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    Summary
    EudraCT Number:2018-004774-97
    Sponsor's Protocol Code Number:C-935788-057
    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:2021-01-22
    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 number2018-004774-97
    A.3Full title of the trial
    A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
    Studio di Fase 3, Multicentrico, Randomizzato, Doppio-Cieco, Controllato con Placebo nel Trattamento dell’Anemia Emolitica Autoimmune da Anticorpi Caldi con Fostamatinib Disodico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen.
    Questo è uno studio di Fase 3 multicentrico, randomizzato, doppio cieco, controllato con placebo, in gruppi paralleli per investigare sull'efficacia del trattamento in 24 settimane con fostamatinib (R788) vs. placebo per l'aumento dell'emoglobina in soggetti con anemia emolitica autoimmune da anticorpi caldi (wAIHA) che hanno fallito almeno un regime di trattamento precedente.
    A.3.2Name or abbreviated title of the trial where available
    C-935788-057
    C-935788-057
    A.4.1Sponsor's protocol code numberC-935788-057
    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 SponsorRIGEL PHARMACEUTICALS, 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 supportRigel Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Rigel Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointSandra Tong
    B.5.3 Address:
    B.5.3.1Street Address1180 Veterans Boulevard
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016506241207
    B.5.5Fax number0016503996357
    B.5.6E-mailstong@rigel.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 nameFostamatinib Disodium
    D.3.2Product code [R935788]
    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 INNFostamatinib
    D.3.9.1CAS number 914295-16-2
    D.3.9.2Current sponsor codeFostamatinib Disodium R935788
    D.3.9.4EV Substance CodeSUB32625
    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.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 nameFostamatinib Disodium
    D.3.2Product code [R935788]
    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 INNFostamatinib
    D.3.9.1CAS number 914295-16-2
    D.3.9.2Current sponsor codeFostamatinib Disodium R935788
    D.3.9.4EV Substance CodeSUB32625
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Warm antibody autoimmune hemolytic anemia (wAIHA)
    Anemia Emolitica Autoimmune da Anticorpi Caldi (wAIHA)
    E.1.1.1Medical condition in easily understood language
    Autoimmune hemolytic anemia (AIHA) is an acquired disorder manifested by autoantibody- mediated red blood cell (RBC) destruction.
    Anemia Emolitica Autoimmune (AIHA) è un disturbo acquisito che si manifesta con distruzione dei globuli rossi (RBC) autoanticorpati.
    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 10003825
    E.1.2Term Autoimmune hemolytic anemia
    E.1.2System Organ Class 100000004851
    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 assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
    L'obiettivo principale di questo studio è valutare l'efficacia di fostamatinib in soggetti con Anemia Emolitica Autoimmune da Anticorpi Caldi (wAIHA).
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess the safety of fostamatinib in subjects with wAIHA.
    L'obiettivo secondario di questo studio è di valutare la sicurezza di fostamatinib in soggetti con wAIHA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
    2. Subject must have a diagnosis of primary or secondary wAIHA as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA. Eligibility may be based on a historical DAT obtained within 12 months of the screening visit from a local laboratory, provided that specific IgG positivity is documented; otherwise, this assay will be done at screening by a central laboratory.
    3. Has failed or not tolerated at least one prior wAIHA treatment, e.g., steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil (MMF), danazol, vincristine, ESA or splenectomy (folate, iron or other supplements do not fulfill this criterion).
    4. Has haptoglobin <LLN or total bilirubin >ULN or lactate dehydrogenase (LDH) >ULN.
    5. At screening, subject’s hemoglobin level must be =9 g/dL
    OR
    If the hemoglobin value is >9 g/dL and <10 g/dL, subject must be on an allowed wAIHA treatment (see Allowed AIHA Therapy table) AND the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain).
    6. Male or female at least 18 years of age at screening.
    7. Karnofsky performance status (KPS) =70.
    8. Subject’s concurrent treatment for wAIHA may consist of no more than two of any of the following agents: azathioprine, steroids, ESAs, mycophenolate mofetil, dapsone or danazol at a stable dose, as defined in the Allowed AIHA Therapies table.
    9. Female subjects must be either post-menopausal for at least 1 year or surgically sterile; or, if of childbearing potential, must not be pregnant or lactating and must agree to use a highly effective method of birth control throughout the duration of the trial and for 30 days following the last dose. Acceptable methods of birth control are defined as: hormonal contraception (pill, injection or implant) used consistently for at least 30 days prior to screening, an intrauterine device (IUD), or intrauterine hormone-releasing system (IUS), or true abstinence (i.e. abstinence is in line with the preferred and usual lifestyle of the subjects).
    10. In the investigator’s opinion, the subject has the ability to understand the nature of the study and any hazards of participation and to communicate satisfactorily with the investigator.
    1. Il soggetto deve essere disposto e in grado di fornire il consenso informato scritto firmando un Modulo di consenso informato approvato dall'IRB prima di sottoporsi a qualsiasi procedura specifica dello studio.
    2. Il soggetto deve presentare diagnosi di wAIHA primaria o secondaria come documentato da un test dell'antiglobulina diretto (DAT) positivo specifico per anti-IgG o anti-IgA. L'eleggibilità può essere basata su un precedente test DAT eseguito nei 12 mesi precedenti la visita di screening da un laboratorio locale, a condizione che sia documentata la positività specifica delle IgG; in caso contrario, tale analisi sarà effettuata allo screening da un laboratorio centrale.
    3. Presentare insuccesso o mancata tolleranza di almeno un precedente trattamento per la wAIHA, ad esempio steroidi, rituximab, azatioprina, ciclofosfamide, ciclosporina, micofenolato mofetile (MMF), danazolo, vincristina, ESA o splenectomia (folati, ferro o altri integratori non soddisfano questo criterio).
    4. Presentare valori di aptoglobina < LLN o bilirubina totale > ULN o lattato deidrogenasi (LDH) > ULN.
    5. Allo screening, il livello di emoglobina del soggetto deve essere = 9 g/dL
    OPPURE
    Se il valore dell'emoglobina è > 9 g/dL e < 10 g/dL, il soggetto deve essere sottoposto a un trattamento per la wAIHA consentito (vedere la tabella delle Terapie consentite per l'AIHA) E il soggetto deve presentare sintomi documentati correlati all'anemia (ad es. debolezza, vertigini, affaticamento, respiro corto, dolore toracico).
    6. Soggetti di sesso maschile o femminile di almeno 18 anni d'età allo screening.
    7. Stato di performance Karnofsky (KPS) =70.
    8. Il trattamento concomitante del soggetto per la wAIHA può essere costituito da non più di due dei seguenti agenti: azatioprina, steroidi, ESA, micofenolato mofetile, dapsone o danazolo a una dose stabile, come definito nella tabella delle Terapie consentite per l'AIHA.
    9. I soggetti di sesso femminile devono essere in stato di post-menopausa da almeno 1 anno o chirurgicamente sterili; oppure, se potenzialmente fertili, non devono essere in gravidanza o in allattamento e devono accettare di usare un metodo contraccettivo altamente efficace per tutta la durata della sperimentazione e per i 30 giorni successivi all'ultima dose. I metodi contraccettivi accettabili sono definiti come: contraccettivo ormonale (pillola, iniezione o impianto) usato in modo costante da almeno 30 giorni prima dello screening, dispositivo intrauterino (IUD) o sistema intrauterino a rilascio di ormoni (IUS) o reale astinenza (es. l'astinenza è in linea con lo stile di vita preferito e abituale dei soggetti).
    10. Secondo il parere dello sperimentatore, il soggetto ha la capacità di comprendere la natura dello studio e tutti i rischi della partecipazione e di comunicare in modo soddisfacente con lo sperimentatore.
    E.4Principal exclusion criteria
    1. Subject with other types of AIHA (e.g., cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria).
    2. Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosus (SLE), or lymphoid malignancy if the underlying disease is not stable or is not well-controlled on current therapy, per investigator medical judgment.
    3. Subject has a history of or active, clinically significant, cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the investigator’s opinion, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug.
    4. Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure =135 mmHg or diastolic blood pressure =85 mmHg, whether or not the subject is receiving anti-hypertensive treatment.
    5. Subject has one or more of the following laboratory abnormalities at screening: neutrophil count of <1,000/µL or platelet count of <30,000/µL, unless due to Evans syndrome; transaminase levels (i.e., alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) >1.5 x ULN.
    6. Has documented active hepatitis B or hepatitis C infection or HIV infection.
    7. Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of Day 1.
    8. In the judgment of the investigator, the subject may not be able to fully comply with study requirements.
    9. Subject has been treated with fostamatinib previously for any indication.
    10. Subject has a known allergy and/or sensitivity to the test article or its components.
    11. Subject has had a splenectomy within the past 4 weeks.
    1. Soggetto con altri tipi di AIHA (ad es., AIHA da anticorpi freddi, sindrome da agglutinine a frigore, AIHA di tipo misto o emoglobinuria parossistica a frigore).
    2. Il soggetto presenta AIHA secondaria a malattia autoimmune, incluso lupus eritematoso sistemico (LES) o neoplasia linfoide se la malattia preesistente non è stabile o non è ben controllata con la terapia attuale, secondo il giudizio medico dello sperimentatore.
    3. Il soggetto ha un disturbo clinicamente significativo in anamnesi o in atto di natura cardiovascolare, respiratoria, gastrointestinale, renale, epatica, neurologica, psichiatrica, muscoloscheletrica, genitourinaria, dermatologica o di altra natura che, secondo il parere dello sperimentatore, potrebbe influenzare la conduzione dello studio o l'assorbimento, il metabolismo o l'escrezione del farmaco in studio.
    4. Il soggetto presenta ipertensione non controllata o scarsamente controllata, definita come pressione arteriosa sistolica = 135 mmHg o pressione arteriosa diastolica = 85 mmHg, indipendentemente dal fatto che il soggetto stia ricevendo o meno un trattamento antipertensivo.
    5. Il soggetto presenta una o più delle seguenti anomalie di laboratorio allo screening: conta dei neutrofili < 1.000/µl o conta piastrinica < 30.000/µl, salvo se dovuta a sindrome di Evans; livelli di transaminasi (ossia, alanina aminotransferasi [ALT] o aspartato aminotransferasi [AST]) > 1,5 x ULN.
    6. Presentare infezione attiva da epatite B o C documentata o infezione da HIV.
    7. Il soggetto è attualmente arruolato in uno studio su un farmaco o dispositivo sperimentale o ha usato un farmaco o dispositivo sperimentale nei 30 giorni o nelle 5 emivite (a seconda del periodo più lungo) precedenti il Giorno 1.
    8. Secondo il giudizio dello sperimentatore, il soggetto potrebbe non essere in grado di soddisfare pienamente i requisiti dello studio.
    9. Il soggetto è stato precedentemente trattato con fostamatinib per qualsiasi indicazione.
    10. Il soggetto presenta una allergia e/o sensibilità nota al prodotto sperimentale o ai suoi componenti.
    11. Il soggetto è stato sottoposto a splenectomia nelle 4 settimane precedenti.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects who achieve a durable response.
    A hemoglobin response is defined as a hemoglobin level of >10 g/dL and =2 g/dL higher than the baseline (Day 1) value if, during the previous 4 weeks, the steroid dose was maintained at the baseline level and rescue medication was not administered.
    A durable response is defined as a hemoglobin response on at least 3 scheduled visits during the 24-week evaluation period.
    L'endpoint di efficacia primario è la percentuale di soggetti che raggiungono una risposta duratura.
    Una risposta dell'emoglobina è definita come un livello di emoglobina di >10 g/dL e = 2 g/dL più elevato rispetto al valore basale (Giorno 1) se, durante le 4 settimane precedenti, la dose di steroidi è stata mantenuta al livello basale e non sono stati somministrati farmaci di salvataggio.
    Una risposta duratura è definita come una risposta dell'emoglobina in almeno 3 visite programmate durante il periodo di valutazione di 24 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 week evaluation
    valutazione di 24 settimane
    E.5.2Secondary end point(s)
    • Proportion of subjects with a hemoglobin response by Week 24
    • Proportion of subjects requiring wAIHA rescue therapy
    • Average number of weeks with hemoglobin response
    Safety Endpoints:-Incidence of adverse events;-Incidence of abnormal changes from baseline in laboratory values per CTCAE criteria v5.0 (e.g.hematology,chemistry)
    Exploratory endpoints:
    • Change from baseline in EQ-5D and FACIT-F domains at Week 24
    • Median hemoglobin at Week 24
    • Median change from baseline in hemoglobin at Week 24
    • Median duration of the first hemoglobin response
    • Proportion of subjects who had =25% reduction from baseline in the
    total daily dose of steroids
    • Median cumulative dose of steroids (prednisone equivalent)
    Pharmacokinetic Endpoints:
    Plasma concentration of the active component of fostamatinib, (R406),
    at Weeks 2, 4, 12 and 18 of the treatment period.
    • Percentuale di soggetti con una risposta dell'emoglobina entro la Settimana 24
    • Percentuale di soggetti che richiedono terapia di salvataggio per la wAIHA
    • Numero medio di settimane con risposta dell'emoglobina
    Endpoints di sicurezza:-Incidenza degli eventi avversi;-Incidenza di cambiamenti anormali nel valori di laboratorio dal baseline per il criterio CTCAE v5.0 (es ematologia, chimica);-Incidenza dei cambiamenti nella pressione sanguigna confrontata al baseline
    Endpoint esplorativi:-Cambiamento dal baseline nei domini EQ-5D e FACIT-F alla settimana 24;-Emoglobina mediana alla settimana 24;-Variazione mediana rispetto al baseline dell'emoglobina alla settimana 24;-Durata mediana della prima risposta di emoglobina;-Proporzione di soggetti che hanno avuto una riduzione = 25% rispetto al basale nella dose giornaliera totale di steroidi;-Dose cumulativa mediana di steroidi (equivalente al prednisone)
    Endpoint farmacocinetici:-Concentrazione plasmatica del componente attivo di fostamatinib, (R406),
    alle settimane 2, 4, 12 e 18 del periodo di trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 week evaluation
    valutazione di 24 settimane
    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 No
    E.6.7Pharmacodynamic No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belarus
    Belgium
    Bulgaria
    Canada
    Czechia
    Denmark
    France
    Georgia
    Germany
    Hungary
    Italy
    Netherlands
    Norway
    Romania
    Russian Federation
    Serbia
    Spain
    Ukraine
    United Kingdom
    United States
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 81
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 81
    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)
    Extended treatment will be available to eligible subjects under a separate a protocol. All other subjects will return to standard treatment.
    Il trattamento esteso sarà disponibile per i soggetti idonei con un protocollo separato. Tutti gli altri soggetti torneranno al trattamento standard.
    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 Decision2019-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-16
    P. End of Trial
    P.End of Trial StatusOngoing
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