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    Summary
    EudraCT Number:2022-001241-20
    Sponsor's Protocol Code Number:747-214
    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:2022-09-14
    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 number2022-001241-20
    A.3Full title of the trial
    A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subjects with Primary Biliary Cholangitis
    Studio di fase 2a, in doppio cieco, randomizzato, con controllo attivo, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilità del bezafibrato somministrato in combinazione con acido obeticolico in soggetti con colangite biliare primitiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).
    Studio per determinare se il farmaco sperimentale acido obeticolico (noto anche come OCA) in combinazione con il farmaco sperimentale bezafibrato (BZF) ha un effetto sulla colangite biliare primitiva (nota anche come PBC).
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number747-214
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05239468
    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 SponsorINTERCEPT 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 supportIntercept Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLabcorp Drug Development Limited
    B.5.2Functional name of contact pointGlobal Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressOsprey House, Maidenhead Office Park, Westacott Way
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 3QH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailsubmissions@labcorp.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 Ocaliva 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderIntercept Pharma International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/10/753
    D.3 Description of the IMP
    D.3.1Product nameObeticholic Acid
    D.3.2Product code [-]
    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 INNACIDO OBETICOLICO
    D.3.9.1CAS number 459789-99-2
    D.3.9.2Current sponsor code6-ECDCA
    D.3.9.3Other descriptive namealpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
    D.3.9.4EV Substance CodeSUB91981
    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 RoleComparator
    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 nameBezafibrate
    D.3.2Product code [-]
    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 INNBezafibrate
    D.3.9.1CAS number 41859-67-0
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameBezafibrate, Beza, BZF, Bezalip
    D.3.9.4EV Substance CodeSUB05810MIG
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 nameBezafibrate
    D.3.2Product code [-]
    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 INNBezafibrate
    D.3.9.1CAS number 41859-67-0
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameBezafibrate, Beza, BZF, Bezalip
    D.3.9.4EV Substance CodeSUB05810MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 2
    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
    Primary Biliary Cholangitis
    Colangite biliare primitiva
    E.1.1.1Medical condition in easily understood language
    Primary Biliary Cholangitis
    Colangite biliare primitiva
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080429
    E.1.2Term Primary biliary cholangitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    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 is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to BZF alone in subjects with PBC
    L'obiettivo primario è quello di valutare gli effetti della combinazione di OCA più BZF sulla fosfatasi alcalina (ALP) rispetto al solo BZF in soggetti con colangite biliare primitiva (PBC)
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effects of the combination of OCA plus BZF versus BZF alone in subjects with PBC on the following:
    • Biochemical disease markers, including ALP, GGT, ALT, AST, total and conjugated bilirubin, and lipid panel
    • Biomarkers of bile acid synthesis and homeostasis, including 7a-hydroxy-4-cholesten-3-one (C4) and bile acids
    • Safety and tolerability
    Gli obiettivi secondari sono atti a valutare gli effetti della combinazione di OCA più BZF rispetto a BZF da solo in soggetti con PBC su quanto segue:
    • Marcatori biochimici della malattia, inclusi ALP, GGT, alanina aminotransferasi (ALT), aspartato aminotransferasi (AST), bilirubina totale e coniugata e pannello lipidico
    • Biomarcatori della sintesi e dell'omeostasi degli acidi biliari, inclusi 7a-idrossi-4 colesteno-3-one (C4) e acidi biliari
    • Sicurezza e tollerabilità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A define or probable diagnosis of PBC
    2. Qualifying ALP and/or bilirubin liver biochemistry values
    3. Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1

    1. Una diagnosi certa o probabile di PBC
    2. Valori biochimici qualificanti di fosfatasi alcalina e/o bilirubina
    3. Assunziona di acido ursodesossicolico (UDCA) per almeno 12 mesi o senza UDCA per 3 mesi prima del Giorno 1
    E.4Principal exclusion criteria
    1. History or presence of other concomitant liver diseases
    2. Presence of clinical complications of PBC
    3. History or presence of decompensating events
    4. Current or history of gallbladder disease
    5. If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
    6. Treatment with commercially available OCA or participation in a previous study involving OCA within 3 months before Screening
    7. Treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening


    1. Anamnesi o presenza di altre malattie epatiche concomitanti
    2. Presenza di complicanze cliniche della PBC
    3. Anamnesi o presenza di eventi scompensanti
    4. Malattie della cistifellea passate o in corso
    5. Nei soggetti di sesso femminile, gravidanza nota o test di gravidanza sulle urine positivo (confermato da test di gravidanza su siero positivo), o allattamento
    6. Trattamento con OCA disponibile in commercio o partecipazione a uno studio precedente con OCA nei 3 mesi precedenti lo screening
    7. Trattamento con fibrati disponibili in commercio, o partecipazione a uno studio precedente con fibrati nei 3 mesi precedenti lo screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in ALP from baseline to Week 12 in the DB Phase.
    L'endpoint primario di efficacia è la variazione di fosfatasi alcalina (ALP) dal basale alla Settimana 12 nella fase di trattamento in doppio cieco (DB phase).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    Dal basale alla Settimana 12
    E.5.2Secondary end point(s)
    - Safety and tolerability
    - The response rates of >=10%, >=20%, >=30%, and >=40% reduction from baseline at Week 12, and normalization rates of ALP at Week 12
    - Normalization rates at Week 12 of GGT, ALT, AST, total and conjugated bilirubin, and lipid panel
    - Change from baseline to Week 12 in GGT, ALT, AST, and total and conjugated bilirubin, and lipid panel
    - Change from baseline to Week 12 in 7a-hydroxy-4-cholesten-3-one (C4) and bile acids
    - Sicurezza e tollerabilità
    - I tassi di risposta di ALP di >=10%, >=20%, >=30%, e >=40% di riduzione rispetto al basale alla Settimana 12, e i tassi di normalizzazione di ALP alla settimana 12
    - I tassi di normalizzazione alla Settimana 12 di GGT, ALT, AST, bilirubina totale e coniugata e pannello lipidico
    - Variazione dal basale alla settimana 12 di GGT, ALT, AST, bilirubina totale e coniugata e pannello lipidico
    - Varazione dal basale alla settimana 12 di 7a-idrossi-4 colesteno-3-one (C4) e acidi biliari
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to end of study
    Dal basale fino alla fine dello studio
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 No
    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
    Canada
    United States
    Turkey
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 55
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    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 Decision2022-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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