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    Summary
    EudraCT Number:2020-004278-23
    Sponsor's Protocol Code Number:CT-P42_3.1
    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:2021-01-04
    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 number2020-004278-23
    A.3Full title of the trial
    A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison with Eylea in Patients with Diabetic Macular Edema
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 study to evaluate the efficacy and safety of CT-P42 versus Eylea as treatment for patients with Diabetic Macular Edema.
    A.4.1Sponsor's protocol code numberCT-P42_3.1
    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 SponsorCELLTRION Inc.
    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 supportCELLTRION Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCELLTRION Inc.
    B.5.2Functional name of contact pointByeong Hyeon Kim
    B.5.3 Address:
    B.5.3.1Street Address23, Academy-ro, Yeonsu-gu
    B.5.3.2Town/ cityIncheon
    B.5.3.3Post code22014
    B.5.3.4CountryKorea, Republic of
    B.5.6E-mailbyeonghyeon.Kim@celltrion.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 nameAflibercept
    D.3.2Product code CT-P42
    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 codeCT-P42
    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 40 mg/mL solution for injection in a vial
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameEylea
    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.IMP: 3
    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 nameAflibercept
    D.3.2Product code CT-P42
    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 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 codeCT-P42
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Macular Edema
    E.1.1.1Medical condition in easily understood language
    Diabetic Macular Edema
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 100000004853
    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 that CT-P42 is similar to Eylea in terms of efficacy as determined by clinical response according to the mean change from baseline at Week 8 in Best Corrected Visual Acuity (BCVA) using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
    E.2.2Secondary objectives of the trial
    To evaluate additional efficacy, pharmacokinetics (PK), usability, and overall safety including immunogenicity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all of the following criteria to be enrolled in this study:

    1. Male or female patient aged ≥18 years.
    2. Patient who has type 1 or 2 DM.
    3. Patient with DME secondary to DM involving the center of the macula (defined as the Optical Coherence Tomography [OCT] central subfield) in the study eye.
    4. Patient whose central subfield retinal thickness is ≥350 μm as assessed by OCT based on central results in the study eye at Screening..
    5. Patient who has BCVA score of 73 to 34 (approximate Snellen equivalent of 20/40 to 20/200) using ETDRS charts in the study eye at Screening and Day 1 (for more detailed BCVA procedures, see the study procedure manual).
    6. Decrease in vision determined to be primarily the result of DME in the study eye.
    7. Patient and/or their legally authorized representative are informed and will be given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the informed consent form (ICF) before any specific procedures.
    8. Female patient must agree to use highly effective methods of contraception consistent with local regulations during the course of the study and for at least 3 months following discontinuation of study drug (excluding women who are not of childbearing potential). Examples include the following:
    a) Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives associated with inhibition of ovulation
    b) Intrauterine device or intrauterine hormone-releasing system
    c) True abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception.
    A woman is considered of childbearing potential, following menarche and until becoming post-menopausal unless surgically sterile. Menopausal female patients must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential. Male patient who is sexually active with a woman of childbearing potential must agree to use highly effective method described as above or 2 acceptable methods of contraception (e.g., Male or female condom AND additional hormonal or barrier contraceptive method other than condom by female partner) consistent with local regulations during the course of the study and for at least 3 months following discontinuation of study drug. Contraception is not required if either patient or his/her partner who has been surgically sterilized more than 24 weeks prior to the date of informed consent.
    E.4Principal exclusion criteria
    A patient meeting any of the following criteria are not eligible for inclusion in this study:

    1. Patient who has only one functional eye, even if the eye met all other study requirements, or has and/or is likely to have amblyopia, amaurosis or ocular disorder with BCVA < 34 ETDRS letter score (approximate Snellen equivalent of < 20/200) in the fellow eye
    2. Patient who currently has, or has a history (where indicated) of ocular condition including one or more of the following in the study eye:
    a) Active proliferative diabetic retinopathy, or pre-retinal fibrosis involving the macula
    b) Aphakia
    c) Vitreomacular traction or epiretinal membrane that is expected to affect central vision
    d) Iris neovascularization, vitreous hemorrhage, or tractional retinal detachment
    e) Ocular inflammation (including trace or above)
    f) Uncontrolled glaucoma or filtration surgery for glaucoma in the past or likely to be needed in the future
    g) Intraocular pressure (IOP) ≥25 mmHg
    h) Spherical equivalent of the refractive error of worse than -6 diopters myopia
    i) Structural damage to the center of the macula that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates
    j) Concurrent and/or history of disease, other than DME, that could compromise visual acuity, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause) as assessed by the investigator
    k) Inability to obtain fundus and OCT images due to, but not limited to, insufficient media clarity or inadequate pupil dilation
    3. Patient who currently has, or has a history (where indicated) of ocular condition including one or more of the following in either eye:
    a) Concurrent and/or history of idiopathic or autoimmune uveitis
    b) Evidence or suspicion of infection including blepharitis, keratitis, scleritis, or conjunctivitis.
    However, a patient who has completely recovered from the infection at Day 1 is allowed to be enrolled at the investigator’s discretion.
    4. Patient who currently has, or has a history of (where indicated) systemic condition including one or more of the following:
    a) Uncontrolled DM as defined by hemoglobin A1c >10%
    b) Uncontrolled blood pressure defined as systolic ≥160 mmHg or diastolic ≥100 mmHg measured after 5 minutes of rest while sitting
    c) History of vascular disease such as cerebrovascular accident, myocardial infarction, transient ischemic attack, or thromboembolic reaction including pulmonary embolism within 180 days prior to the first study drug administration
    d) New York Heart Association Functional Classification Class III or IV heart failure, or severe uncontrolled cardiac disease (i.e., unstable angina)
    e) Current treatment for serious systemic infection
    f) History of recurrent significant infections in the opinion of the investigator
    g) Renal failure requiring dialysis or renal transplant
    h) History of malignancies within 5 years prior to the first study drug administration, except adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ
    i) History of other disease, metabolic dysfunction, physical examination finding, electrocardiogram (ECG) finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, contraindicates the use of the study drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
    j) Evidence of significant uncontrolled concomitant diseases including cardiovascular system, nervous system, pulmonary, renal, hepatic, endocrine, gastrointestinal disorders, or psychiatric condition as assessed by the investigator.

    For the complete list of exclusion criteria please refer to the study protoocol, section 4.1.2
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the mean change from baseline in BCVA using the ETDRS chart at Week 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    The following secondary efficacy endpoints will be assessed at each applicable visit up to Week 52, Extension Week 0 and 4:
    - Mean change in BCVA using the ETDRS chart from baseline;
    - Proportion of patients who gained ≥ 5, ≥ 10, and ≥ 15 ETDRS letters from baseline in BCVA using the ETDRS chart;
    - Proportion of patients who lost ≥ 5, ≥ 10, and ≥ 15 ETDRS letters from baseline in BCVA using the ETDRS chart;
    - Mean change in central subfield thickness from baseline as determined by spectral domain optical coherence tomography (SD-OCT);
    - Percentage of patients with a ≥ 2-step improvement from baseline in the ETDRS DRSS score as assessed by fundus photography (FP)

    The following secondary PK endpoints will be assessed:

    - Maximum plasma concentration after the first study drug administration (Cmax1);
    - Maximum plasma concentration after the fifth study drug administration (Cmax2);
    - Time of observed maximum plasma concentration after the first study drug administration (Tmax1);
    - Time of observed maximum plasma concentration after the fifth study drug administration (Tmax2);

    The following secondary usability endpoint will be assessed:

    - Number of injections with vial kit successfully administered by healthcare professionals at Week 0
    - Number of injections with PFS successfully administered by healthcare professionals at Extension Week 0

    The following secondary safety endpoints will be assessed:

    - Incidence and severity of AEs (ocular and non ocular) including SAEs;
    - Incidence and severity of adverse event of special interest (AESI);
    - Intraocular pressure test, slit lamp examination, indirect ophthalmoscopy, finger count/hand motion/light perception, hypersensitivity monitoring, vital signs and weight measurement, electrocardiogram (ECG), New York Heart Association (NYHA) Functional Classification assessment, physical examination findings, pregnancy testing, clinical laboratory analyses including hemoglobin A1c (HbA1c);
    - Immunogenicity, as assessed by incidence of anti-drug antibody and neutralizing antibody;
    - Prior and concomitant treatments
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Efficacy endpoints at week 52, Extension Week 0 and 4

    - Secondary PK and safety endpoints throughout the study

    - Usability endpoint at Week 0 and Extension Week 0

    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 Yes
    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
    Usability and immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study Yes
    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 Yes
    E.8.1.7.1Other trial design description
    PFS Extension Study is open label, one arm. Only the Main Study is controlled.
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    India
    Korea, Republic of
    Estonia
    Latvia
    Lithuania
    Poland
    Spain
    Czechia
    Germany
    Hungary
    Russian Federation
    Slovakia
    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
    The end of the study is defined as the date of the final CSR generated.
    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 months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days29
    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: 253
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 107
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 189
    F.4.2.2In the whole clinical trial 360
    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 Decision2021-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-22
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