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    Summary
    EudraCT Number:2020-002333-15
    Sponsor's Protocol Code Number:20739
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2020-002333-15
    A.3Full title of the trial
    A Phase 2 randomized, placebo-controlled, double-masked proof-of-concept and dose-finding study to investigate the efficacy and safety of runcaciguat (BAY 1101042) in patients with moderately severe to severe non-proliferative diabetic retinopathy
    Studio randomizzato, controllato con placebo, in doppio cieco, di fase 2, proof-of-concept, di individuazione del dosaggio per la valutazione dell’efficacia e della sicurezza di runcaciguat (BAY 1101042) in pazienti affetti da retinopatia diabetica non proliferante da moderatamente grave a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Non-proliferative diabetic retinopathy treated with runcaciguat
    Retinopatia diabetica non proliferante trattata con runcaciguat
    A.3.2Name or abbreviated title of the trial where available
    NEON-NPDR
    NEON-NPDR
    A.4.1Sponsor's protocol code number20739
    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 SponsorBAYER AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref: 'EU CTR' /Bayer AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayer.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 nameBAY1101042 sodium modifiedrelease coated 15mg GITS
    D.3.2Product code [BAY1101042]
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNruncaciguat
    D.3.9.2Current sponsor codeBAY 1101042
    D.3.9.4EV Substance CodeSUB46088
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - Non-proliferative diabetic retinopathy: early stage of a medical condition in which damage occurs to the retina due to diabetes mellitus (DM)
    - DM is characterized by too much sugar in the blood
    Retinopatia diabetica non proliferante da moderatamente grave a grave
    E.1.1.1Medical condition in easily understood language
    Non-proliferative diabetic retinopathy
    Retinopatia diabetica non proliferante
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: To establish the proof-of-concept for the efficacy of runcaciguat in the treatment of NPDR
    Part B: To determine the dose level with best benefit-risk profile
    Parte A: Determinazione di una proof-of-concept relativa all’efficacia di runcaciguat nel trattamento della NPDR
    Parte B: Determinazione del livello di dosaggio con il miglior profilo rischi/benefici
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of runcaciguat in patients with NPDR
    Studio della sicurezza e della tollerabilità di runcaciguat nei pazienti con NPDR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53
    2. Diabetes type 1 or 2
    3. Best corrected visual aquity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of =69 letters (approximate Snellen equivalent of 20/40 or better)
    1. Il partecipante deve essere di età >/=18 anni al momento della firma del modulo di consenso informato.
    Tipo di partecipante e caratteristiche della malattia
    2. NPDR da moderatamente grave a grave nell’occhio oggetto di studio: livelli del punteggio DRSS 47 o 53
    3. Diabete di tipo 1 o 2
    4. BCVA dell’occhio oggetto di studio, misurata mediante tavola ETDRS, =69 lettere (equivalente Snellen di circa 20/40 o più)
    5. Rifrazione con equivalente sferico compreso tra -6 dpt e +5 dpt
    Sesso e requisiti relativi a misure/barriere contraccettive
    6. Pazienti di sesso maschile e/o femminile
    Il metodo contraccettivo utilizzato dai pazienti di sesso maschile o femminile deve essere conforme alle normative locali in materia di contraccezione per i partecipanti a studi clinici. I partecipanti di sesso maschile devono acconsentire a utilizzare preservativi dal momento in cui firmano il modulo di consenso informato fino al termine del periodo di studio. Le partecipanti di sesso femminile non devono essere in età fertile oppure devono utilizzare un metodo contraccettivo altamente efficace (vedere la Sezione 10.4). Tale requisito si applica dal momento in cui i partecipanti firmano il modulo di consenso informato fino al termine del periodo di studio.
    Consenso informato
    7. Capacità di fornire il consenso informato firmato, come descritto nella Sezione 10.1.3, che include la conformità ai requisiti e alle restrizioni elencati nel modulo di consenso informato (ICF) e nel presente protocollo
    E.4Principal exclusion criteria
    1. Presence or history of macular edema involving the center of the macula
    2. Any kind of neovascular growth in the study eye, including anterior segment neovascularization
    3. Arterial hypotension with systolic blood pressure < 100 or diastolic blood pressure < 60mmHg
    4. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 3 x Upper limit of normal (ULN) or bilirubin = 1.5 ULN at screening or Day 1, known ascites
    5. Estimated glomerular filtration rate (eGFR CKD-EPI) below 45 ml/min/1.73 m^2 at screening
    6. Any prior systemic anti-Vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye
    7. Any prior intraocular steroid injection in the study eye
    8. Any prior grid or focal laser photocoagulation within 500 microns of the foveal center or any prior Pan-retinal photocoagulation (PRP) in the study eye
    9. Use of nitrates or Nitric oxide (NO) donors (such as amyl nitrate) in any form including topical; Phosphodiesterase 5 (PDE5) inhibitors, non-specific PDE inhibitors within 1 week before first study drug administration
    Condizioni cliniche
    1. Diabete mellito non controllato definito mediante valori di HbA1c pari o superiori al 10,0% durante lo screening
    2. Patologia oculare in grado di interferire in modo significativo con gli esami del fondo oculare dell’occhio oggetto di studio
    3. Glaucoma nell’occhio oggetto di studio
    4. Dilatazione della pupilla <5 mm nell’occhio oggetto di studio
    5. Infiammazione oculare (tracce o estensione maggiore) oppure congiuntivite durante lo screening oppure uveite in anamnesi nell’occhio oggetto di studio
    6. Presenza o anamnesi di edema maculare che coinvolga il centro della macula (definito come l’area del sottocampo centrale determinata mediante OCT) nell’occhio oggetto di studio
    7. Qualsiasi tipo di crescita neovascolare nell’occhio oggetto di studio, compresa la neovascolarizzazione del segmento anteriore
    8. Anamnesi o presenza di patologie retiniche vascolari o neurodegenerative nell’occhio oggetto di studio, compresa la retinopatia ipertensiva di grado III o IV
    9. Un solo occhio funzionale
    10. Arteriopatia occlusiva sintomatica (compresa arteriopatia occlusiva periferica), cardiopatia coronarica (ad es. angina pectoris, infarto del miocardio), patologia cerebrovascolare (ad es. attacco ischemico transitorio, ictus), stenosi aortica clinicamente significativa o stenosi arteriosa renale, nei 6 mesi precedenti la visita di screening
    11. Trombosi venosa profonda nei 6 mesi precedenti la visita di screening
    12. Eventi tromboembolici (ad es. embolia arteriosa acuta, embolia polmonare o ictus) nei 6 mesi precedenti la visita di screening
    13. Insufficienza cardiaca di classe III o IV secondo la classificazione della New York Heart Association
    14. Storia di aritmia cardiaca clinicamente rilevante (ad es. fibrillazione atriale, blocco atrioventricolare di grado II o III, sindrome di Wolff-Parkinson-White, sindrome del seno malato, bradicardia <45 bpm a riposo, tachicardia >100 bpm a riposo)
    15. Ipotensione arteriosa con pressione arteriosa sistolica <100 mmHg o pressione arteriosa diastolica <60 mmHg;
    16. Ipertensione arteriosa non controllata, definita come pressione arteriosa sistolica >160 mmHg o pressione arteriosa diastolica >100 mmHg
    17. ALT o AST superiore a 3 × ULN o bilirubina =1,5 × ULN durante lo screening, asciti note
    18. Velocità di filtrazione glomerulare stimata (eGFR calcolata mediante formula CKD-EPI) inferiore a 45 ml/min/1,73 m2 allo screening
    19. Ipertensione polmonare nota associata a polmonite interstiziale idiopatica
    20. Allergie rilevanti o ipersensibilità a farmaci o eccipienti somministrati nell’ambito dello studio, ad es. intolleranza ereditaria al galattosio, deficit assoluto di lattasi o malassorbimento di glucosio-galattosio, allergia allo iodio
    21. Qualsiasi risultato degli esami medici o elemento della storia clinica che, secondo il parere dello sperimentatore, induce a sospettare la presenza di una patologia o una condizione che renda sconsigliabile il trattamento con il farmaco sperimentale oppure che possa influenzare l’interpretazione dei risultati dello studio o esporre il paziente a un rischio elevato di complicanze correlate al trattamento
    Terapie precedenti/concomitanti
    22. Qualsiasi precedente trattamento sistemico anti-VEGF o terapia intravitreale anti-VEGF nell’occhio oggetto di studio
    23. Qualsiasi precedente iniezione intraoculare di steroidi nell’occhio oggetto di studio
    24. Qualsiasi precedente fotocoagulazione laser focale o a griglia a meno di 500 micron dal centro della fovea o qualsiasi precedente trattamento con PRP nell’occhio oggetto di studio
    ... (per i rimanent Criteri di Esclusione dal 25 al 34 si rimanda alla SINOSSI in ITALIANO del Protocollo)
    E.5 End points
    E.5.1Primary end point(s)
    Diabetic Retinopathy Severity Scale (DRSS) improvement =2 steps at 24 Weeks of treatment
    Miglioramento del punteggio DRSS per l’occhio oggetto di studio =2 punti a 24 settimane di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after treatment
    24 settimane dopo trattamento
    E.5.2Secondary end point(s)
    Vision threatening complications at 48, 72 and 96 weeks of treatment
    DRSS improvement =2 steps at 48, 72 and 96 Weeks of treatment
    Frequency of treatment emergent adverse events
    • Complicanze per l’occhio oggetto di studio che rischiano di compromettere la vista a 48, 72 e 96 settimane di trattamento
    • Miglioramento del punteggio DRSS per l’occhio oggetto di studio = 2 punti a 48, 72 e 96 settimane di trattamento
    . Frequenza eventi avversi emergenti dal trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 48, 72 and 96 weeks of treatment
    at 48, 72 and 96 weeks of treatment
    from first administration till 28 days after the last dose of the treatment
    a 48, 72 e 96 settimane di trattamento
    a 48, 72 e 96 settimane di trattamento
    dalla prima somministrazione fino a 28 giorni dopo ultima dose di trattamento
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 EEA46
    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
    Denmark
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Switzerland
    United Kingdom
    Czechia
    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 as a whole is defined as the date of the last visit of the last subject in the study in all sites and in all participating countries (EU and non-EU).
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days15
    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: 232
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 290
    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
    NA
    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 Decision2021-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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