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    EudraCT Number:2018-002448-10
    Sponsor's Protocol Code Number:BIA-51058-201
    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:2021-02-01
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-002448-10
    A.3Full title of the trial
    An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH)
    Studio multicentrico in aperto per valutare la farmacocinetica, la sicurezza e l’efficacia di zamicastat come terapia aggiuntiva nell’ipertensione arteriosa polmonare (IAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.
    Studio per trovare il dosaggio di zamicastat più promettente per il trattamento della IAP.
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH
    Farmacocinetica, sicurezza ed efficacia di BIA 5-1058 nella IAP
    A.4.1Sponsor's protocol code numberBIA-51058-201
    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 SponsorBIAL-Portela & Ca, S.A.
    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 supportBial - Portela & Ca, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBial - Portela & Ca, S.A.
    B.5.2Functional name of contact pointDevelopment Department
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. da Siderurgia Nacional
    B.5.3.2Town/ cityCoronado (S. Romão e S. Mamede)
    B.5.3.3Post code4745-457
    B.5.4Telephone number+351229866100
    B.5.5Fax number+351229866192
    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 namezamicastat
    D.3.2Product code [BIA 5-1058]
    D.3.4Pharmaceutical form 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 INNzamicastat
    D.3.9.1CAS number 1080028-80-3
    D.3.9.2Current sponsor codeBIA 5-1058
    D.3.9.4EV Substance CodeSUB192395
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    Pulmonary arterial hypertension
    Ipertensione arteriosa polmonare
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension
    Ipertensione arteriosa polmonare
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the PK profile of different zamicastat doses in PAH patients to find the most promising therapeutic dosage range for the treatment of PAH disease
    L'obiettivo primario di questo studio è quello di valutare il profilo farmacocinetico (PK) di diverse dosi di zamicastat in pazienti affetti da IAP per trovare l’intervallo di dosi terapeutiche più promettente per il trattamento della IAP
    E.2.2Secondary objectives of the trial
    To assess further PK parameters, efficacy, safety and tolerability of different zamicastat doses
    Valutare ulteriori parametri farmacocinetici, l'efficacia, la sicurezza e la tollerabilità di differenti dosi di zamicastat
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 18 to 75 years, inclusive.
    2. Able to comprehend and willing to sign an informed consent form.
    3. Diagnosis of PAH (pulmonary arterial hypertension WHO Group 1), documented by right heart catheterisation with a mean pulmonary artery pressure (mPAP) = 25 mmHg, a pulmonary artery wedge pressure (PAWP) = 15 mmHg and a pulmonary vascular resistance (PVR) > 3 WU [Galie N, et. al 2015; Lau EMT, et. al. 2017]:
    a) Idiopathic, in non-vasoreactive patients
    b) Heritable: Bone morphogenetic protein receptor type II (BMPR2) mutation and other mutations, in non-vasoreactive patients
    c) Drugs and toxin induced, in non-vasoreactive patients
    d) Associated with connective tissue disease
    e) Associated with simple congenital defects (atrial septal defect and/or ventricular septal defect) if closed > 12 months before inclusion.
    4. The patient’s last right heart catheterisation results, which were measured at the study site, must not be older than 90 days before V1 (will be considered as baseline value). Otherwise, a right heart catheterisation has to be performed as part of the study at visit A1.
    5. WHO functional class II or III as judged by the investigator.
    6. Stable treatment with at least one of the following approved PAH therapies for at least 90 days prior to V1: Ambrisentan, Bosentan, Macitentan, Riociguat, Selexipag, Sildenafil, Tadalafil, Epoprostenol intravenous, Iloprost inhaled or Treprostinil intravenous or subcutaneous.
    7. For women: Agree not to donate ova from the time of informed consent until 30 days after the last IMP intake. For men: Agree not to donate sperm from the time of informed consent until 90 days after the last IMP intake.
    1. Pazienti maschi o femmine da 18 a 75 anni di età inclusi.
    2. In grado di comprendere e disposti a firmare un modulo di consenso informato.
    3. Diagnosi di IAP (ipertensione arteriosa polmonare, Gruppo 1 dell’OMS), documentata mediante cateterismo cardiaco destro con una pressione arteriosa polmonare media (PAPm) = 25 mmHg, una pressione capillare polmonare (PAWP) = 15 mmHg e una resistenza vascolare polmonare (PVR) > 3 WU [Galie N, et al. 2015; Lau EMT, et al. 2017]:
    a) Idiopatica, in pazienti non vasoreattivi
    b) Ereditaria: Mutazione del recettore della proteina morfogenetica dell’osso di tipo II (BMPR2) e altre mutazioni, in pazienti non vasoreattivi
    c) Indotta da farmaci e tossine, in pazienti non vasoreattivi
    d) Associata a malattia del tessuto connettivo
    e) Associata a difetti congeniti semplici (difetto del setto interatriale e/o difetto del setto interventricolare) con chiusura > 12 mesi prima dell’inclusione.
    4. I risultati dell’ultimo cateterismo cardiaco destro del paziente, che sono stati misurati presso il centro di studio, non dovranno risalire a più di90 giorni prima della V1(sarà considerato come valore basale). Altrimenti, dovrà essere eseguito un cateterismo cardiaco destro come parte dello studio alla visita A1.
    5. Classe funzione II o III dell'OMS, a giudizio dello sperimentatore.
    6. Trattamento stabile con almeno una delle seguenti terapie i approvate per l’IAP per almeno 90 giorni prima della V1: ambrisentan, bosentan, macitentan, riociguat, selexipag, sildenafil, tadalafil, epoprostenolo intravenoso, iloprost inalatorio o treprostinil intravenoso o sottocutaneo.
    7. Per le donne: essere d’accordo a non donare ovuli dal momento del consenso informato fino a 30 giorni dopo l’ultima assunzione dell’IMP. Per gli uomini: essere d’accordo a non donare sperma dal momento del consenso informato fino a 90 giorni dopo l’ultima assunzione dell’ IMP.
    E.4Principal exclusion criteria
    1. Two or more consecutive measurements of SBP < 95 mmHg or DBP < 50 mmHg measured at V1. 2. Two or more consecutive measurements of SBP < 95 mmHg or DBP < 50 mmHg. 3. Uncontrolled diabetes mellitus with HbA1c = 8.5% within the last three months or at screening. 4. PAH WHO Group 1 due to portal hypertension, HIV infection and schistosomiasis.5. Any disease known to cause pulmonary hypertension other than PAH WHO Group 1. 6. Obstructive lung disease: FEV1/FVC < 60% and FEV1 < 60% of predicted value after bronchodilator administration, as demonstrated and documented by previous spirometry data which, in the opinion of the investigator, represent the clinical state of the patient at the time of the screening visit. 7. Restrictive lung disease: Total Lung Capacity (TLC) < 70% of predicted value, as demonstrated and documented by previous spirometry data which, in the opinion of the investigator, represent the clinical state of the patient at the time of the screening visit. 8. History of moderate to severe hepatic impairment (Child-Pugh B and C). 9. eGFR < 30 mL/min/1.73 m2 (at V1).
    10. Use of the following prohibited medication or treatments during study participation: CCBs if used for the treatment of PAH in vasoreactive patients; drugs containing a catechol group that is metabolised by DßH e.g. rimiterole, isoprenaline, dopamine, dopexamine or dobutamide or a- and/or ß-blockers. 11. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine. 12. Presence of any other significant or progressive/unstable medical condition that, in the opinion of the investigator, would compromise evaluation of the study treatment or may jeopardise the patient’s safety, compliance or adherence to protocol requirements. 13. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice highly effective contraceptive measures in combination with a barrier method e.g. condom, occlusive cap with spermicidal gel/film/cream/suppository from the time of informed consent until 30 days after last IMP intake. Highly effective methods for women are surgical intervention, non-hormonal implantable intrauterine device, true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient) and vasectomised partner (provided that the partner is the sole sexual partner of the patient and the partner has received medical assessment of the surgical success). Periodic abstinence (e.g. calendar, ovulation,
    symptothermal, post-ovulation methods), hormonal contraceptives and withdrawal are not acceptable methods of contraception. For men: Male patients who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved acceptable contraceptive measure from the time of informed consent until 90 days after the last IMP intake. The following methods are acceptable methods of contraception: partner’s use of combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); partner’s use of progestogen-only hormonal contraception (oral, injectable/implantable, intrauterine hormone-releasing system); partner’s use of implantable intrauterine device; surgical sterilisation (for example, vasectomy or bilateral tubal occlusion).
    14. Previous participation in any other drug investigational study within the past 30 days (or five half-lives of investigational medicinal product [IMP] whichever is longer) prior to V1.
    15. Vulnerable patients according to Section 1.61 of the ICH guideline for Good Clinical Practice E6.
    1. Controindicazione a zamicastat, ossia sensibilità nota ai componenti della formulazione di zamicastat. 2. Due o più misurazioni consecutive di SBP < 95 mmHg o DBP < 50 mmHg misurate alla V1 3. Diabete mellito non controllato con HbA1c = 8.5% negli ultimi tre mesi o allo screening. 4. IAP Gruppo 1 dell’OMS, dovuta a ipertensione portale, infezione da HIV e schistosomiasi. 5. Qualsiasi patologia nota causa di ipertensione polmonare diversa da IAP Gruppo 1 dell’OMS. 6. Malattia polmonare ostruttiva: FEV1/FVC < 60% e FEV1 < 60% del valore predetto in seguito a somministrazione di un broncodilatatore, come dimostrato e documentato da precedenti dati spirometrici che, secondo il giudizio dello sperimentatore, rappresentano lo stato clinico del paziente al momento della V1. 7. Malattia polmonare restrittiva: TLC <70% del valore predetto come dimostrato e documentato da precedenti dati spirometrici che, secondo il giudizio dello sperimentatore, rappresentano lo stato clinico del paziente al momento della V1. 8. Anamnesi positiva per compromissione epatica da moderata a grave (Child-Pugh B e C). 9. eGFR < 30 ml/min/1,73 m2 (alla V1). 10. Uso dei seguenti farmaci o trattamenti vietati durante la partecipazione allo studio: CCB se impiegati per il trattamento dell’IAP in pazienti vasoreattivi; farmaci contenenti un gruppo catecolico metabolizzato da DßH o a- e/o ß-bloccanti. 11. Attuale o precedente (nel corso dell'ultimo anno) abuso di alcol o sostanze, esclusa caffeina o nicotina. 12. Presenza di qualsiasi altra condizione clinica significativa o progressiva/instabile che a parere dello sperimentatore comprometterebbe la valutazione del trattamento sperimentale o potrebbe mettere a rischio la sicurezza del paziente, la conformità o l'aderenza ai requisiti del protocollo.13. Per le donne: Gravidanza o allattamento. Donne potenzialmente fertili non in grado o non disposte a sottoporsi ai test di gravidanza e a praticare misure contraccettive altamente efficaci in combinazione con un metodo di barriera ad es. preservativo, cappuccio occlusivo con gel /film/crema/supposta spermicida dal momento del consenso informato fino a 30 giorni dopo l’ultima somministrazione dell’IMP. Metodi altamente efficaci per le donne sono intervento chirurgico, dispositivo intrauterino impiantabile non ormonale, reale astinenza sessuale (se ciò è in linea con lo stile di vita preferito e abituale della paziente) e partner vasectomizzato (a condizione che il partner sia l'unico partner sessuale del paziente e che il partner abbia ricevuto una valutazione medica del successo chirurgico). L'astinenza periodica (ad es. metodi del calendario, dell'ovulazione, sintotermico, post-ovulazione), contraccettivi ormonali e il coito interrotto non sono metodi di contraccezione accettabili. Per gli uomini: i pazienti di sesso maschile che sono sessualmente attivi con un partner in età potenzialmente fertile devono utilizzare, con il loro partner, un preservativo più una misura contraccettiva accettabile approvata dal momento del consenso informato fino a 90 giorni dopo l'ultima assunzione di IMP. I seguenti metodi sono metodi contraccettivi accettabili: l'uso da parte del partner di contraccettivi ormonali combinati (contenenti estrogeno e progesterone) associati all'inibizione dell'ovulazione (orale, intra vaginale, transdermica); l'uso da parte dei partner della contraccezione ormonale solo a base di progesterone (orale, iniettabile / impiantabile, sistema di rilascio di ormone intrauterino); l'uso da parte del partner del dispositivo intrauterino impiantabile; sterilizzazione chirurgica (per esempio vasectomia o occlusione tubarica bilaterale). 14. Precedente partecipazione ad altra sperimentazione farmacologica negli ultimi 30 giorni (o cinque emivite del medicinale sperimentale [IMP], a seconda del periodo più lungo) prima della V1. 15. Pazienti vulnerabili, secondo la sezione 1.61 delle linee guida ICH di buona pratica clinica E6.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate pharmacokinetic (PK) profile of different zamicastat doses in PAH patients to find the most promising therapeutic dosage range for the treatment of PAH disease
    Valutare il profilo farmacocinetico (PK) di diverse dosi di zamicastat in pazienti affetti da IAP, per trovare l’intervallo di dosi terapeutiche più promettente per il trattamento della IAP
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once the last PK sample of the last patient has been analysed.
    Dopo che l'ulimo campione di PK dell'ultimo paziente è stato analizzato.
    E.5.2Secondary end point(s)
    To assess further PK parameters, efficacy, safety and tolerability of different zamicastat doses
    Valutare ulteriori parametri di farmacocinetica, efficacia, sicurezza e tollerabilità di diverse dosi di zamicastat
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once the last PK, efficacy, safety and tolerability parameters of the last patient has been analysed.
    Dopo che gli ultimi parametri di PK, efficacia, sicurezza e tollerabilità dell'ultimo paziente sono stati analizzati.
    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 Yes
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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. 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 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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    United Kingdom
    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
    Ultima visita dell'ultimo soggetto
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 35
    F.4.2.2In the whole clinical trial 40
    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)
    At the end of the maintenance period, the patient will have the opportunity to continue treatment in an extension study (BIA-51058-202), which will be described in a separate protocol.
    Al termine del periodo di mantenimento, il paziente avrà l'opportunità di continuare il trattamento in uno studio di estensione (BIA-51058-202), che sarà descritto in un protocollo separato.
    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 Decision2019-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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