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    Summary
    EudraCT Number:2020-004523-16
    Sponsor's Protocol Code Number:GR42691
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-004523-16
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL EXTENSION
    STUDY TO EVALUATE THE LONG-TERM SAFETY
    AND TOLERABILITY OF FARICIMAB IN PATIENTS
    WITH NEOVASCULAR AGE-RELATED MACULAR
    DEGENERATION
    STUDIO DI ESTENSIONE, MULTICENTRICO E IN APERTO VOLTO A VALUTARE LA SICUREZZA E LA TOLLERABILITÀ A LUNGO TERMINE DI FARICIMAB IN PAZIENTI CON DEGENERAZIONE MACULARE DI TIPO NEOVASCOLARE LEGATA ALL’ETÀ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients with Neovascular Age-Related Macular Degeneration
    UNO STUDIO PER VALUTARE LA SICUREZZA E LA TOLLERABILITÀ A LUNGO TERMINE DI FARICIMAB IN PAZIENTI CON DEGENERAZIONE MACULARE DI TIPO NEOVASCOLARE LEGATA ALL’ETÀ
    A.3.2Name or abbreviated title of the trial where available
    AVONELLE
    AVONELLE
    A.4.1Sponsor's protocol code numberGR42691
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann La-Roche Ltd - Basel
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche LTD
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameFaricimab
    D.3.2Product code [RO6867461/F06]
    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 INNFaricimab
    D.3.9.1CAS number 1607793-29-2
    D.3.9.2Current sponsor codeRO6867461
    D.3.9.3Other descriptive nameVA2, VEGF-Ang2 ophtha Humanized anti-VEGF-A anti-Ang-2 bispecific Antibody
    D.3.9.4EV Substance CodeSUB126170
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Neovascular age-related macular degeneration (nAMD)
    Degenerazione maculare di tipo neovascolare legata all’età
    E.1.1.1Medical condition in easily understood language
    Neovascular age-related macular degeneration (nAMD), also known as wet AMD, is a medical condition which may result in distortion and potentially irreversible loss of the central vision
    La degenerazione maculare neovascolare correlata all'età, è una condizione medica che può provocare una distorsione e una perdita potenzialmente irreversibile della visione centrale
    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 10025410
    E.1.2Term Macular degeneration (senile) of retina, unspecified
    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 long-term ocular and systemic safety and tolerability of faricimab administered intravitreally in patients with nAMD
    L’obiettivo primario consiste nel valutare la sicurezza e la tollerabilità oculari e sistemiche a lungo termine di faricimab in tutti i pazienti arruolati nello studio di estensione a lungo termine
    E.2.2Secondary objectives of the trial
    NOT APPLICABLE
    na
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: The parent TWIN studies have protocol numbers GR40306 and GR40844.
    Patients from these studies who meet criteria will enroll into the current
    study-GR42691.
    1) GR40844- A PHASE III, MULTICENTER, RANDOMIZED, DOUBLEMASKED,
    ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE
    EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH
    NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (LUCERNE).
    Protocol date: 2018-11-20; Objective- To evaluate the efficacy of IVT
    (intravitreal) injections of faricimab on change in best-corrected visual
    acuity (BCVA)
    2) GR40306-A PHASE III, MULTICENTER, RANDOMIZED, DOUBLEMASKED,
    ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE
    EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH
    NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (TENAYA);
    Protocol date: 2018-11-20; Objective- To evaluate the efficacy of IVT
    (intravitreal) injections of faricimab on change in best-corrected visual
    acuity (BCVA)

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: The parent TWIN studies have protocol numbers GR40306 and GR40844.
    Patients from these studies who meet criteria will enroll into the current
    study-GR42691.
    1) GR40844- A PHASE III, MULTICENTER, RANDOMIZED, DOUBLEMASKED,
    ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE
    EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH
    NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (LUCERNE).
    Protocol date: 2018-11-20; Objective- To evaluate the efficacy of IVT
    (intravitreal) injections of faricimab on change in best-corrected visual
    acuity (BCVA)
    2) GR40306-A PHASE III, MULTICENTER, RANDOMIZED, DOUBLEMASKED,
    ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE
    EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH
    NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (TENAYA);
    Protocol date: 2018-11-20; Objective- To evaluate the efficacy of IVT
    (intravitreal) injections of faricimab on change in best-corrected visual
    acuity (BCVA)
    E.3Principal inclusion criteria
    • Previous enrollment in and completion of Study GR40306 (TENAYA) or Study GR40844 (LUCERNE), without study or study drug discontinuation
    • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 3 months after the final dose of faricimab. Women must refrain from donating eggs during the same period.
    ¿ Precedente arruolamento e completamento dello studio GR40306 (TENAYA) o GR40844 (LUCERNE), senza interruzione dello studio o del trattamento con il farmaco in studio.
    ¿ Sottoscrizione del modulo di consenso informato.
    ¿ Capacità di rispettare il protocollo dello studio secondo il parere dello sperimentatore.
    ¿ Per le donne in età fertile: consenso a praticare l’astinenza dai rapporti eterosessuali o ad adottare metodi contraccettivi e consenso ad astenersi dalla donazione degli ovuli, secondo quanto definito di seguito:
    Le donne dovranno praticare l’astinenza o adottare metodi contraccettivi con tasso di insuccesso ¿ 1% all’anno durante il periodo di trattamento e per 3 mesi dopo l’ultima dose di faricimab. Nel corso del medesimo periodo, le donne dovranno astenersi dalla donazione degli ovuli.
    Con “in età fertile” si intendono donne in cui è già comparso il menarca ma che non sono ancora in stato postmenopausale (= 12 mesi consecutivi di amenorrea senza identificazione di cause diverse dalla menopausa) e non soggette a infertilità permanente per intervento chirurgico (asportazione delle ovaie, delle tube di Falloppio e/o dell’utero) o per altre cause determinate dallo sperimentatore (per es. agenesia mülleriana). La definizione di “in età fertile” potrà essere adattata ai fini dell’allineamento con le linee guida o le normative locali.
    Tra gli esempi di metodi contraccettivi con tasso di insuccesso ¿ 1% all’anno si annoverano chiusura bilaterale delle tube, vasectomia, uso di contraccettivi ormonali che inibiscono l’ovulazione e dispositivi intrauterini a rilascio di ormoni e in rame.
    L’affidabilità dell’astinenza sessuale dovrà essere valutata in relazione alla durata della sperimentazione clinica e allo stile di vita preferito e abituale della paziente. L’astinenza periodica (per es. metodo del calendario, dell’ovulazione, sintotermico o post-ovulazione) e il coito interrotto non sono ritenuti metodi contraccettivi adeguati. Se richiesto dalle linee guida o dalle normative locali, nel modulo di consenso informato locale verranno illustrati i metodi contraccettivi adeguati localmente riconosciuti e le informazioni sull’affidabilità dell’astinenza.
    E.4Principal exclusion criteria
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final dose of faricimab
    • Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
    • Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
    • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study-related procedure preparations, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
    • Requirement for continuous use of any medications or treatments indicated as prohibited therapy
    ¿ Gravidanza o allattamento o intenzione di iniziare una gravidanza durante lo studio o nei 28 giorni successivi l’ultima dose di faricimab.
    Le donne in età fertile dovranno ottenere un risultato negativo al test di gravidanza sulle urine nei 28 giorni precedenti l’inizio del trattamento in studio. Se il test di gravidanza sulle urine risulterà positivo, l’esito dovrà essere confermato da un test di gravidanza sul siero.
    ¿ Presenza di altre patologie dell’occhio che suscitano il ragionevole sospetto di una malattia o condizione che rappresenta una controindicazione all’uso di faricimab, che potrebbe interferire con l’interpretazione dei risultati dello studio o che espone il paziente ad alto rischio di complicanze correlate al trattamento.
    ¿ Presenza di altre patologie, disfunzioni metaboliche o referti di laboratorio che suscitano il ragionevole sospetto di una malattia o condizione che rappresenta una controindicazione all’uso di faricimab, che potrebbe interferire con l’interpretazione dei risultati dello studio o che espone il paziente ad alto rischio di complicanze correlate al trattamento.
    ¿ Anamnesi positiva per reazione allergica severa o reazione anafilattica a un agente biologico, oppure ipersensibilità nota a uno qualsiasi dei componenti delle iniezioni di faricimab, delle preparazioni per le procedure correlate allo studio (fluoresceina compresa), dei colliri midriatici o delle preparazioni anestetiche e antimicrobiche usate dal paziente durante la sperimentazione.
    ¿ Necessità di un utilizzo continuo di farmaci o trattamenti indicati come terapie non ammesse.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of ocular adverse events
    2. Incidence and severity of systemic (non-ocular) adverse events
    1. Incidenza e gravità degli eventi avversi oculari
    2. Incidenza e gravità degli eventi avversi sistemici (non oculari)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Approximately 104 weeks
    1-2. Circa 104 settimane
    E.5.2Secondary end point(s)
    Not applicable
    na
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    na
    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
    Biomarker
    Immunogenicità Biomarker
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Designo in doppio cieco mascherato per i primi 3 mesi, seguito da designo in aperto.
    First 3 months masked double blind design , followed by open label design.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Hong Kong
    Korea, Republic of
    Russian Federation
    Singapore
    Taiwan
    Turkey
    United States
    Austria
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Spain
    United Kingdom
    Argentina
    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
    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 years3
    E.8.9.2In all countries concerned by the trial months3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1180
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 335
    F.4.2.2In the whole clinical trial 1280
    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)
    Please refer to section 4.3.4 of protocol
    Fare riferimento alla sezione 4.3.4 del protocollo
    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 Decision2021-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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