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    Summary
    EudraCT Number:2018-004489-32
    Sponsor's Protocol Code Number:KVD900-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-004489-32
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II
    Uno studio randomizzato, in doppio cieco, controllato con placebo, di fase II, in crossover, per valutare l’efficacia e la sicurezza di KVD900, inibitore del kallikrein del plasma orale, nel trattamento su richiesta di attacchi di angioedema in soggetti adulti con angioedema ereditario di tipo I o II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Uno studio per a) valutare la tollerabilità e i livelli ematici di KVD900 quando somministrato come dose singola ai pazienti e b) per valutare se KVD900 è efficace nel trattamento di attacchi di gonfiore nei pazienti con la malattia genetica , angioedema ereditario.
    A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.
    A.3.2Name or abbreviated title of the trial where available
    KVD900-201
    KVD900-201
    A.4.1Sponsor's protocol code numberKVD900-201
    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 SponsorKalVista Pharmaceuticals Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportkalvista Pharmaceuticals
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrion Clinical Services Limited
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street Address7 Bath Road
    B.5.3.2Town/ citySlough
    B.5.3.3Post codeSL1 3UA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441753578080
    B.5.5Fax number00441753578081
    B.5.6E-mailregulatoryuk@orioncro.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 nameKVD900 100 mg Film Coated Tablet
    D.3.2Product code [KVD900 100 mg Film Coated Tablet]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeKVD900
    D.3.9.4EV Substance CodeKVD900
    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.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 placeboFilm-coated 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
    Hereditary Angioedema Type I or II
    Angioedema Ereditario di tipo I e II
    E.1.1.1Medical condition in easily understood language
    Hereditary Angioedema is a genetic condition characterised by swelling of tissues. These swellings can occur on any part of the body.
    L' Angioedema ereditario è una condizione genetica caratterizzata da gonfiore dei tessuti. Questi gonfiori possono verificarsi su qualsiasi parte del corpo.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10019860
    E.1.2Term Hereditary angioedema
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of KVD900 compared to placebo in halting the progression of attacks of HAE
    Indagare l'efficacia di KVD900 rispetto al placebo nel fermare la progressione degli attacchi di HAE
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of KVD900
    To investigate the pharmacokinetic (PK) profile of KVD900
    To investigate the pharmacodynamic (PD) profile of KVD900
    Studiare la sicurezza e la tollerabilità di KVD900
    Indagare il profilo farmacocinetico (PK) di KVD900
    Indagare il profilo farmacodinamico (PD) di KVD900
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female adult subjects 18 years of age and older.
    2. Confirmed diagnosis of HAE type I or II at anytime in the medical history
    3. At least 3 documented HAE attacks in the past 93 days, as supported by medical history.
    4. Access to and ability to use conventional attack treatment for attacks of HAE.
    5. Adequate organ functions as defined below:
    a. Hemoglobin within normal range;
    b. International normalized ratio (INR)< 1.2;
    c. Activated partial thromboplastin time (aPTT) = upper limit of normal (ULN);
    d. Creatinine < 1.0 x ULN;
    e. Creatinine clearance (CrCl) = 60 mL/min;
    f. Alanine aminotransferase (ALT) = 2x ULN;
    g. Aspartate aminotransferase (AST) = 2x ULN;
    h. Total bilirubin = 1.5x ULN;
    i. Leucocytes = 1.5x ULN;
    j. Thrombocytes = 1.5x ULN.
    6. Females of childbearing potential must agree to use highly effective birth control from the last menstrual cycle prior to the start of the study drug until the end of the trial follow-up procedures.
    7. Females of non-childbearing potential, defined as surgically sterile or post-menopausal for at least 12 months, do not require contraception during the study.
    8. Males with female partners of childbearing potential must agree to be abstinent or else use a medically acceptable form of contraception from the Screening visit through until the end of the trial follow-up procedures. Female partners of males who are surgically sterile, must agree to use one additional form of medically acceptable contraception.
    9. Provide signed informed consent and are willing and capable of complying with study requirements and procedures.
    1. Soggetti adulti, uomini o donne, di età pari o superiore ai 18 anni.
    2. Diagnosi confermata di HAE di tipo I o II in qualunque momento della storia medica:
    a. Storia clinica documentata compatibile con HAE (sottocutanea o muscolare, episodi di gonfiore senza prurito senza orticaria concomitante) E
    b. antigene o livello funzionale dell'inibitore della C1-esterasi (C1-INH) inferiore al 40% del livello normale. Soggetti con livello di antigene o C1-INH funzionale pari al 40-50% del livello normale possono essere arruolati se hanno anche un livello di C4 al di sotto del range normale e una storia familiare coerente con HAE di tipo I o II.
    3. Almeno 3 attacchi di HAE documentati negli ultimi 93 giorni, in base alla storia medica.
    4. Accesso e capacità di utilizzare trattamenti tradizionali per attacchi di HAE.
    5. Funzioni di organo adeguate come definite di seguito:
    a. Emoglobina entro i limiti del normale
    b. International normalized ratio (INR)< 1.2;
    c. Tempo parziale di tromboplastina attivata (aPTT) = limite superiore della norma (ULN)
    d. Creatinina < 1.0 x ULN;
    e. Clearance della creatinina (CrCl) = 60 mL/min
    f. Alanino Aminotrasferasi (ALT) = 2x ULN
    g. Aspartato aminotrasferasi (AST) = 2x ULN
    h. Bilirubina Totale = 1.5x ULN
    i. Leucociti = 1.5x ULN
    j. Trombociti = 1.5x ULN
    6. Le donne potenzialmente fertili dovranno accettare di utilizzare un metodo contraccettivo di elevata efficacia dalla visita di screening fino al termine delle procedure di follow-up.
    Metodi contraccettivi altamente efficaci comprendono:
    a) Contraccezione ormonale con solo progesterone associata a inibizione dell’ovulazione: orale, iniettabile, impiantabile. (Contraccettivi ormonali che contengano estrogeni sono esclusi in base al criterio di esclusione 3).
    b) Dispositivo intrauterino (IUD).
    c) Sistema di rilascio ormonale intrauterino (IUS).
    d) Occlusione bilaterale delle tube.
    e) Partner vasectomizzato (quando il partner sia il solo partner sessuale del soggetto donna potenzialmente fertile e il partner possa dimostrare la valutazione medica del successo dell’intervento).
    f) Astinenza sessuale (questo metodo non è accettabile in Svizzera).
    Nota: l'astinenza sessuale sarà considerata un metodo altamente efficace se verrà definita come astensione dal rapporto eterosessuale. L'affidabilità dell'astinenza sessuale deve essere valutata in relazione alla durata della sperimentazione clinica e allo stile di vita preferito e abituale del soggetto.
    7. Donne non potenzialmente fertili, definite come chirurgicamente sterili (post isterectomia, ooforectomia bilaterale o legamento bilaterale delle tube) o in post menopausa da almeno 12 mesi, non richiedono contraccezione durante lo studio.
    8. Gli uomini con partner donne potenzialmente fertili devono accettare l’astinenza oppure adottare un metodo di contraccezione altamente efficace, come definito nel criterio di inclusione 6 dalla visita di screening fino al termine delle procedure di follow-up.
    9. Fornire un consenso informato firmato e disponibili e capaci di rispettare i requisiti e le procedure dello studio.
    E.4Principal exclusion criteria
    1. Any concomitant diagnosis of another form of chronic angioedema,
    such as acquired C1 inhibitor deficiency, HAE with normal C1-INH
    (also known as HAE type III), idiopathic angioedema, or
    angioedema associated with urticaria.
    2. Current use of C1INH, androgens, lanadelumab or tranexamic acid for HAE prophylaxis.
    3. Use of angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 93 days prior to initial study treatment.
    4. Use of androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterones, testosterone) or antifibrinolytics within 30 days prior to initial study treatment.
    5. Use of lanadelumab within 10 weeks prior to initial study treatment
    6. Use of strong CYP3A4/CYP2C9 inhibitors and inducers during participation in the trial.
    Note: These medications include but are not limited to the following: cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole, voriconazole, ritonavir, boceprevir, telaprevir, troleandomycin, clarithromycin, carbamazepine, enzalutamide, mitotane, phenytoin,
    phenobarbital, fluconazole, isoniazid, metronidazole, paroxetine, sulfamethoxazole, rifampicin, St. John’s Wort, diltiazem, idelalisib, nefazodone and nelfinavir.
    7. Clinically significant abnormal electrocardiogram (ECG) at Visit 1 and pre-dose at Visit 2. This includes, but is not limited to, a QTcF > 470 msec (for women) or > 450 msec (for men), a PR > 220 msec or ventricular and/or atrial premature contractions that are more frequent than occasional and/or occur as couplets or
    higher in grouping.
    8. Any clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality.
    9. Any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disease or disorder which, in the opinion of the Investigator, would jeopardize the safety of the subject by taking part in the trial.
    10. History of substance abuse or dependence that would interefere with the completion of the study, as determined by the Investigator.
    11. Known lactose allergy or intolerance.
    12. Known hypersensitivity to KVD900 or placebo or to any of the excipients.
    13. Participation in an interventional investigational clinical study within 93 days or within 5 half-lives of the last dosing of investigational drug (whichever is longer) prior to initial study treatment.
    14. Any pregnant or breast-feeding subject.
    1. Qualunque diagnosi concomitante di un’altra forma di angioedema cronico, come deficienza acquisita dell’inibitore C1, HAE con c1-INH normale (conosciuta anche come HAE di tipo III), angioedema idiopatico o angioedema associato con orticaria.
    2. Uso corrente di C1INH, androgeni, lanadelumab o acido tranexamico per la profilassi HAE.
    3. Uso di inibitori dell’enzima convertitore
    dell'angiotensina (ACE) e di farmaci contenenti estrogeni con assorbimento sistemico (come contraccettivi orali o terapia di sostituzione ormonale) nei 93 giorni precedenti al trattamento iniziale dello studio.
    4. Uso di androgeni (per es. stanozololo, danazolo, oxandrolone, metiltestosteroni, testosterone) o antifibrinolitici nei 30 giorni precedenti al trattamento iniziale dello studio.
    5. Uso di lanadelumab nelle 10 settimane precedenti al trattamento iniziale dello studio
    6. Uso di potenti inibitori e induttori del CYP3A4 / CYP2C9 durante la partecipazione allo studio.
    Nota: questi farmaci comprendono ma non sono limitati a quanto segue: cobicistat, conivaptan, itraconazolo, ketoconazolo, posaconazolo, voriconazolo, ritonavir, boceprevir, telaprevir, troleandomicina, claritromicina, carbamazepina, enzalutamide, mitotano, fenitoina, fenobarbital, fluconazolo, isoniazide, metronidazolo , paroxetina, sulfametossazolo, rifampicina, erba di San Giovanni, diltiazem, idelalisib, nefazodone e nelfinavir.
    7. Elettrocardiogramma anormale clinicamente significativo (ECG) alla Visita 1 e pre-dose alla Visita 2. Ciò include, ma non è limitato a, un QTcF> 470 msec (per le donne) o> 450 msec (per gli uomini), una PR> 220 msec o contrazioni premature ventricolari e / o atriali che sono più frequenti di occasionali e / o si verificano come distici o superiori nel raggruppamento..
    8. Qualsiasi storia clinicamente significativa di angina, infarto miocardico, sincope, aritmie cardiache clinicamente significative, ipertrofia ventricolare sinistra, cardiomiopatia o qualsiasi altra anomalia cardiovascolare
    9. Qualsiasi altra disfunzione sistemica (ad esempio, gastrointestinale, renale, respiratoria, cardiovascolare) o malattia o disturbo significativo che, secondo il parere dello sperimentatore, metterebbe a repentaglio la sicurezza del soggetto partecipando allo studio
    10. Storia di abuso di sostanze o dipendenza che interferirebbe con il completamento dello studio, in base a quanto rilevato dallo Sperimentatore.
    11. Nota allergia o intolleranza al lattosio.
    12. Ipersensibilità nota a KVD900 o placebo o ad uno qualsiasi degli eccipienti
    13. Partecipazione a uno studio clinico interventistico nei 93 giorni o entro 5 emivite dell’ultima dose del farmaco sperimentale (qualunque dei due periodi sia il più prolungato) prima del trattamento iniziale dello studio.
    14. Soggetti in gravidanza o che allattino al seno.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints:
    • Time to use of conventional attack treatment.
    Endpoint di efficacia primari:
    • Momento di utilizzo del trattamento tradizionale per gli attacchi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 hours
    12 ore
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • Proportion of HAE attacks that progress by one level or more on the
    5LS or that require conventional attack treatment within 12h of study
    drug.
    • Time between treatment and (1) progression of global attack severity
    on the 5LS by one level or more, or (2) use of conventional attack
    treatment, whichever comes first within 12h
    Endpoint di efficacia secondari:
    • Proporzione degli attacchi di HAE che avanza di uno o più livelli nella 5LS o che richiede il trattamento tradizionale per gli attacchi entro 12 ore di farmaco dello studio.
    • Tempo fra il trattamento e (1) avanzamento di uno o più livelli nella 5LS, oppure (2) utilizzo del trattamento tradizionale per gli attacchi, quello dei due eventi che si verifica per primo entro 12 ore.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 hours
    12 ore
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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.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 Yes
    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 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 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 States
    Austria
    Czechia
    France
    Germany
    Hungary
    Netherlands
    Poland
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 55
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 60
    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)
    nessuno
    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 Decision2019-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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