to randomisation.
    19. Current use of medications known to be toxic to the lens, retina, or optic nerve, including at Screening and such medications will not be allowed during the study period.
    20. Study eye: Previous radiation therapy near the region of the study eye
    21. Previous participation in clinical studies with IP to treat neovascular AMD in either eye.
    22. Previous participation in clinical studies with IP to treat disease other than neovascular AMD within 90 days prior to randomisation.
    23. Subject with only one functional eye
    24. Study eye: Spherical equivalent of the refractive error demonstrating more than 6 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 cannot exceed 6 diopters of myopia.
    25. Study eye: Aphakia or absence of the posterior capsule
    26. Either eye: Active or suspected ocular and periocular infection at Screening or at randomisation
    27. Either eye: Active intraocular inflammation including scleritis at Screening or at randomisation
    28. Either eye: History of idiopathic or autoimmune-associated uveitis
    29. Study eye: Uncontrolled ocular hypertension at Screening
    30. Known allergic reactions and/or hypersensitivity to any component of Eylea® or SB15
    31. History of allergy to the fluorescein sodium for injection in angiography
    32. History of a medical condition that would preclude scheduled study visits or safe use of IP in the opinion of the Investigator
    33. Uncontrolled systemic disease including but not limited to uncontrolled diabetes mellitus, uncontrolled systemic hypertension, or uncontrolled atrial fibrillation at Screening
    34. Stroke, transient ischaemic attacks, or myocardial infarction within 180 days prior to randomisation 35. History of recurrent significant infections and/or current treatment for systemic infection
    36. Severe renal impairment with dialysis or a history of renal transplant
    37. Malignancy under treatment or with history of metastatic disease
    38. Women of childbearing potential who are pregnant, planning to become pregnant, lactating, or not using adequate birth control, as specified in protocol. For women of childbearing potential, a serum pregnancy test must result negative at Screening.
    39. Employees of investigational sites, individuals directly involved with the conduct of the study, prisoners, and persons who are legally institutionalized
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in BCVA at Week 8
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 8
    E.5.2Secondary end point(s)
    • Change from baseline in BCVA over time up to Week 32 and up to Week 56
    • Proportion of subjects who lost fewer than 15 letters in BCVA compared to baseline at Week 32 and Week 56 (proportion of subjects who maintained BCVA)
    • Proportion of subjects who gained 15 letters or more in BCVA compared to baseline at Week 32 and Week 56
    • Change from baseline in central subfield thickness (CST) and total retinal thickness (TRT) at Week 4, and over time up to Week 32 and up to Week 56 (based on assessment by the central reading centre)
    - CST measured from internal limiting membrane (ILM) to retinal pigment epithelium (RPE) in 1-mm central subfield
    - TRT measured from ILM to Bruch’s membrane (BM) in 1-mm central subfield
    • Proportion of subjects with intra- or sub-retinal fluid on optical coherence tomography (OCT) at Week 32 and Week 56 (based on assessment by the central reading centre)
    • Change from baseline in CNV area at Week 32 and Week 56 (based on assessment by the central reading centre)
    • Proportion of subjects with active CNV leakage at Week 32 and Week 56 (based on assessment by the central reading centre)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to section E.5.2
    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 EEA31
    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
    Croatia
    Czechia
    Estonia
    Hungary
    Japan
    Korea, Republic of
    Latvia
    Poland
    Russian Federation
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 591
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 421
    F.4.2.2In the whole clinical trial 687
    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 Decision2020-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-16
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