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    Summary
    EudraCT Number:2019-004765-40
    Sponsor's Protocol Code Number:SPR001-204
    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:2022-09-06
    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 number2019-004765-40
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia
    Studio randomizzato, in doppio cieco, controllato con placebo, volto a valutare l’efficacia e la sicurezza di SPR001 (tildacerfont) nel ridurre l’uso di livelli sovrafisiologici di glucocorticoidi in soggetti adulti affetti da iperplasia surrenale congenita classica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy.
    Questo è uno studio che valuterà lil potenziale di tildacerfont nel ridurre l’uso di glucocorticoidi in soggetti adulti affetti da iperplasia surrenale congenita classica che ricevono una terapia con dose sovrafisiologica di glucocorticoidi
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH
    Efficaia e sicurezza di tildacerfont nel ridurre livelli sovrafisiologici di GC in adulti con ISC
    A.4.1Sponsor's protocol code numberSPR001-204
    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 SponsorSpruce Biosciences 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 supportSpruce Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpruce Biosciences, Inc.
    B.5.2Functional name of contact pointPamela Wedel
    B.5.3 Address:
    B.5.3.1Street Address2001 Junipero Serra Blvd, Suite 640
    B.5.3.2Town/ cityDaly City
    B.5.3.3Post codeCA 94014
    B.5.3.4CountryUnited States
    B.5.4Telephone number+14156554169
    B.5.6E-mailpwedel@sprucebiosciences.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 Yes
    D.2.1.1.1Trade name HYDROCORTISONE - hydrocortisone tablet
    D.2.1.1.2Name of the Marketing Authorisation holderGreenstone LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameHYDROCORTISONE - hydrocortisone tablet
    D.3.2Product code [National drug code: 59762-0074]
    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 INNIDROCORTISONE
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameHYDROCORTISONE
    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: 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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/164/17
    D.3 Description of the IMP
    D.3.1Product nameTildacerfont
    D.3.2Product code [SPR001]
    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 INNTILDACERFONT
    D.3.9.1CAS number 1014983-00-6
    D.3.9.2Current sponsor codeSPR001
    D.3.9.4EV Substance CodeSUB192788
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.2.1.1.1Trade name PREDNISOLONE - prednisolone tablet
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePREDNISOLONE - prednisolone tablet
    D.3.2Product code [PREDNISOLONE]
    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 INNPREDNISOLONE
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive namePREDNISOLONE
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Classic Congenital Adrenal Hyperplasia
    Iperplasia Surrenalica Congenita Classica
    E.1.1.1Medical condition in easily understood language
    CAH is a serious, chronically debilitating, and life-threatening genetic
    disorder characterized by impaired adrenal synthesis of cortisol and
    overproduction of adrenal androgens
    ISC è una grave malattia genetica cronicamente invalidante e potenzialmente letale, con compromissione della sintesi surrenale del cortisolo con conseguente iperproduzione di androgeni surrenalici
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10010323
    E.1.2Term Congenital adrenal hyperplasia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the proportion of subjects who can reduce GC use in subjects with CAH
    Valutare la percentuale di soggetti che possono ridurre l’uso di GC in soggetti con ISC
    E.2.2Secondary objectives of the trial
    -To evaluate the percentage change in GC use in subjects with CAH
    -To evaluate the effect of tildacerfont in reducing the median cumulative HCe dose
    -To evaluate the effect of tildacerfont in reducing cardiovascular risk in subjects with CAH
    -To evaluate the effect of tildacerfont in improving homeostatic model assessment of insulin resistance (HOMA-IR) in subjects with CAH
    -To evaluate the effect of tildacerfont on body weight after 24 weeks in subjects with CAH
    -To evaluate the effect of tildacerfont on body weight after 52 weeks of tildacerfont treatment in subjects with CAH
    - Valutare la variazione percentuale nell’uso di GC in soggetti con ISC
    - Valutare l’effetto di tildacerfont nel ridurre la dose cumulativa mediana di HCe in soggetti con ISC
    - Valutare l’effetto di tildacerfont nel ridurre il rischio cardiovascolare in soggetti con ISC
    - Valutare l’effetto di tildacerfont nel migliorare la valutazione dell’insulino-resistenza mediante modello omeostatico (HOMA-IR) in soggetti con ISC
    - Valutare l’effetto di tildacerfont sul peso corporeo dopo 24 settimane in soggetti con ISC
    - Valutare l’effetto di tildacerfont sul peso corporeo dopo 52 settimane di trattamento con tildacerfont in soggetti con ISC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female subjects = 18 years old at screening
    2.Has a known childhood diagnosis of classic CAH due to 21-hydroxylase deficiency based on genetic mutation in CYP21A2 and/or documented (at any time) elevated 17-OHP and currently treated with HC, HC acetate, prednisone, prednisolone, methylprednisolone (or a combinaton of the aforementionned GCs)
    3.Has LLD = A4 = 2.5x ULN at screening measured before an am GC dose
    4. Has been on a stable, supraphysiologic dose of GC replacement (defined as =30 mg/day and =60 mg/day in HCe) for =1 month before screening
    5.For subjects with the salt-wasting form of CAH, subject has been on a stable dose of mineralocorticoid replacement for =1 month before screening
    6. Follow contraception guidelines . Male subjects must also agree to refrain from donating sperm throughout the Treatment Period and for 90 days after the last dose of study drug.
    7.Is able to understand all study procedures and risks involved and provides written informed consent indicating willingness to comply with all aspects of the protocol.
    1. Soggetti di ambo i sessi di età =18 anni allo screening
    2. Presenta una diagnosi pediatrica nota di ISC classica dovuta a deficit di 21-idrossilasi in base a una mutazione genetica nel CYP21A2 e/o livelli elevati documentati (in qualsiasi momento) di 17-OHP e attualmente trattati con HC, HC acetato, prednisone, prednisolone, metilprednisolone (o una combinazione dei GC summenzionati)
    3. Presenta LLD =A4 =2,5 x ULN allo screening misurata prima della dose mattutina di GC
    4. Ha assunto una dose sovrafisiologica stabile di GC sostitutivo (definita come =30 mg/giorno e =60 mg/giorno in HCe) per =1 mese prima dello screening
    5. Per i soggetti che presentano la forma di ISC con perdita di sali, il soggetto deve aver assunto una dose stabile di mineralcorticoidi sostitutivi per =1 mese prima dello screening
    6. Il soggetto acconsente a seguire le linee guida sulla contraccezione (Sezione 5.2.5). I soggetti di sesso maschile devono inoltre accettare di astenersi dal donare sperma per tutto il periodo di trattamento e per 90 giorni dopo l’ultima dose del farmaco dello studio
    7. Il soggetto è in grado di comprendere tutte le procedure e i rischi dello studio coinvolti e fornisce il consenso informato scritto specificando la propria volontà di attenersi a tutti gli aspetti del protocollo
    E.4Principal exclusion criteria
    1.Has a known or suspected diagnosis of any other known form of classic CAH (not due to 21 hydroxylase deficiency)
    2.Has a history that includes bilateral adrenalectomy or hypopituitarism
    3.Has a history of allergy or hypersensitivity to tildacerfont, any of its excipients, or any other CRF1 receptor antagonist
    4.Shows clinical signs or symptoms of adrenal insufficiency
    5.Has had a clinically significant unstable medical condition, medically significant illness, or chronic disease occurring within 30 days of screening, including but not limited to:
    a.An ongoing malignancy or <3 years of remission history from any malignancy, other than successfully treated localized skin cancer
    b.Estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73 m2
    c. Current or history of liver disease
    d. History of alcohol or substance abuse within the last year
    e. Active hepatitis B, C or HIV at screening
    f. subjects who plan to undergo bariatric surgery during the study are excluded
    g. any other condition that would impact subject safety or confound interpretation
    6.Psychiatric conditions, including but not limited to bipolar disorder, schizophrenia, or schizoaffective disorders that are not effectively controlled on medication and may have an adverse impact on study compliance. Symptoms including hallucinations, delusions, and psychosis are exclusionary. Additionally:
    a. Increased risk of suicide based on the Investigator's judgment or the results of the Columbia–Suicide Severity Rating Scale (C SSRS) conducted at screening and baseline (eg, C-SSRS Type 3, 4, or 5 ideation within the past 6 months or any suicidal behavior within the past 12 months)
    b. HADS score >12 for either depression or anxiety at screening or baseline
    7.Has clinically significant abnormal ECG or clinical laboratory results.
    8. Routinely works overnight shifts
    9.Subjects with travel plans/work schedules that result in significant and frequent changes in time zones (>2 hours) will require Medical Monitor approval for enrollment.
    10.Females who are pregnant or nursing
    11.Use of any other investigational drug from 30 days or 5 half-lives (whichever is longer) before screening to the end of the study
    For the complete list of exclusion criteria please refer to the protocol
    1. Il soggetto presenta una diagnosi nota o sospetta di qualsiasi altra forma nota di ISC classica (non dovuta a deficit di 21-idrossilasi)
    2. Il soggetto presenta un’anamnesi che include surrenectomia bilaterale o ipopituitarismo
    3. Anamnesi di allergia o ipersensibilità a tildacerfont, a qualsiasi dei suoi eccipienti o qualsiasi altro antagonista del recettore di CRF1
    4. Il soggetto mostra segni o sintomi clinici di insufficienza surrenalica
    5. Il soggetto ha manifestato una condizione medica instabile clinicamente significativa, malattia clinicamente significativa o malattia cronica che si è verificata entro 30 giorni dallo screening, incluse, a titolo esemplificativo ma non esaustivo:
    a. una neoplasia maligna in corso o anamnesi di remissione <3 anni da qualsiasi neoplasia maligna diversa da carcinoma cutaneo localizzato trattato con successo;
    b. velocità di filtrazione glomerulare stimata (eGFR) <45 ml/min/1,73 m2;
    c. attuale o anamnesi di malattia epatica (ad eccezione della sindrome di Gilbert);
    d. anamnesi di abuso di alcol o sostanze nell’ultimo anno, o qualsiasi anamnesi significativa di abuso di alcol o sostanze che potrebbe impedire al soggetto di partecipare in modo affidabile allo studio, secondo il parere dello sperimentatore;
    e. infezione attiva da epatite B, epatite C o virus dell’immunodeficienza umana (HIV) allo screening;
    f. sono esclusi i soggetti che prevedono di sottoporsi a un intervento di chirurgia bariatrica durante lo studio;
    g. qualsiasi altra condizione che potrebbe influire sulla sicurezza del soggetto o confondere l’interpretazione dei risultati dello studio.
    6. Condizioni psichiatriche, tra cui, a titolo esemplificativo ma non esaustivo, disturbo bipolare, schizofrenia o disturbi schizoaffettivi che non sono efficacemente controllati con il farmaco e possono avere un impatto avverso sulla conformità allo studio. Sintomi come allucinazioni, deliri e psicosi sono motivo di esclusione. Inoltre:
    a. aumento del rischio di suicidio in base al giudizio dello sperimentatore o ai risultati della Scala della Columbia University per la valutazione della gravità del rischio di suicidio (C-SSRS) condotta allo screening e al basale (ad es. ideazione C-SSRS di tipo 3, 4 o 5 negli ultimi 6 mesi o qualsiasi comportamento suicida negli ultimi 12 mesi);
    b. punteggio sulla Scala della depressione e dell’ansia in ospedale (HADS) >12 per depressione o ansia allo screening o al basale.
    7. Anomalie clinicamente significative nell’elettrocardiogramma (ECG) o nei risultati clinici di laboratorio. I risultati anomali che devono essere esaminati e discussi con il Responsabile del monitoraggio medico per determinare l’idoneità a questo studio includono, a titolo esemplificativo:
    a. qualsiasi risultato ECG anomalo clinicamente significativo, compresi intervalloQT corretto con la formula di Fridericia (QTcF) >450 millisecondi (ms) per i partecipanti di sesso maschile o >470 ms per i partecipanti di sesso femminile;
    b. alanina aminotransferasi (ALT) >2 x ULN;
    c. bilirubina totale >1,5 x ULN;
    d. acidi biliari totali >5 x ULN.
    8. Il soggetto svolge un lavoro regolare che richiede turni notturni
    9. I soggetti con programmi di viaggio/orari lavorativi che comportano cambiamenti di fuso orario significativi e frequenti (>2 ore) dovranno essere autorizzati all’arruolamento dal Responsabile del monitoraggio medico
    10. Donne in stato di gravidanza o in fase di allattamento al seno
    11. Uso di qualsiasi altro farmaco sperimentale a partire da 30 giorni o 5 emivite (a seconda di quale dei due periodi sia più lungo) prima dello screening fino al termine dello studio
    Per una lista completa dei criteri di esclusione fare riferimento al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with at least a 5mg/day HCe reduction from baseline in GC dose and A4 = ULN at Week 24
    Percentuale di soggetti con almeno una riduzione di HCe di 5 mg/die rispetto al basale nella dose di GC e A4 =ULN alla Settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    -Percent change from baseline in GC dose at Week 24
    -Median total cumulative GC dose in HCe at Week 24
    -Proportion of subjects with improvement in at least one cardiovascular risk factor at Week 24
    -Change from baseline in the HOMA-IR at Week 24
    -Percent change from baseline in body weight at Week 24
    -Percent change from baseline in body weight after 52 weeks of tildacerfont treatment
    - Variazione percentuale rispetto al basale nella dose di GC alla Settimana 24
    - Dose cumulativa totale mediana di GC in HCe alla Settimana 24
    - Percentuale di soggetti con miglioramento in almeno un fattore di rischio cardiovascolare alla Settimana 24
    - Variazione rispetto al basale nella valutazione HOMA-IR alla Settimana 24
    - Cambiamento percentuale dal basale nel peso corporeo alla Settimana 24
    - Variazione percentuale rispetto al basale del peso corporeo dopo 52 settimane di trattamento con tildacerfont
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24 and Week 52
    Settimana 24 e Settimana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Marcatori Biologici
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Estensione in aperto opzionale
    Optional open label extension
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Canada
    Korea, Republic of
    United States
    Estonia
    Latvia
    Lithuania
    Poland
    Sweden
    Netherlands
    Romania
    Spain
    Switzerland
    Germany
    Italy
    Denmark
    Ireland
    Turkey
    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
    A subject is considered to have completed study treatment if the subject has completed all visits through Week 76 of the Treatment Period. A subject is considered to have completed the study if the subject has completed all phases of the study, including the final follow-up visit. The end of the study is defined as the date of the last follow-up visit of the last subject in the study
    Si considera che un soggetto ha completato il trattamento dello studio se il soggetto ha completato tutte le visite fino alla settimana 76 del periodo di trattamento. Si considera che un soggetto ha completato lo studio se il soggetto ha completato tutte le fasi dello studio, inclusa la vista finale di floow-up. La fine dello studio si definisce come la data dell'ultima visita di follow up dell'ultimo soggetto nello studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years6
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    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: 85
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 90
    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)
    After the trial, the patient care will revert to their physicians
    Dopo la sperimentazione la cura del paziente tornerà ai loro medici curanti
    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 Decision2022-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-12
    P. End of Trial
    P.End of Trial StatusOngoing
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