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    Summary
    EudraCT Number:2018-002146-37
    Sponsor's Protocol Code Number:INCB50465-208
    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:2020-11-04
    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 number2018-002146-37
    A.3Full title of the trial
    A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris
    Studio di fase 2 di incremento progressivo della dose sulla sicurezza e la tollerabilità di INCB050465 nei partecipanti affetti da pemfigo volgare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test if increasing doses of the drug INCB050465 is safe and well tolerated in patients with Pemphigus Vulgaris
    Uno studio per verificare se le dosi crescenti del farmaco INCB050465 sono sicure e ben tollerate in pazienti con Pemfigo Vulgaris
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberINCB50465-208
    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 SponsorINCYTE CORPORATION
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number0000000
    B.5.5Fax number0013024252734
    B.5.6E-mailRA@incyte.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.2.1.1.1Trade name NA
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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 nameINCB050465 1.0 mg
    D.3.2Product code [NA]
    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 INNINCB050465
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB183790
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 nameINCB050465 0.3 mg
    D.3.2Product code [NA]
    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 INNINCB050465
    D.3.9.2Current sponsor codeINCB050465
    D.3.9.4EV Substance CodeSUB183790
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 nameINCB050465 2.5mg
    D.3.2Product code [NA]
    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 INNINCB050465 HYDROCHLORIDE
    D.3.9.2Current sponsor codeINCB050465
    D.3.9.4EV Substance CodeSUB183790
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pemphigus vulgaris
    Pemfigo Volgare
    E.1.1.1Medical condition in easily understood language
    Pemphigus vulgaris
    Pemfigo Volgare
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052802
    E.1.2Term Pemphigus vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of INCB050465 in participants with pemphigus vulgaris
    Valutare la sicurezza e la tollerabilità di INCB050465 nei partecipanti affetti da pemfigo volgare
    E.2.2Secondary objectives of the trial
    To determine the systemic exposure to INCB050465
    Determinare l’esposizione sistemica a INCB050465.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged 18 to 80 years at the time of consent.

    2. Clinically documented and confirmed diagnosis of pemphigus vulgaris:
    a. Minimum of 6 months of pemphigus vulgaris diagnosis
    b. Positive for anti-DSG1 or DSG-3
    c. PDAI score of 8 to 45 points
    d. Have active skin, scalp, or mucosal lesions

    3. Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment. There is no limit to the number of prior treatment regimens.

    4. Willingness to avoid pregnancy or fathering children based on the criteria below.
    a. Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed.
    b. Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
    c. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal, defined as = 12 months of amenorrhea before screening, confirmed by FSH levels at screening) are eligible.

    5. If required, willing to receive PJP prophylaxis during the study period.
    1. Uomini e donne di età compresa tra 18 e 80 anni al momento del consenso.

    2. Diagnosi di pemfigo volgare clinicamente documentata e confermata:
    a. Minimo 6 mesi dalla diagnosi di pemfigo volgare
    b. Esito positivo per anti-DSG1 o DSG-3
    c. Punteggio PDAI da 8 a 45 punti
    d. Presentano lesioni attive cutanee, del cuoio capelluto o mucosali

    3. Partecipanti che presentano una progressione della malattia dopo il trattamento con terapie standard note per apportare un beneficio clinico o che sono intolleranti al trattamento. Non esiste un limite al numero di precedenti regimi di trattamento.

    4. La disponibilità a evitare la gravidanza o a procreare sulla base dei seguenti criteri.
    a. Gli uomini devono accettare di adottare precauzioni atte a evitare di procreare (con una certezza di almeno il 99%) dallo screening fino a 90 giorni dopo l'ultima dose del farmaco dello studio e devono evitare di donare sperma durante questo periodo. I metodi consentiti che hanno un’efficacia anticoncezionale almeno del 99% (vedere l'appendice A) devono essere comunicati ai partecipanti che devono confermare di averli compresi.
    b. Le donne in grado di procreare devono sottoporsi a un test di gravidanza sierologico con esito negativo allo screening e prima della prima dose al Giorno 1 e devono accettare di adottare precauzioni atte a evitare una gravidanza (con una certezza di almeno il 99%) dallo screening al follow-up per la sicurezza. I metodi consentiti che hanno un’efficacia anticoncezionale almeno del 99% devono essere comunicati ai partecipanti che devono confermare di averli compresi.
    c. Le donne fisiologicamente incapaci di restare incinte (ossia chirurgicamente sterili in seguito a isterectomia e/o ovariectomia bilaterale OPPURE in post-menopausa definita come = 12 mesi di amenorrea prima dello screening, confermata dai livelli di FSH allo screening) sono idonee.

    5. Se richiesto, disponibilità a ricevere profilassi per la PJP durante il periodo dello studio
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding female.
    2. Participants with pemphigus vulgaris who are treatment-naive.
    3. Use of the following medications within the following periods before baseline:
    a. 2 weeks:
    i. Potent systemic CYP3A4 inhibitors and inducers or fluconazole.
    ii. Topical treatment of pemphigus vulgaris lesions that may affect the disease assessment activities (eg, corticosteroids or tacrolimus/pimecrolimus).
    b. 4 weeks: Systemic immunosuppressive (eg, cyclophosphamide and methotrexate), etanercept, anakinra, prednisone > 0.5 mg/kg per day (or oral corticosteroid equivalent dose).
    c. 12 weeks or 5 half-lives (whichever is longer): infliximab, adalimumab, golimumab, abatacept, tocilizumab, certolizumab, secukinumab, IVIG, plasmapheresis, or any other biologic or experimental treatment.
    d. 12 months: Anti-CD20 monoclonal antibody, for example, rituximab and ofatumumab.
    4. Evidence or history of clinically significant infection or medical condition including the following:
    a. Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of pemphigus vulgaris.
    b. Chronic or ongoing infectious disease requiring long-term systemic treatment, including but not limited to chronic renal infection or chronic pulmonary infection with bronchiectasis.
    c. Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study.
    d. Positive test result for TB from the QuantiFERON®-TB Gold test or T-SPOT.TB test at screening (or, if 2 indeterminate tests, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening).
    e. A history of active TB (treated or untreated) or history of untreated latent TB.
    f. Positive serology test results for HIV, HBsAg, HBV core antibody, or HCV (HCV antibody with positive HCV-RNA) at screening.
    g. Received live vaccine within 4 weeks before baseline or planning to receive live vaccine during the course of the study or within 4 weeks after EOT.
    h. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as > 470 milliseconds for male and > 480 milliseconds for females.
    i. History of malignancy within 5 years before baseline, other than a successfully treated nonmetastatic neoplasms (eg, cutaneous squamous cell carcinoma, basal cell carcinoma, localized carcinoma in situ of the cervix, or melanoma in situ)
    j. History of solid organ transplant.
    k. Any serious illness or medical, physical, or psychiatric condition(s) that, in the opinion of the investigator, would pose a significant risk to the participant or interfere with the interpretation of safety, efficacy, or pharmacodynamic data.
    5. Participants with laboratory values at screening, according to the Protocol
    6. Known or suspected allergy to INCB050465 or any component of the study drug.
    7. Known history of clinically significant drug or alcohol abuse in the last year before baseline.
    8. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
    9. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
    10. Inability of the participant to comprehend or unwilling to sign the ICF.
    1. Donne in gravidanza o allattamento.
    2. Partecipanti affetti da pemfigo volgare naive al trattamento.
    3. Utilizzo dei seguenti farmaci nei seguenti periodi prima del basale:
    a. 2 settimane:
    i. Potenti inibitori e induttori sistemici di CYP3A4 o fluconazolo.
    ii. Il trattamento topico delle lesioni da pemfigo volgare che possono influire sulle attività di valutazione della malattia (ad es., corticosteroidi o tacolimus/pimecrolimus).
    b. 4 settimane: Immunosoppressore sistemico (ad es., ciclofosfamide e metotrexato), etanercept, anakinra, prednisone > 0,5 mg/kg al giorno (o dose equivalente di corticosteroide orale).
    c. 12 settimane o 5 emivite (a seconda di quale durata sia maggiore): infliximab, adalimumab, golimumab, abatacept, tocilizumab, certolizumab, secukinumab, IVIG, plasmaferesi o qualsiasi altro trattamento biologico o sperimentale.
    d. 12 mesi: Anticorpo monoclonale anti-CD20, ad esempio rituximab e ofatumumab.

    4. Evidenza o anamnesi di infezione clinicamente significativa o condizione medica incluso quanto segue:
    a. Qualsiasi altra malattia o condizione cutanea attiva (ad es., infezione batterica, micotica o virale) che possa interferire con il decorso,
    la gravità o le valutazioni del pemfigo volgare.
    b. Malattia infettiva cronica o in corso che richiede un trattamento sistemico a lungo termine incluso, a titolo esemplificativo ma non esaustivo, infezione renale cronica o infezione polmonare cronica con bronchiectasia.
    c. Infezione virale sistemica attiva o qualsiasi infezione virale attiva che, sulla base della valutazione clinica dello sperimentatore, renda il partecipante un candidato inadatto a partecipare allo studio.
    d. Risultato positivo per la TB al test -TB Gold o T-SPOT.TB di QuantiFERON® allo screening (o, in caso di 2 test indeterminati, poi valutati da un test sul derivato proteico purificato, con un risultato di < 5 mm di indurimento entro 3 mesi dallo screening).
    e. Anamnesi di TB attiva (trattata o non trattata) o anamnesi di TB latente non trattata.
    f. Risultati positivi dell’esame sierologico per HIV, HBsAg, anticorpo anti-core HBV o HCV (anticorpo anti HCV con HCV-RNA positivo) allo screening.
    g. Ha ricevuto un vaccino vivo nelle 4 settimane precedenti il basale o pianifica di ricevere un vaccino vivo nel corso dello studio o entro 4 settimane dall'EOT.
    h. Intervallo QT prolungato corretto per frequenza cardiaca utilizzando la formula di Fridericia (QTcF), definito come > 470 millisecondi per gli uomini e > 480 millisecondi per le donne.
    i. Anamnesi di neoplasia maligna nei 5 anni precedenti il basale, ad eccezione di una neoplasia non metastatica trattata con esito positivo (ad es., carcinoma cutaneo a cellule squamose, carcinoma a cellule basali, carcinoma in situ della cervice o melanoma in situ)
    j. Anamnesi di trapianto di organo solido.
    k. Qualsiasi malattia grave o condizione/i di natura medica, fisica o psichiatrica che, secondo l’opinione dello sperimentatore, rappresenterebbe un rischio significativo per il partecipante o interferirebbe con l'interpretazione dei dati di sicurezza, efficacia o farmacodinamica.

    5. Partecipanti con valori di laboratorio allo screening in accordo al protocollo
    6. Allergia nota o sospetta a INCB050465 o a qualsiasi componente del farmaco dello studio.
    7. Precedenti noti di abuso clinicamente significativo di droghe o alcool nell’ultimo anno prima del basale.
    8. Partecipante incapace o restio ad aderire allo schema posologico e alle valutazioni dello studio, secondo l’opinione dello sperimentatore.
    9. Qualsiasi condizione che, secondo il giudizio dello sperimentatore, interferirebbe con la piena partecipazione allo studio, inclusa la somministrazione del farmaco dello studio e la presenza richiesta alle visite dello studio, rappresenterebbe un rischio significativo per il partecipante; o interferirebbe con l’interpretazione dei dati dello studio.
    10. Partecipante incapace di comprendere o che non intende firmare il modulo di consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    • Frequency, duration, and severity of AEs, clinical laboratory test results, vital signs results, ECGs, and physical examination findings.
    • Frequenza, durata e gravità di EA, risultati dei test clinici di laboratorio, risultati dei parametri vitali, ECG ed esiti degli esami obiettivi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Durante lo studio
    E.5.2Secondary end point(s)
    • Assessment of Cmax, tmax, Cmin, AUC0-t, and CL/F.
    • Valutazione di Cmax, tmax, Cmin, AUC0-t e CL/F.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, week 2, week 6
    giorno 1, settimana 2, settimana 6
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    France
    Italy
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 17
    F.4.2.2In the whole clinical trial 18
    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 Decision2019-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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