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    Summary
    EudraCT Number:2019-002785-12
    Sponsor's Protocol Code Number:CY6021
    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:2021-02-04
    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 number2019-002785-12
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, volto alla definizione del dosaggio, per valutare la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica di CK-3773274 in soggetti adulti con cardiomiopatia ipertrofica sintomatica e ostruzione del tratto di efflusso ventricolare sinistro
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetic and Pharmacodynamic study to evaluate the effect of CK3773274 in patients with obstructive hypertrophic cardiomyopathy (oHCM)
    Studio farmacocinetico e farmacodinamico volto a valutare l'effetto di CK3773274 in pazienti con cardiomiopatia ipertrofica ostruttiva (oHCM)
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberCY6021
    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 SponsorCYTOKINETICS, INC.
    B.1.3.4CountryUnited States
    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 supportCytokinetics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytokinetics Inc
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street Address280 East Grand Avenue
    B.5.3.2Town/ citySouth San Francisco CA
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number16506242929
    B.5.6E-mailmedicalaffairs@cytokinetics.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 namen/a
    D.3.2Product code [CK-3773274]
    D.3.4Pharmaceutical form Film-coated 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 INNCK-3773274
    D.3.9.2Current sponsor codeCK-3773274
    D.3.9.3Other descriptive name(R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
    D.3.9.4EV Substance CodeSUB197451
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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.IMP: 2
    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 namen/a
    D.3.2Product code [CK-3773274]
    D.3.4Pharmaceutical form Film-coated 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 INNCK-3773274
    D.3.9.2Current sponsor codeCK-3773274
    D.3.9.3Other descriptive name(R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
    D.3.9.4EV Substance CodeSUB197451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    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 namen/a
    D.3.2Product code [CK-3773274]
    D.3.4Pharmaceutical form Film-coated 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 INNCK-3773274
    D.3.9.2Current sponsor codeCK-3773274
    D.3.9.3Other descriptive name(R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
    D.3.9.4EV Substance CodeSUB197451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 4
    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 namen/a
    D.3.2Product code [CK-3773274]
    D.3.4Pharmaceutical form Film-coated 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 INNCK-3773274
    D.3.9.2Current sponsor codeCK-3773274
    D.3.9.3Other descriptive name(R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
    D.3.9.4EV Substance CodeSUB197451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Obstructive hypertrophic cardiomyopathy (oHCM)
    Cardiomiopatia ipertrofica ostruttiva (oHCM)
    E.1.1.1Medical condition in easily understood language
    Heart disease with thickening of the heart muscle
    Malattia cardiaca con ispessimento del muscolo cardiaco
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020871
    E.1.2Term Hypertrophic cardiomyopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of CK­3773274 in patients with symptomatic oHCM
    Determinare la sicurezza e la tollerabilità di CK3773274 in pazienti con oHCM sintomatica
    E.2.2Secondary objectives of the trial
    To describe the concentration-response relationship of CK­3773274 on the resting and post-Valsalva LVOT-G on echocardiogram over 10 weeks of treatment.
    To describe the dose response relationship of CK­3773274 in patients with symptomatic oHCM.
    To evaluate the plasma concentrations of CK­3773274 in patients with oHCM.
    Descrivere la relazione concentrazione-risposta di CK3773274 all’elettrocardiogramma di LVOT-G a riposo e post-Valsalva nelle 10 settimane di trattamento.
    Descrivere la relazione dose-risposta di CK3773274 in pazienti con oHCM sintomatica.
    Valutare le concentrazioni plasmatiche di CK3773274 in pazienti con oHCM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Able to comprehend and willing to sign an ICF and willing to comply with all study procedures and restrictions for the duration specified in the Schedule of Activities (SoA). Males and females between 18 and 70 years of age at Screening.
    Body weight is =45 kg at Screening. Diagnosed with oHCM per the following criteria:
    • Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease.
    • Has minimal wall thickness =15 mm at time of initial diagnosis (minimal wall thickness =13 mm is acceptable with a positive family history of HCM or with a known disease-causing gene mutation).
    Adequate acoustic windows for echocardiography.
    Has LVOT-G during screening as follows:
    • Resting gradient =50 mmHg
    OR
    • Resting gradient =30 mmHg and <50 mmHg with post-Valsalva LVOT G =50 mmHg
    LVEF =60% at screening.
    New York Heart Association (NYHA) Class II or III at Screening.
    Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for >4 weeks prior to Randomization and anticipate remaining on the same medication regimen during the study.
    In grado di comprendere e acconsente a firmare l’ICF e acconsente a aderire a tutte le procedure e le restrizioni dello studio per la durata specificata nel Programma delle attività (SoA).
    Pazienti di sesso maschile o femminile di età compresa tra 18 e 70 anni allo Screening.
    Peso corporeo =45 kg allo screening.
    Con diagnosi di oHCM in base ai seguenti criteri:
    • Con ipertrofia LV e camera LV non dilatata in assenza di altra malattia cardiaca.
    • Con spessore minimo della parete =15 mm al momento della diagnosi iniziale (uno spessore minimo della parete =13 mm è accettabile con una anamnesi familiare positiva di HCM o con una mutazione genica causativa nota).
    Finestre acustiche adeguate per l’ecocardiografia.
    Con LVOT-G durante lo screening come segue:
    • Gradiente a riposo =50 mmHg
    OPPURE
    • Gradiente a riposo =30 mmHg e <50 mmHg con LVOT-G post-Valsalva =50 mmHg
    LVEF =60% allo screening.
    Classe II o III della New York Heart Association (NYHA) allo screening.
    Pazienti che assumono beta-bloccanti, verapamil, diltiazem o ranolazina devono essere stati a dosi stabili per > 4 settimane prima della Randomizzazione e prevedere di rimanere allo stesso regime di trattamento durante lo studio.
    E.4Principal exclusion criteria
    Aortic stenosis or fixed subaortic obstruction.
    Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
    History of LV systolic dysfunction (LVEF <45%) at any time during their clinical course.
    Documented history of current obstructive coronary artery disease (>70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
    Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment
    during the study period. Has been treated with disopyramide or antiarrhythmic drugs that have negative inotropic activity within 4 weeks prior to screening.
    Documented atrial fibrillation during the Screening period.
    Paroxysmal atrial fibrillation or flutter requiring treatment (eg, anticoagulation or antiarrhythmic therapy including disopyramide) documented within the 6 months prior to Screening.
    History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening.
    Has received prior treatment with CK­3773274 or is currently receiving mavacamten.
    Stenosi aortica o ostruzione subaortica fissa.
    Malattia infiltrativa o da accumulo nota che provoca ipertrofia cardiaca che mimica oHCM (ad es. sindrome di Noonan, malattia di Fabry, amiloidosi).
    Anamnesi di disfunzione sistolica LV (LVEF <45%) in qualsiasi momento durante il decorso clinico.
    Anamnesi documentata di attuale coronaropatia ostruttiva (>70% stenosi in una o più arterie coronarie epicardiche) o anamnesi documentata di infarto del miocardio.
    Ha ricevuto un trattamento con terapia di riduzione del setto (miectomia chirurgica o ablazione percutanea alcolica del setto) o prevede di sottoporsi a uno dei due trattamenti durante lo studio.
    È stato/a trattato/a con disopiramide o farmaci antiaritmici che hanno una attività inotropica negativa entro 4 settimane prima dello screening.
    Fibrillazione atriale documentata durante il periodo di screening.
    Fibrillazione atriale parossistica o flutter che necessita di trattamento (ad es. terapia con anticoagulante o antiaritmica compreso disopiramide) documentata entro 6 mesi prima dello screening.
    Anamnesi di sincope o tachiaritmia ventricolare sotto sforzo sostenuta entro 6 mesi prima dello screening.
    Ha ricevuto un precedente trattamento con CK3773274 o sta attualmente ricevendo mavacamten.
    E.5 End points
    E.5.1Primary end point(s)
    • Patient incidence of reported AEs
    • Patient incidence of reported SAEs
    • Patient incidence of LVEF < 50%
    • Incidenza degli AE segnalati nei pazienti
    • Incidenza degli SAE segnalati nei pazienti
    • Incidenza di LVEF < 50% nei pazienti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14
    Settimana 14
    E.5.2Secondary end point(s)
    • The slope of the relationship of the plasma concentration of CK­3773274 to the change from baseline in the resting LVOT-G
    • The slope of the relationship of the plasma concentration of CK­3773274 to the change from baseline in the post-Valsalva LVOT-G
    • The change from baseline in resting and post-Valsalva LVOT-G over time as a function of dose
    • The change from baseline in resting and post-Valsalva LVOT-G to Week 10
    • Observed maximum plasma concentration (Cmax) and trough plasma concentration (Ctrough) for CK-3773274
    • Curva del rapporto della concentrazione plasmatica di CK3773274 rispetto al cambiamento dal basale nel LVOT-G a riposo
    • Curva del rapporto della concentrazione plasmatica di CK3773274 rispetto al cambiamento dal basale nel LVOT-G post-Valsalva
    • Cambiamento dal basale nel LVOT-G a riposo e post-Valsalva nel tempo in funzione della dose
    • Cambiamento dal basale nel LVOT-G a riposo e post-Valsalva fino alla Settimana 10
    • Concentrazione plasmatica massima (Cmax) e concentrazione plasmatica minima (Ctrough) osservate per CK-3773274
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 10
    Settimana 10
    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 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 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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Italy
    Netherlands
    Spain
    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
    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 months1
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days24
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 28
    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)
    Subjects who complete the Week 14 visit in CY 6021 will be offered the opportunity to participate in an open-label extension study.
    Ai soggetti che completano la visita della Settimana 14 nello studio CY 6021 sarà offerta l’opportunità di partecipare ad uno studio di estensione in aperto.
    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 Decision2020-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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