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    Summary
    EudraCT Number:2021-000590-93
    Sponsor's Protocol Code Number:CR213-20
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-02
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2021-000590-93
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Parallel Group, Multicenter Study to Compare Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BP05 Versus EU-Approved Lucentis® in Patients with Wet (Neovascular) Age-Related Macular Degeneration
    Randomizované, dvojito zaslepené, multicentrické klinické skúšanie fázy 3 s paralelnými skupinami porovnávajúce účinnosť, bezpečnosť, farmakokinetiku a imunogenicitu produktu BP05 s prípravkom Lucentis®, schváleným v EÚ, u pacientov s vlhkou (neovaskulárnou) vekom podmienenou degeneráciou makuly.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the efficacy, safety, pharmacokinetics, and Immunogenicity of BP05 Versus EU-Approved Lucentis in adults patients with Wet (Neovascular) Age-Related Macular Degeneration
    A.4.1Sponsor's protocol code numberCR213-20
    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 SponsorCuraTeQ Biologics Private Ltd.
    B.1.3.4CountryIndia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCuraTeQ Biologics Private Ltd.
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHungaroTrial CRO
    B.5.2Functional name of contact pointDaniela Marchidanu
    B.5.3 Address:
    B.5.3.1Street AddressFehérvári út 89-95.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1119
    B.5.3.4CountryHungary
    B.5.4Telephone number+03612032134
    B.5.5Fax number+03612033985
    B.5.6E-maildmarchidanu@hungarotrial.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 nameBP05
    D.3.2Product code BP05
    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 codeBP05
    D.3.9.4EV Substance CodeSUB22314
    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 No
    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
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma Stein AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    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 CodeSUB22314
    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 No
    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
    Wet (Neovascular) Age-Related Macular Degeneration
    Vlhká (neovaskulárna) vekom podmienená degenerácia makuly
    E.1.1.1Medical condition in easily understood language
    Wet (Neovascular) Age-Related Macular Degeneration
    Vlhká (neovaskulárna) vekom podmienená degenerácia makuly
    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 LLT
    E.1.2Classification code 10075568
    E.1.2Term Wet age-related macular degeneration
    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 evaluate the efficacy of a biosimilar candidate BP05 versus Lucentis in patients with wAMD
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of BP05 versus Lucentis in patients with wAMD based on CFT, area of CNV, and leakage from CNV lesion
    • To evaluate the systemic exposure of BP05 versus Lucentis in patients participating in PK evaluation
    • To evaluate immunogenicity of BP05 versus Lucentis
    • To evaluate the safety of BP05 versus Lucentis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient or patient’s legally authorized representative is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
    2. Willing and able to undertake all scheduled visits and assessments as judged by the investigator.
    3. Age ≥50 years at Screening.
    4. Patients diagnosed with active* subfoveal CNV lesion secondary to AMD in the study eye.
    *Active CNV means presence of leakage as evidenced by FA and intra/subretinal fluid as evidenced by OCT, which should be confirmed by the central reading center at Screening.
    5. The area of CNV must be ≥50% of the total lesion area in the study eye and confirmed by the central reading center prior to randomization.
    6. Total lesion area ≤12.0 disc areas in size (including blood, scars, and neovascularizati-on) as assessed by FA in the study eye and confirmed by the central reading center prior to randomization.
    7. Best corrected visual acuity of 20/40 to 20/200 in the study eye using ETDRS chart at Screening.
    8. Nonchildbearing potential female (eg, permanently sterilized, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening]), OR Childbearing potential female patients or male patients with their (respectively male or female) partners who agree to use at least 2 forms of appropriate contraception method that can achieve a failure rate of less than 1% per year (as detailed in Appendix 2 [Section 13.2]) from Screening until 3 months after the last IVT injection of the study drug.
    E.4Principal exclusion criteria
    -Sub- or intraretinal hemorrhage involving the fovea in the study eye of 50% or more of the total lesion area assessed by FA and confirmed by central reading center
    -Scarring in the study eye exceeding 50% of total lesion size
    -Subfoveal fibrosis or atrophy in the study eye assessed by FA and confirmed by central reading center
    -Presence of CNV in either eye due to non-AMD causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia, assessed by FA and confirmed by central reading center
    -History or presence of RPE tear or retinal detachment involving the macula in the study eye and fellow eye as assessed by FA and confirmed by central reading center
    -History or presence of macular hole in the study eye at Screening, confirmed by central reading center
    -History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular edema in either eye.
    -History: of vitrectomy surgery, of trabeculectomy or other filtration surgery, of submacular surgery or other surgical intervention for AMD in the study eye.
    -Any other intraocular surgery (including cataract surgery) or periocular surgery in the study eye within 90 days prior to randomization, except for lid surgery, which may not have taken place within 30 days prior to randomization.
    -Any previous IVT anti-VEGF treatment (eg, bevacizumab, aflibercept, ranibizumab) in either eye.
    -Any previous systemic anti-VEGF treatment, within 90 days prior to randomization, and such treatment will not be allowed during the study period.
    -Any systemic treatment or therapy (including prescribed herbal medication) to treat wAMD within 30 days prior to randomization, and such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins, or minerals will be allowed.
    -Any IVT injection of corticosteroid (eg, triamcinolone acetonide) or IVT corticosteroid implant in the study eye within 180 days prior to randomization, and such treatment will not be allowed during the study period.
    -Topical ocular corticosteroids administered for ≥30 consecutive days in the study eye within 90 days prior to Screening.
    -Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia. For patients 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.
    -Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a yttrium aluminium garnet posterior capsulotomy in association with prior posterior chamber intraocular lens implantation.
    -Presence of scleromalacia in either eye.
    -Current vitreous hemorrhage in the study eye.
    -Active or recent (within 28 days prior to randomization) intraocular, extraocular, and periocular inflammation or infection in either eye.
    -History of idiopathic or autoimmune-associated uveitis in either eye.
    -Corneal transplant in the study eye.
    -Presence of advanced glaucoma or optic neuropathy that involve or threaten the central visual field in the study eye.
    -Uncontrolled ocular hypertension in the study eye, defined as IOP ≥30 mmHg despite treatment with antiglaucoma medication.
    -History of allergy to the fluorescein sodium for injection in angiography.
    -Contraindication for any of the excipients in BP05 or Lucentis (active or suspected ocular or periocular infection, or active severe intraocular inflammation).
    -Reasonable suspicion of a disease or condition that might render the patient at high risk of treatment complications or affect interpretation of the study results (as judged by the investigator).
    -Any concurrent ocular condition in the study eye, which in the opinion of the investigator, could either increase the risk to the patient safety or which otherwise may interfere with evaluation of efficacy or safety including, but not limited to ocular media opacities such as corneal opacity or cataract that do not allow proper fundus visualization and fundus imaging, and ocular surface abnormalities, which prevent applanation tonometry during the study period after randomization.
    -Pregnant or lactating women. A urine pregnancy test must be required for women of childbearing potential at Screening and must agree to pregnancy prevention throughout the duration of the study.
    -Stroke, transient ischemic attacks, or myocardial infarction within 90 days prior to randomization.
    -Pharmacokinetic subgroup only: contraindication for additional blood sampling (as judged by the investigator).
    E.5 End points
    E.5.1Primary end point(s)
    • Change in BCVA letters at Week 8, compared with baseline, in the study eye using the ETDRS chart
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 8, compared with baseline
    E.5.2Secondary end point(s)
    • Change in BCVA letters over the course of the study compared with baseline in the study eye using the ETDRS chart
    • Change in total size of CNV leakage area at Week 24 and Week 52 compared with baseline in the study eye, as measured by FA
    • Change in total size of CNV at Week 24 and Week 52 compared with baseline in the study eye, as measured by FA
    • Change in CFT at Week 4, Week 8, Week 16, Week 24, and Week 52 compared with baseline in the study eye, as measured by spectral domain OCT
    • Percentage of patients with loss of ≤15 letters using ETDRS, evaluated as change at Week 8, Week 24, and Week 52 compared with baseline in the study eye
    • Percentage of patients with gain of >15 letters using ETDRS, evaluated as change at Week 8, Week 24, and Week 52 compared with baseline in the study eye
    • Change in intra/subretinal fluid status at Week 24 and Week 52 compared with baseline in the study eye, as measured by OCT
    • Number of patients without intra/subretinal fluid at Week 24 and Week 52 in the study eye
    • Drug concentrations (Cmax) analyzed after the collection of blood at the following time points:
    o Before administration of the study drug at Cycle 1
    o 22 hours ± 1 hour after the administration of the first and the sixth dose
    • Incidence of ADAs to ranibizumab measured at pre-dose on Day 1, Week 4, Week 12, Week 20, Week 36, and Week 52
    • Incidence of NAbs will be performed in all the ADA-positive patients
    • Adverse events, as defined by TEAEs, SAEs, AESIs, related TEAEs, and related SAEs
    • Injection site reactions
    • Intraocular inflammation
    • Laboratory parameters (hematology, clinical chemistry, urinalysis, etc.)
    • Intraocular pressure and perfusion of the optic nerve
    E.5.2.1Timepoint(s) of evaluation of this end point
    on day 1, at Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36 and Week 52 compared with baseline
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    North Macedonia
    Russian Federation
    Bulgaria
    Czechia
    Latvia
    Poland
    Slovakia
    E.8.7Trial has a data monitoring committee No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 550
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 550
    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 Decision2023-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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