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    Summary
    EudraCT Number:2020-001479-34
    Sponsor's Protocol Code Number:SB16-3001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-21
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-001479-34
    A.3Full title of the trial
    A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity between SB16 (proposed denosumab biosimilar) and Prolia® in Postmenopausal Women with Osteoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical study to compare SB16 and Prolia® in postmenopausal women with osteoporosis.
    A.4.1Sponsor's protocol code numberSB16-3001
    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+82324556114
    B.5.5Fax number+82324556499
    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 nameSB16, proposed denosumab biosimilar
    D.3.2Product code SB16
    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 INNDenosumab
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeSB16
    D.3.9.3Other descriptive nameDENOSUMAB
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Prolia
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEU sourced Prolia®
    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 INNDenosumab
    D.3.9.1CAS number 615258-40-7
    D.3.9.3Other descriptive nameDENOSUMAB
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Postmenopausal osteoporosis
    E.1.1.1Medical condition in easily understood language
    Osteoporosis in women after menopause
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 SB16 to Prolia®, in terms of percent change from baseline in lumbar spine bone mineral density (BMD) at Month 12 in subjects with postmenopausal osteoporosis (PMO).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of SB16 compared to Prolia® by
    -Percentage change from baseline in lumbar spine BMD
    -Percentage change from baseline in total hip BMD
    -Percentage change from baseline in femoral neck BMD
    To evaluate the safety and tolerability of SB16 compared to Prolia®
    To evaluate the pharmacokinetic (PK) profile of SB16 compared to Prolia®
    To evaluate the pharmacodynamic (PD) profile of SB16 compared to Prolia®
    To evaluate the immunogenicity of SB16 compared to Prolia®
    To evaluate the safety, tolerability, immunogenicity, PK, PD, and efficacy in subjects with PMO who transitioned to SB16 from Prolia® compared to subjects who maintained Prolia® from the Main period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria to be eligible for the study:
    1.Postmenopausal women (defined as lack of menstrual period for at least 12 months prior to Screening, for which there is no other pathological or physiological cause) who are 55 to 80 years of age at Screening
    Serum follicle stimulating hormone (FSH) test can be done at Screening in case of uncertainty.
    2.Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator
    3.Absolute BMD consistent with T-score at the total hip or lumbar spine of ≥ ‒4 and ≤ ‒2.5, determined by central imaging centre at Screening
    4.At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement, determined by central imaging centre at Screening
    5.Biologic (defined as any therapeutic monoclonal antibody or fusion receptor protein, including denosumab, denosumab biosimilars, or romosozumab) naïve at Screening
    6.Body weight of ≥ 50 kg and ≤ 90 kg at Screening
    7.Has provided informed consent voluntarily and must be able to, in the opinion of the Investigator, understand the implications of taking part in the study, be willing to follow the study requirements, and complete the study

    Subjects must meet the following criteria to be enrolled in the Transition period:
    1.Have been enrolled and completed the scheduled Month 12 of the Main period of the SB16-3001 study
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria are not eligible for the study:
    1.One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification, determined by central imaging centre at Screening
    2.History of hip fracture or bilateral hip replacement at Screening
    3.Uncorrected vitamin D deficiency
    4.Hypercalcemia or hypocalcaemia at Screening
    5.Inadequate haematological function at Screening
    6.Inadequate renal or hepatic function at Screening
    7.Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the investigational product (IP), including latex allergy or hereditary problems of fructose intolerance at Screening
    8.May not tolerate long-term calcium or vitamin D supplementation or subject with malabsorption of calcium or vitamin D supplements, in the opinion of the Investigator, at Screening
    9.Use of any of the medications that can affect BMD
    10.Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening
    11.Non-osteoporosis medical conditions that can affect BMD at Screening

    23.Any clinically significant disease or disorder or laboratory abnormality which, in the opinion of the Investigator, would prevent the subject from completing the study or the interpretation of the study results at Screening and Randomisation

    Subjects meeting the following criteria must not be enrolled in the Transition period:
    1.Found to be of increased risk to continue enrolment, in the opinion of the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in lumbar spine BMD
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    E.5.2Secondary end point(s)
    Secondary endpoints for the Main period
    Efficacy endpoints
    -Percent change from baseline in lumbar spine BMD
    -Percent change from baseline in total hip BMD
    -Percent change from baseline in femoral neck BMD
    Safety endpoints
    -Incidence of adverse events (AEs)
    -Incidence of serious AEs (SAEs)
    PK endpoint
    -Serum drug concentration
    PD endpoints
    -Serum C-telopeptide of type I collagen (CTX) concentration
    -Area under the effect curve from time zero to Month 6 (AUEC0-M6) of
    percent change from baseline in serum CTX
    -Serum procollagen type I N-terminal propeptide (P1NP) concentration
    Immunogenicity endpoint
    -Incidence of anti-drug antibodies (ADAs)
    -Incidence of neutralising antibodies (NAbs)

    Secondary endpoints for the Transition period
    Safety endpoints
    -Incidence of AEs
    -Incidence of SAEs
    Immunogenicity endpoint
    -Incidence of ADAs and NAbs
    Efficacy endpoints
    -Percent change from baseline in lumbar spine BMD
    -Percent change from baseline in total hip BMD
    -Percent change from baseline in femoral neck BMD
    PK endpoint
    -Serum drug concentration
    PD endpoint
    -Serum CTX concentration
    -Serum P1NP concentration
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints for the Main period
    Safety endpoints during whole study
    Efficacy endpoints
    -Percent change from baseline in lumbar spine BMD at Month 6
    -Percent change from baseline in total hip BMD at Month 6 and 12
    -Percent change from baseline in femoral neck BMD at Month 6 and 12
    PK endpoint at Months 0, 0.5, 1, 3, 6, 9, and 12
    PD endpoints
    -Serum CTX at Months 0, 0.5, 1, 3, 6, 9, and 12
    -AUEC0-M6 at Month 6
    -Serum P1NP at Months 0, 0.5, 1, 3, 6, 9, and 12
    Immunogenicity endpoint
    -Incidence of ADAs at Months 0, 0.5, 1, 3, 6, 9, and 12
    -Incidence of NAbs at Months 0, 0.5, 1, 3, 6, 9 and 12

    Secondary endpoints for the Transition period
    Safety endpoints during whole study
    Immunogenicity, efficacy, PK and PD endpoints at Month 18
    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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Korea, Republic of
    Czechia
    Denmark
    Hungary
    Lithuania
    Poland
    Bulgaria
    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
    A subject is considered to have completed the study if she has completed the last scheduled visit or the last scheduled procedure shown in the Schedule of Activities. EOS is defined as completion of the last scheduled visit (Month 18). The end of this clinical study is defined as completion of the last subject’s EOS/ET.
    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 months2
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days8
    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: 346
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 323
    F.4.2.2In the whole clinical trial 432
    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)
    Standard of care
    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 Decision2020-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-03
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