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    Summary
    EudraCT Number:2020-005198-29
    Sponsor's Protocol Code Number:CB8025-31731-RE
    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:2021-06-08
    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 number2020-005198-29
    A.3Full title of the trial
    ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
    ASSURE: Studio in aperto a lungo termine per valutare la sicurezza e tollerabilità di Seladelpar in soggetti affetti da colangite biliare primitiva (PBC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis
    Studio per valutare la sicurezza e tollerabilità di Seladelpar in soggetti affetti da colangite biliare primitiva
    A.3.2Name or abbreviated title of the trial where available
    ASSURE
    ASSURE
    A.4.1Sponsor's protocol code numberCB8025-31731-RE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03301506
    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 pointStacy Meluskey
    B.5.3 Address:
    B.5.3.1Street Address7575 Gateway Blvd. Suite 110
    B.5.3.2Town/ cityNewark
    B.5.3.3Post codeCA 94560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+15102938141
    B.5.5Fax number+15102938133
    B.5.6E-mailsmeluskey@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 numberEU/3/17/1930
    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 codeMBX-8025
    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 numberEU/3/17/1930
    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 codeMBX-8025
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Biliary Cholangitis
    Colangite Biliare Primaria
    E.1.1.1Medical condition in easily understood language
    A long-term liver disease in which the bile ducts in the liver become damaged. This gradually leads to a build-up of bile in the liver, which can damage it and eventually lead to scarring.
    Malattia del fegato a lungo termine in cui i dotti biliari nel fegato vengono danneggiati portando gradualmente a un accumulo di bile nel fegato, che può danneggiarlo e alla fine portare a cicatrici.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    To evaluate the long-term safety and tolerability of seladelpar
    Valutare la sicurezza e la tollerabilità a lungo termine di seladelpar
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy of seladelpar, and the effect of seladelpar on patient-reported outcomes (pruritus)
    Per valutare l'efficacia a lungo termine di seladelpar e l'effetto di seladelpar sugli esiti riportati dai pazienti (prurito)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have given informed consent (signed and dated)
    2. Participated in a previous PBC study with seladelpar (including CB8025-21629, CB8025-31735, or CB8025-21838) or future PBC studies with seladelpar that allow rollover into CB8025-31731-RE, or were previously enrolled in study CB8025-31731 prior to the early termination of the study, and meet eligibility criteria for the current study.
    3. 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. I soggetti devono aver fornito il consenso informato scritto (firmato e datato)
    2. I soggetti devono aver partecipato a un precedente studio sulla PBC con seladelpar (compresi CB8025 21629, CB8025 31735 o CB8025-21838) o a studi futuri sulla PBC con seladelpar che consentono il roll-over nello studio CB8025-31731-RE, o essersi precedentemente arruolati nello studio CB8025 31731 prima dell’interruzione anticipata dello studio, e soddisfino i criteri di eleggibilità per lo studio attuale.
    3. I soggetti di sesso femminile in età fertile devono utilizzare almeno un metodo contraccettivo di barriera e un secondo metodo contraccettivo efficace durante lo studio e per almeno 90 giorni dopo l’ultima dose. I soggetti di sesso maschile sessualmente attivi con partner di sesso femminile in età fertile devono utilizzare 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
    Exclusion criteria are only applicable for subjects with a study drug interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption
    1. Treatment-related AE leading to study drug discontinuation in a previous PBC study with seladelpar
    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 or ALT above 3 × ULN
    4. Total bilirubin above 2 × ULN
    5. Model for End-Stage Liver Disease (MELD) score > = 15
    6. Evidence of advanced PBC as defined by the Rotterdam criteria (albumin below 1 × lower limit of normal AND total bilirubin above 1 × ULN)
    7. Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 (calculated by Modification of Diet in Renal Disease formula)
    8. Auto-immune hepatitis
    9. Primary sclerosing cholangitis
    10. Known history of alpha-1-antitrypsin deficiency
    11. Known history of chronic viral hepatitis
    12. For females, pregnancy or breast-feeding
    13. Use of colchicine, methotrexate, azathioprine or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
    14. Current use of fibrates or use of fibrates within 3 months prior to Screening
    15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
    16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
    17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
    18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
    19. 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
    I criteri di esclusione sono applicabili solo per i soggetti con un’interruzione della dose del farmaco in studio da più di 4 settimane prima al Giorno 1 di questo studio e per i soggetti che hanno partecipato allo studio CB8025-21838 indipendentemente dall’interruzione della dose di seladelpar.
    1. Evento avverso (EA) correlato al trattamento che ha portato all’interruzione del farmaco in studio in un precedente studio sulla PBC con seladelpar
    2. Una condizione medica diversa da PBC che, a giudizio dello sperimentatore, precluderebbe la partecipazione allo studio o ne confonderebbe i risultati (per es. tumore)
    3. Livelli di AST o ALT al di sopra di 3 × il limite superiore della norma (Upper Limit of Normal, [ULN])
    4. Bilirubina totale al di sopra di 2 × ULN
    5. Punteggio MELD > =15
    6. Evidenza di PBC in stadio avanzato, come definita dai criteri di Rotterdam (albumina al di sotto di 1 × il limite inferiore alla norma E bilirubina totale superiore a 1 × ULN)
    7. Velocità di filtrazione glomerulare stimata al di sotto di 60 ml/min/1,73 m2 (calcolata mediante la formula della Modifica della dieta nella malattia renale)
    8. Epatite autoimmune
    9. Colangite sclerosante primitiva
    10. Anamnesi nota di deficit di alfa-1-antitripsina
    11. Anamnesi nota di epatite virale cronica
    12. Per i soggetti di sesso femminile, gravidanza o allattamento al seno
    13. Uso di colchicina, metotrexato, azatioprina o uso a lungo termine (>2 settimane) di steroidi sistemici (ad es., prednisone, prednisolone, budesonide) nei 2 mesi precedenti lo screening
    14. Uso attuale di fibrati o uso di fibrati nei 3 mesi precedenti lo screening
    15. Uso attuale di acido obeticolico o uso di acido obeticolico nei 3 mesi precedenti lo screening
    16. Uso di un trattamento sperimentale o non approvato per la PBC nei 3 mesi precedenti lo screening
    17. Anamnesi di neoplasia maligna diagnosticata o trattata, attiva o entro 2 anni, o valutazione in corso per neoplasia maligna; il trattamento localizzato di tumori della pelle a cellule basali o squamose non invasivi e di carcinoma cervicale in situ è ammesso se somministrato adeguatamente prima dello screening
    18. Trattamento con qualsiasi altra terapia o dispositivo medico sperimentale entro 30 giorni o entro 5 emivite, a seconda di quale periodo è più lungo, prima dello screening
    19. Qualsiasi altra condizione che potrebbe compromettere la sicurezza del soggetto o la qualità dello studio clinico, secondo il giudizio dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    Treatment-emergent AEs (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0), biochemistry and hematology results are collected
    Eventi avversi emergenti dal trattamento (Treatment Emergent Adverse Event, [TEAE]) (in base ai Criteri terminologici comuni per gli eventi avversi del National Cancer Institute, Versione 5.0), risultati di biochimica ed ematologia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    per tutto lo studio
    E.5.2Secondary end point(s)
    1. Occurrence of the following adjudicated PBC clinical outcomes:
    -Overall death
    -Liver transplantation
    -MELD score > = 15 for at least 2 consecutive visits
    -Ascites requiring treatment
    -Hospitalization for new onset or recurrence, of any:
    -Variceal bleeding, Hepatic encephalopathy (as defined by a West Haven score > = 2), Spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
    2. Biochemical markers:
    -Response on composite of ALP and total bilirubin
    -Proportion of subjects with normalization of ALP
    -Relative and absolute changes of the following:
    -Alkaline phosphatase (ALP)
    -Aspartate aminotransferase (AST)
    -Alanine aminotransferase (ALT)
    -Gamma-glutamyl transferase (GGT)
    -Bilirubin (total, direct, indirect)
    3. Change from Baseline in pruritus NRS
    1. Insorgenza dei seguenti esiti clinici di PBC convalidati:
    o Mortalità complessiva
    o Trapianto di fegato
    o Punteggio del Modello per la malattia epatica allo stadio terminale (Model for End-Stage Liver Disease, [MELD]) > =15 per almeno 2 visite consecutive
    o Ascite che necessita trattamento
    o Ricovero ospedaliero per nuova insorgenza o recidiva di uno qualsiasi tra:
    - Emorragia varicosa
    - Encefalopatia epatica (definita da un punteggio West Haven > =2)
    - Peritonite batterica spontanea (confermata da coltura da paracentesi diagnostica)
    2. Marcatori biochimici:
    o Risposta sull’endpoint composito di fosfatasi alcalina (Alkaline Phosphatase, [ALP]) e bilirubina totale
    o Percentuale di soggetti con normalizzazione dei livelli di ALP
    o Variazioni relative e assolute nei livelli di ALP, aspartato aminotransferasi (AST), alanina aminotransferasi (ALT), gamma-glutamil transferasi, bilirubina (totale, diretta, indiretta)
    3. Variazione rispetto al basale nella scala di valutazione numerica (Numerical Rating Scale, [NRS]) per il prurito
    Esplorativi:
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    per tutta la sperimentazione
    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 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) Yes
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    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
    Chile
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    United States
    Belgium
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Spain
    United Kingdom
    Argentina
    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 years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 428
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 500
    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)
    Study duration is until seladelpar is commercially available or the program is discontinued.
    La durata dello studio è fino a quando seladelpar non è disponibile in commercio o il programma viene interrotto.
    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 Decision2021-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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