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    Summary
    EudraCT Number:2018-002857-31
    Sponsor's Protocol Code Number:SB12-3003
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-20
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2018-002857-31
    A.3Full title of the trial
    A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity between SB12 (proposed eculizumab biosimilar) and Soliris® in Subjects with Paroxysmal Nocturnal Haemoglobinuria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the effects of SB12 (proposed eculizumab biosimilar) with Soliris® in patients with the disease Paroxysmal Nocturnal Haemoglobinuria
    A.4.1Sponsor's protocol code numberSB12-3003
    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 number8232455 6114
    B.5.5Fax number8232455 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 nameproposed eculizumab biosimilar
    D.3.2Product code SB12
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeculizumab
    D.3.9.2Current sponsor codeSB12
    D.3.9.3Other descriptive nameeculizumab biosimilar
    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 Soliris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/166
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNECULIZUMAB
    D.3.9.1CAS number 219685-50-4
    D.3.9.4EV Substance CodeSUB25187
    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
    Paroxysmal Nocturnal Haemoglobinuria
    E.1.1.1Medical condition in easily understood language
    PNH is a rare blood condition where blood cells are prone to be attacked by part of the body’s immune system.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10034042
    E.1.2Term Paroxysmal nocturnal haemoglobinuria
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate comparable clinical efficacy of SB12 and Soliris®, by evaluating the lactate dehydrogenase (LDH) in subjects with paroxysmal nocturnal haemoglobinuria (PNH).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To evaluate the efficacy of SB12 compared to Soliris® by
    - LDH profile over time
    - Number of units of packed red blood cells (pRBCs) transfused
    • To evaluate the safety and tolerability of SB12 compared to Soliris®
    • To evaluate the pharmacokinetic (PK) of SB12 compared to Soliris®
    • To evaluate the immunogenicity of SB12 compared to Soliris®
    • To evaluate the pharmacodynamic (PD) of SB12 compared to Soliris®
    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. Male or female aged 18 or older at the time of signing the informed consent form (ICF), if local regulations are different in this regard, follow the local regulations.
    2. Documented diagnosis of PNH.
    3. Presence of the PNH white blood cell (WBC) clone ≥ 10% by high-sensitivity flow cytometry at Screening.
    4. Documented LDH level ≥ 1.5 × upper limit of normal (ULN) at Screening.
    5. History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms (e.g., fatigue, haemoglobinuria, abdominal pain, chest pain, shortness of breath [dyspnoea], dysphagia, erectile dysfunction) at Screening.
    6. All subjects must be vaccinated against Neisseria meningitidis within 3 years prior to or on Day 1 in accordance with current local guidelines or Soliris® Summary of Product Characteristics (SmPC) to reduce the risk of meningococcal infection.
    7. Female subjects who are not pregnant or nursing at Screening and on initiation of study drug (Day 1) and who are not planning to become pregnant from Screening until 5 months after the last dose of study drug.
    8. Subjects and their partners of childbearing potential (female or male) who agree to use of a highly effective contraceptive method (e.g., established use of oral, injected or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine system, male sterilisation or true abstinence) from Screening until 5 months after the last dose of study drug.
    9. Subjects must be able to understand the implications of taking part in the study and be willing to follow the study instructions and requirements fully.
    10. Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria are not eligible for the study:
    1. Previous treatment with a complement pathway inhibitor (including eculizumab).
    2. Known hypersensitivity to the investigational product (IP) or any of the ingredients or excipients of the IP.
    3. Known contraindication/hypersensitivity for meningococcal vaccine or the antibiotic to be used in the study.
    4. Abnormal haematological parameters at Screening defined as the following:
    a. Absolute neutrophil count (ANC) ≤ 500/mm3
    b. Platelet count < 70,000/mm3
    5. History of meningococcal disease.
    6. History of bone marrow transplantation.
    7. History of serious thrombotic event (e.g., stroke, myocardial
    infarction, pulmonary embolism, etc.).
    8. Known or suspected active bacterial, virus, fungal infection within 30 days prior to initiation of study drug (Day 1).
    9. Known history of human immunodeficiency virus (HIV) infection or have positive results at Screening.
    10. Concomitant use of any of the following medications is prohibited if the following conditions apply.
    a. Erythropoietin, systemic corticosteroids, low-molecular-weight heparins, iron supplements, and androgen therapy that has not been on a stable dose for at least 4 weeks prior to initiation of study drug (Day 1).
    b. Warfarin with an unstable international normalized ratio (INR) for at least 4 weeks prior to initiation of study drug (Day 1).
    c. Cyclosporine that has not been on a stable dose for at least 8 weeks prior to initiation of study drug (Day 1).
    11. Subjects who have received or participated in another investigational drug, device, or procedures within 30 days or within 5 half-lives of that IP prior to Screening, whichever is greater.
    12. History of malignancy within 5 years prior to Screening, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
    13. Any other cardiac, hepatic, immunologic, pulmonary, rheumatoid disease, other conditions causing rise in LDH (e.g., tumours, muscular dystrophies, liver and bile disease etc.), or the disorder which, at the discretion of the Investigator, will put the subjects at risk if they are enrolled.
    14. Other unspecified reasons that, at the discretion of the Investigator or Sponsor, make the subjects unsuitable for enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    • LDH level (U/L) at Week 26
    • Area under the effect curve (AUEC) of LDH from Week 14 to Week 26 and from Week 40 to Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26 and week 52
    E.5.2Secondary end point(s)
    Efficacy endpoints
    • LDH profile over time
    • Number of units of pRBCs transfused throughout the study duration for each period
    Safety endpoints
    • Incidence of adverse events (AEs) and serious AEs (SAEs)
    • Incidence of infection-related AEs
    - Meningococcal infection
    - Other systemic infections
    • Incidence of infusion-related reactions (IRRs)
    Safety of subjects will be monitored by 12-lead electrocardiogram (ECG), vital sign assessment, and physical
    examination. Haematological, biochemical, and urinalysis laboratory parameters will be also measured.
    PK endpoint
    • Concentration prior to infusion (trough serum concentration [Ctrough])
    Immunogenicity endpoints
    • Incidence of anti-drug antibodies (ADAs)
    • Incidence of neutralising antibodies (NAbs)
    PD endpoint
    • Terminal complement activity
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: end of study
    Safety: end of study
    PK endpoint: at Weeks 0 (Day 1), 2, 4, 6, 10, 14, 18, 22, 26, 28, 30, 32, 36, 40, 44, 48, and 52
    Immunogenicity endpoints:
    ADAs at Weeks 0 (Day 1), 2, 4, 6, 10, 14, 18, 22, 26, 28, 30, 32, 36, 40, 44, 48, 52, and end of study (EOS)/early termination (ET)
    NAbs at Weeks 0 (Day 1), 2, 4, 6, 10, 14, 18, 22, 26, 28, 30, 32, 36, 40, 44, 48, 52, and EOS/ET
    PD endpoint: at Weeks 0 (Day 1), 2, 4, 6, 10, 14, 26, 28, 30, 32, 36, 40, and 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 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
    To demonstrate biosimilarity of SB12 to the comparator
    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 No
    E.8.1.6Cross over Yes
    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 No
    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
    China
    India
    Korea, Republic of
    Malaysia
    Mexico
    Taiwan
    Thailand
    Romania
    Turkey
    Ukraine
    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 days5
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days5
    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: 50
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 50
    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 Decision2019-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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