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    Summary
    EudraCT Number:2018-001171-20
    Sponsor's Protocol Code Number:CB8025-31735
    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:2021-06-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001171-20
    A.3Full title of the trial
    A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the
    safety and efficacy of seladelpar in subjects with primary biliary cholangitis
    (PBC) and an inadequate response to or intolerance to ursodeoxycholic
    acid (UDCA).
    Studio di fase 3, di 52 settimane, randomizzato, controllato con placebo,
    per valutare la sicurezza e l'efficacia di seladelpar in soggetti affetti da
    colangite biliare primitiva (CBP) che presentano una risposta inadeguata o
    intolleranza all'acido ursodesossicolico (UDCA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess the safety and efficacy of seladelpar in patients
    with primary biliary cholangitis (PBC) and an inadequate response to or
    intolerance to ursodeoxycholic acid (UDCA).
    Studio clinico per valutare la sicurezza e l'efficacia di seladelpar in soggetti
    affetti da colangite biliare primitiva (CBP) che presentano una risposta
    inadeguata o intolleranza all'acido ursodesossicolico (UDCA).
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCB8025-31735
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03602560
    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 SponsorCymaBay Therapeutics, 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 supportCymaBay Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCymaBay Therapeutics, Inc.
    B.5.2Functional name of contact pointSenior VP, RA&QA - Klara Dickinson
    B.5.3 Address:
    B.5.3.1Street Address7575 Gateway Boulevard Suite 110
    B.5.3.2Town/ cityNewark
    B.5.3.3Post code94560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+15102938836
    B.5.5Fax number+15102938133
    B.5.6E-mailkdickinson@cymabay.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 Yes
    D.2.5.1Orphan drug designation numberEU3/17/1930
    D.3 Description of the IMP
    D.3.1Product nameseladelpar
    D.3.2Product code [MXB-8025]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSELADELPAR
    D.3.9.1CAS number 928821-40-3
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB192392
    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: 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 numberEU3/17/1930
    D.3 Description of the IMP
    D.3.1Product nameSeladelpar
    D.3.2Product code [MBX-8025]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNseladelpar
    D.3.9.1CAS number 928821-40-3
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB192392
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Primary biliary cholangitis (PBC, formerly known as primary biliary
    cirrhosis) is a serious and potentially life threatening autoimmune
    disease of the liver characterized by impaired bile flow (cholestasis) and
    accumulation of toxic bile acids (BA).
    La colangite biliare primitiva (PBC, precedentemente nota come cirrosi
    biliare primaria) è una malattia autoimmune grave e potenzialmente
    pericolosa per la vita del fegato caratterizzata da alterato flusso biliare
    (colestasi) e accumulo di acidi biliari tossici (BA).
    E.1.1.1Medical condition in easily understood language
    Disease of the liver
    Malattia del fegato
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10036680
    E.1.2Term Primary biliary cirrhosis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and effect on cholestasis of two seladelpar regimens
    (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of
    treatment compared to placebo.
    Valutare la sicurezza e l'effetto sulla colestasi di due regimi a base di
    seladelpar (5 mg / die titolati a 10 mg / die e 10 mg / die) nell'arco di
    52 settimane di trattamento rispetto al placebo.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of seladelpar on normalization of alkaline phosphate
    (AP) levels and to evaluate the effect of seladelpar on pruritus.
    Evaluate the effect of seladelpar on quality of life (QoL), to evaluate the
    effect of seladelpar on other measures of cholestasis, metabolic
    outcomes, PBC prognosis criteria, and the effect of seladelpar on PBC
    clinical outcomes.
    Valutare l'effetto di seladelpar sulla normalizzazione dei livelli di
    fosfatasi alcalina (AP) e valutare l'effetto di seladelpar sul prurito.
    Valutare l'effetto di seladelpar sulla qualità della vita (QoL), valutare
    l'effetto di seladelpar su altre misure della colestasi, esiti metabolici e i
    criteri di prognosi di CBP e valutare l'effetto di seladelpar sugli esiti
    clinici della CBP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have given written informed consent (signed and dated) and any
    authorizations required by local law
    2. 18 to 75 years old (inclusive)
    3. Male or female with a diagnosis of PBC, by at least two of the
    following criteria:
    • History of AP above ULN for at least 6 months
    • Positive anti-mitochondrial antibody (AMA) titers (>1/40 on
    immunofluorescence or M2 positive by enzyme linked immunosorbent
    assay [ELISA]) or positive PBC-specific antinuclear antibodies
    • Documented liver biopsy result consistent with PBC
    4. On a stable and recommended dose of UDCA for the past 12 months
    OR intolerant to UDCA (last dose of UDCA > 3 months prior to Screening)
    5. AP > 1.67 × ULN
    6. Females of reproductive potential must use at least one barrier
    contraceptive and a second effective birth control method during the
    study and for at least 90 days after the last dose. Male subjects who are
    sexually active with female partners of reproductive potential must use
    barrier contraception and their female partners must use a second
    effective birth control method during the study and for at least 90 days
    after the last dose
    1.Avere dato il consenso informato scritto (firmato e datato) e tutte le
    autorizzazioni richieste in base alla legge locale
    2.Da 18 a 75 anni di età (inclusi)
    3.Maschio o femmina con una diagnosi di CBP, in base ad almeno due dei
    seguenti criteri:
    •Anamnesi di AP superiore a ULN da almeno sei mesi
    •Titoli positivi dell'anticorpo anti-mitocondriale (AMA) ( >1/40 in base a
    dosaggio a immunofluorescenza o M2 positivo in base a dosaggio
    immunoassorbente legato a un enzima [ELISA]) o anticorpi antinucleari
    CBP specifici positivi
    •Risultato di biopsia epatica documentato coerente con CBP
    4.In trattamento con dose stabile e raccomandata di UDCA per gli ultimi
    dodici mesi O intolleranza a UDCA (ultima dose di UDCA > 3 mesi prima
    dello screening)
    5.AP> 1,67 × ULN
    6.Le donne in età fertile devono utilizzare almeno un metodo
    contraccettivo di barriera efficace e un secondo metodo contraccettivo
    durante lo studio e per almeno 90 giorni dopo l'ultima dose. I soggetti di
    sesso maschile che sono sessualmente attivi con partner di sesso
    femminile in età fertile devono usare metodi contraccettivi di barriera e
    le loro partner devono utilizzare un secondo metodo contraccettivo
    efficace durante lo studio e per almeno 90 giorni dopo l'ultima dose.
    E.4Principal exclusion criteria
    1. Previous exposure to seladelpar (MBX-8025)
    2. A medical condition, other than PBC, that in the investigator's opinion
    would preclude full participation in the study or confound its results
    (e.g., cancer)
    3. AST above 3 × ULN
    4. ALT above 3 × ULN
    5. Total bilirubin above 2.0 × ULN
    6. Advanced PBC as defined by the Rotterdam criteria (albumin below
    LLN AND total bilirubin above 1 × ULN
    7. Creatine kinase (CK) above 1.0 × ULN
    8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula) 7. Serum creatinine above 1.0 × ULN
    9. International normalized ratio (INR) above 1.0 × ULN
    10. Platelet count below 100 × 103/µL
    11. Presence of clinically significant hepatic decompensation, including:
    - History of liver transplantation, current placement on liver
    transplantation list, or current Model for End-Stage Liver Disease (MELD)
    score >15
    - Complications of portal hypertension, including known esophageal
    varices, history of variceal bleeds or related interventions (e.g.,
    transjugular intrahepatic portosystemic shunt placement), relevant
    ascites, hepatic encephalopathy
    - Cirrhosis with complications, including history or presence of
    spontaneous bacterial peritonitis
    12. Other chronic liver diseases:
    a.Current features of auto-immune hepatitis as determined by the
    investigator based on immunoserology, liver biochemistry and histology
    b.Primary sclerosing cholangitis determined by presence of diagnostic
    cholangiographic findings
    c.History or clinical evidence of alcoholic liver disease
    d.History or clinical evidence of alpha-1-antitrypsin deficiency
    e.Biopsy confirmed nonalcoholic steatohepatitis
    f.History or evidence of Gilbert' Syndrome with elevated total bilirubin
    g.History or evidence of hemochromatosis
    h.Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
    i.Hepatitis C defined as presence of HCV RNA
    13. Known history of HIV
    14. Evidence of significant alcohol consumption
    15. Evidence of drug abuse
    16. Subjects with inadequate response to obeticholic acid (OCA) or
    intolerance to OCA: OCA must be discontinued 30 days prior to Screening
    17. Use of colchicine, methotrexate, azathioprine, or long-term systemic
    corticosteroids (> 2 weeks) within two months prior to Screening
    18. Use of fibrates within 30 days prior to Screening
    19. Use of simvastatin within 7 days prior to Screening
    20. Use of an experimental or unapproved treatment for PBC within 30
    days prior to Screening
    21. Use of experimental or unapproved immunosuppressant within 30
    days prior to Screening
    22. Treatment with any other investigational therapy or device within 30
    days or within five half-lives, whatever is longer, prior to Screening
    23. For females, pregnancy or breast-feeding
    24. Any other condition(s) that would compromise the safety of the
    subject or compromise the quality of the clinical study, as judged by the
    investigator.
    1.Precedente esposizione a seladelpar (MBX-8025)
    2.Una condizione medica, diversa da CBP, che in base all'opinione dello
    sperimentatore potrebbe precludere la piena partecipazione allo studio o
    confonderne i risultati (ad es., cancro)
    3.AST superiore a 3 × ULN
    4.ALT superiore a 3 × ULN
    5.Bilirubina totale superiore a 2,0 × ULN
    6.CBP avanzata come definito dai criteri di Rotterdam (albumina al di
    sotto del LLN e bilirubina totale superiore a 1 × ULN)
    7.Creatinchinasi (CK) superiore a 1,0 × ULN
    8.eGFR inferiore a 60 ml/min/1,73 m2 (calcolata in base alla formula
    MDRD)
    9.Rapporto internazionale normalizzato (INR) superiore a 1,0 x ULN
    10.Conta piastrinica al di sotto di 100 x 103/µl
    11.Presenza di scompenso epatico significativo da un punto di vista
    clinico, che include:
    -Anamnesi di trapianto di fegato, presenza attuale sulla lista dei trapianti di fegato o attuale punteggio MELD>15
    -Complicanze dell'ipertensione portale, tra cui varici esofagee note,
    anamnesi di emorragie delle varici o interventi correlati (ad es.,
    inserimento di shunt portosistemico intraepatico transgiugulare), asciti
    rilevanti, encefalopatia epatica
    -Cirrosi con complicanze, quali anamnesi o presenza di peritonite
    batterica spontanea
    12.Altre malattie epatiche croniche:
    a.Caratteristiche correnti di epatite autoimmune come stabilito dallo
    sperimentatore in base ad analisi di immunosierologia, biochimica
    epatica e istologia
    b.Colangite sclerosante primaria determinata dalla presenza di reperti
    colangiografici diagnostici
    c.Anamnesi o evidenza clinica di malattia epatica alcolica
    d.Anamnesi o evidenza clinica di deficit di alfa-1-antitripsina
    e.Steatoepatite non alcolica confermata da biopsia
    f.Anamnesi o evidenza di sindrome di Gilbert con bilirubina totale elevata
    g.Anamnesi o evidenza di emocromatosi
    h.Epatite B definita come presenza dell'antigene di superficie dell'epatite
    B (HBsAg)
    i.Epatite C definita come presenza di HCV RNA
    13.Storia nota di HIV
    14.Evidenza di notevole consumo di alcool
    15.Evidenza di abuso di droghe
    16.Soggetti con risposta inadeguata all'acido obeticolico (OCA) o
    intolleranza ad OCA: Il trattamento con OCA deve essere interrotto 30
    giorni prima dello Screening
    17.Uso di colchicina, metotrexato, azatioprina, oppure corticosteroidi
    sistemici a lungo termine (> 2 settimane) entro due mesi prima dello
    Screening
    18.Uso di fibrati entro 30 giorni prima dello Screening
    19.Uso di simvastatina entro 7 giorni prima dello Screening
    20.Utilizzo di un trattamento sperimentale o non approvato per il
    trattamento della CBP entro 30 giorni prima dello Screening
    21.Uso di immunosoppressori sperimentali o non approvati entro 30
    giorni prima dello Screening
    22.Trattamento con qualsiasi altra terapia o dispositivo sperimentale
    entro 30 giorni o entro cinque emivite prima dello Screening, a seconda
    di quale sia il periodo più lungo
    23.Per le donne, stato di gravidanza o allattamento
    24.Qualsiasi altra/e patologia/e che comprometterebbe/ro la sicurezza
    del soggetto o comprometterebbe/ro la qualità dello studio clinico, in
    base all'opinione dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    1 - Response on the composite endpoint of AP and total bilirubin at 12
    months:
    o AP < 1.67 × ULN,
    o > 15% decrease in AP, and
    o Total bilirubin = ULN
    2 - Assessment of treatment-emergent AEs (TEAEs) (National Cancer
    Institute [NCI] Common Terminology Criteria for Adverse Events
    [CTCAE] Version 4.0), biochemistry and hematology
    1-Risposta all'endpoint composito di AP e bilirubina totale a 12 mesi:
    -AP < 1,67 × limite superiore della norma (ULN) e
    -diminuzione di AP > 15% e
    -Bilirubina totale = ULN
    2-Valutazione degli effetti avversi emergenti dal trattamento (TEAE)
    (Criteri Terminologici Comuni per gli Eventi Avversi [CTCAE] del National
    Cancer Institute [NCI] Versione 4.0), analisi biochimiche ed
    ematologiche
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- 12 months
    2 - Throughout the study
    1-12 mesi
    2-Durante lo studio
    E.5.2Secondary end point(s)
    1 - Proportion of patients with AP=1.0 × ULN at 12 months
    2 - Change from baseline in pruritus NRS at 6 months
    1 -Proporzione dei pazienti con AP=1,0 × ULN a 12 mesi
    2-variazione rispetto alla baseline nella scala di valutazione numerica del
    prurito (NRS) a 6 mesi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 12 months
    2 - 6 months
    1- 12 mesi
    2- 6 mesi
    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 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) 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 trial3
    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 EEA70
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    United Kingdom
    United States
    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
    At the end of 52 weeks of treatment, subjects will be invited to
    participate in the long-term study (CB8025-31731) and continue their
    treatment with seladelpar; subjects on placebo will be switched to
    seladelpar. Subjects who do not want to continue seladelpar treatment
    beyond 52 weeks and decline long-term study participation will have a
    follow-up visit performed 4 weeks after the last dose of the study drug.
    Alla fine delle 52 settimane di trattamento, i soggetti saranno invitati a
    partecipare allo studio a lungo termine (CB8025-31731) e continuare il
    trattamento con seladelpar; i soggetti che assumono placebo
    passeranno a seladelpar. I soggetti che non desiderano continuare il trattamento con seladelpar oltre le 52 settimane e rifiutano la
    partecipazione allo studio a lungo termine avranno una visita di followup
    eseguita 4 settimane dopo l'ultima dose del farmaco in studio. ontinuare il
    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 months3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 146
    F.4.2.2In the whole clinical trial 240
    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)
    At the end of 52 weeks of treatment, subjects will be invited to
    participate in the long-term study (CB8025-31731) and continue their
    treatment with seladelpar; subjects on placebo will be switched to
    seladelpar. Subjects who do not want to continue seladelpar treatment
    beyond 52 weeks and decline long-term study participation will have a
    follow-up visit performed 4 weeks after the last dose of the study drug.
    Alla fine delle 52 settimane di trattamento, i soggetti saranno invitati a
    partecipare allo studio a lungo termine (CB8025-31731) e continuare il
    trattamento con seladelpar; i soggetti che assumono placebo
    passeranno a seladelpar. I soggetti che non desiderano continuare il
    trattamento con seladelpar oltre le 52 settimane e rifiutano la partecipazione allo studio a lungo termine avranno una visita di followup
    eseguita 4 settimane dopo l'ultima dose del farmaco in studio.
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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