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    Summary
    EudraCT Number:2020-001961-34
    Sponsor's Protocol Code Number:RDG-1/PBC
    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:2021-05-24
    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 number2020-001961-34
    A.3Full title of the trial
    Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis
    Studio randomizzato, in doppio cieco, controllato verso placebo, di fase II per la determinazione del dosaggio, confrontando differenti dosi di RhuDex in granuli verso placebo nel trattamento della colangite biliare primitiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis
    Studio clinico di confronto dell'efficacia e sicurezza di Rhudex in granuli verso placebo nel trattamento della patologia epatica Colangite Biliare Primitiva
    A.3.2Name or abbreviated title of the trial where available
    RhuDex vs placebo in PBC
    RhuDex vs placebo in PBC
    A.4.1Sponsor's protocol code numberRDG-1/PBC
    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 SponsorDR. FALK PHARMA GMBH
    B.1.3.4CountryGermany
    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 supportDr. Falk Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Falk Pharma GmbH
    B.5.2Functional name of contact pointHeadquarters
    B.5.3 Address:
    B.5.3.1Street AddressLeinenweberstr. 5
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79108
    B.5.3.4CountryGermany
    B.5.4Telephone number+4976115140
    B.5.5Fax number+497611514321
    B.5.6E-mailzentrale@drfalkpharma.de
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRhuDex 100 mg (127 mg RhuDex choline salt) granules
    D.3.2Product code [RhuDex choline salt]
    D.3.4Pharmaceutical form Pillules
    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 INNRhuDex choline salt
    D.3.9.2Current sponsor codeRhuDex choline salt
    D.3.9.4EV Substance CodeSUB198105
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number127
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRhuDex 25 mg (31.75 mg RhuDex choline salt) granules
    D.3.2Product code [RhuDex choline salt]
    D.3.4Pharmaceutical form Pillules
    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 INNRhuDex choline salt
    D.3.9.2Current sponsor codeRhuDex choline salt
    D.3.9.4EV Substance CodeSUB198105
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number31
    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 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 nameRhuDex 50 mg (63.5 mg RhuDex choline salt) granules
    D.3.2Product code [RhuDex choline salt]
    D.3.4Pharmaceutical form Pillules
    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 INNRhuDex choline salt
    D.3.9.2Current sponsor codeRhuDex choline salt
    D.3.9.4EV Substance CodeSUB198105
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number63
    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 placeboGastro-resistant granules for oral suspension
    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 primaria
    E.1.1.1Medical condition in easily understood language
    A type of long-term liver disease in which the bile ducts in the liver become damaged.
    Un tipo di malattia epatica a lungo termine in cui i dotti biliari nel fegato vengono danneggiati
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10019805
    E.1.2Term Hepatobiliary disorders
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    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 efficacy of 3 doses of RhuDex vs placebo for the treatment of PBC in patients with an inadequate response to UDCA.
    Valutare l'efficacia di 3 dosi di RhuDex vs placebo per il trattamento della CBP in pazienti con una risposta inadeguata all'UDCA.
    E.2.2Secondary objectives of the trial
    - To identify efficacious RhuDex dose(s) for the treatment of PBC for further evaluation in phase III
    - To study safety and tolerability of RhuDex
    - Identificare la dose(i) di RhuDex efficace per il trattamento della CBP per la valutazione successiva in Fase III
    - Studiare la sicurezza e la tollerabilità di RhuDex
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient is able to understand the information on the trial and has signed the informed consent form,
    - Male or female patients = 18 and < 74 years,
    - PBC verified by at least 2 out of the following 3 criteria (consistent with EASL practice guidelines [2017]):
    • Chronic cholestatic disease (e.g. elevated serum ALP) of at least 6 months duration,
    • Positive AMA titer or presence of PBC-specific antibodies,
    • Liver biopsy compatible with the diagnosis of non-cirrhotic PBC,
    - UDCA treatment for at least 6 months (with a stable dose for = 3 months of at least 12 mg/kg/day) prior to baseline,
    - Serum ALP levels between 1.5x and 10x the upper limit of normal (ULN) at screening,
    - Women of childbearing potential agree to use during the entire duration of the trial and until 4 weeks following the last dose of trial treatment a highly effective method of birth control.
    - Il paziente è in grado di comprendere le informazioni sullo studio e ha firmato il modulo di consenso informato,
    - Pazienti maschi o femmine di età = 18 e <74 anni,
    - CBP confermata da almeno 2 dei 3 seguenti criteri (coerenti con le linee guida EASL [2017]):
    • Colesteasi cronica (ad es. ALP sierica elevata) della durata di almeno 6 mesi,
    • Titolo anticorpale AMA positivo o presenza di anticorpi specifici per CBP,
    • Biopsia epatica compatibile con la diagnosi di CBP non cirrotica,
    - trattamento con UDCA per almeno 6 mesi (con una dose stabile = 3 mesi di almeno 12 mg / kg / giorno) prima del basale,
    - Livelli sierici di ALP compresi tra 1,5 e 10 volte il limite superiore della norma (ULN) allo screening,
    - Le donne in età fertile accettano di utilizzare durante l'intera durata della sperimentazione e fino a 4 settimane dopo l'ultima dose di trattamento un metodo di controllo delle nascite altamente efficace.
    E.4Principal exclusion criteria
    - History or presence of other relevant concomitant liver diseases - Liver cirrhosis
    - History or presence of hepatic decompensation (e.g. variceal bleeding hepatic encephalopathy or poorly controlled ascites),
    - Serum albumin less than 3.2 g/dL, at screening,
    - Any known relevant infectious disease (e.g. active tuberculosis, acquired immunodeficiency syndrome [AIDS]-defining diseases),
    - Abnormal renal function (glomerular filtration rate estimated from cystatin C < 30 mL/min) at screening visit,
    - Thyroid-stimulating hormone (TSH) > ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable if free thyroxine 4 (fT4) is measured and within the normal range),
    - Current history of significant alcohol consumption (> 30 g/day in men, > 20 g/day in women on average) for a period of more than 3 consecutive months within 1 year prior to screening,
    - Any illness or medical conditions that are unstable or could jeopardise the safety of the patient and his/her compliance in the trial or might interfere with the trial results,
    - Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, or any cancer curatively treated < 3 years before trial entry,
    - Existing or intended pregnancy or breast-feeding.
    - Storia o presenza di altre malattie epatiche concomitanti rilevanti - Cirrosi epatica
    - Anamnesi o presenza di scompenso epatico (ad esempio, encefalopatia epatica da sanguinamento da varici o ascite scarsamente controllata),
    - Albumina sierica inferiore a 3,2 g/dL, allo screening,
    - Qualsiasi malattia infettiva rilevante nota (ad es. Tubercolosi attiva, sindrome da immunodeficienza acquisita [AIDS]),
    - Funzionalità renale anormale (velocità di filtrazione glomerulare stimata mediante cistatina C <30 mL / min) alla visita di screening,
    - Ormone tireostimolante (TSH)> ULN allo screening (livelli elevati [4,2-10 µU / mL] sono accettabili se viene misurata la tiroxina libera 4 (fT4) e rientra nell'intervallo normale),
    - Storia di consumo significativo di alcol (> 30 g/giorno negli uomini,> 20 g/giorno nelle donne in media) per un periodo di oltre 3 mesi consecutivi nell'anno precedente lo screening,
    - Qualsiasi malattia o condizione medica instabile o che possa mettere a rischio la sicurezza del paziente e la sua adesione allo studio o che possa interferire con i risultati dello studio,
    - Precedente o concomitante malattia tumorale ad eccezione del carcinoma cervicale in situ, carcinoma basocellulare trattato o qualsiasi tumore trattato con terapia curativa <3 anni prima dell'ingresso nello studio,
    - Gravidanza o allattamento in atto o previste.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    • Relative change (%) in Alkaline phosphatase (ALP) from baseline to End Of Trial (EoT).

    Safety Endpoints:
    • Adverse Events,
    • Vital signs (blood pressure, heart rate), body temperature, body weight and BMI,
    • Haematology, serum chemistry, urinalysis, coagulation,
    • ECG parameters (12 leads),
    • Patient's tolerability of the IMP.
    End point primario di Efficacia:
    • Variazione relativa (%) della fosfatasi alcalina (ALP) dal basale fino alla fine del periodo di trattamento (EoT).

    End point di Sicurezza:
    • Eventi avversi,
    • Segni vitali (pressione sanguigna, frequenza cardiaca), temperatura corporea, peso e BMI,
    • Ematologia, sierologico, analisi delle urine, coagulazione,
    • Parametri ECG (12 derivazioni),
    • Tollerabilità dell'IMP da parte del paziente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Tutta la durata dello studio
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    - ALP at each trial visit (screening to follow-up),
    - Absolute and relative changes (%) of ALP from baseline to each visit up to EOT, and from EOT to the follow-up visit,
    - gamma-GT, AST, ALT, and total and conjugated bilirubin levels at each trial visit (screening to follow-up),
    - Absolute and relative changes (%) of gamma-GT, AST, ALT and total and conjugated bilirubin levels from baseline to each visit up to EOT, and from EOT to the follow-up visit.; End point secondari di Efficacia:
    - ALP ad ogni visita (dallo screening al follow-up)
    - Variazione assoluta e relativa (%) di ALP dal baseline a ciascuna visita fino all' EOT, e dall' EOT alla visita di follow-up
    - livelli di gamma-GT, AST, ALT e bilirubina totale e coniugata ad ogni visita di studio (dallo screening al follow-up),
    - Variazioni assolute e relative (%) di gamma-GT, AST, ALT e livelli di bilirubina totale e coniugata dal basale a ciascuna visita fino all' EOT e dall' EOT alla visita di follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study; Tutta la durata 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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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) No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 months3
    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: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 136
    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)
    Follow up visit occurring 4 weeks after receiving the last dose of study medication. Treatment after trial end is left to the investigator's discretion.
    Visita di follow-up 4 settimane dopo aver ricevuto l'ultima dose del farmaco in studio.
    La scelta del trattamento dopo la fine dello studio è lasciata alla discrezione dello sperimentatore.
    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 Decision2021-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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