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    Summary
    EudraCT Number:2016-003367-19
    Sponsor's Protocol Code Number:NUC5/PSC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2026-04-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-003367-19
    A.3Full title of the trial
    Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis
    Ensayo doble ciego, aleatorizado, controlado con placebo, de fase III, que compara cápsulas de ácido norursodesoxicólico con placebo en el tratamiento de la colangitis esclerosante primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis
    Un estudio para comparar el ácido norursodesoxicólico con placebo en el tratamiento de la colangitis esclerosante primaria
    A.4.1Sponsor's protocol code numberNUC5/PSC
    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 pointDepartment of Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressLeinenweberstrasse 5
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79108
    B.5.3.4CountryGermany
    B.5.4Telephone number004976115140
    B.5.5Fax number00497611514377
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1288
    D.3 Description of the IMP
    D.3.1Product nameNorursodeoxycholic acid
    D.3.4Pharmaceutical form Capsule
    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 INNNorursodeoxycholic acid
    D.3.9.1CAS number 99697-24-2
    D.3.9.2Current sponsor codeNorUDCA
    D.3.9.3Other descriptive nameNorUDCA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    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 Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis.
    E.1.1.1Medical condition in easily understood language
    Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic liver disease characterized by changes in the gall ducts inside and/or outside the liver, such as narrowing or enlargement.
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036732
    E.1.2Term Primary sclerosing cholangitis
    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 show the superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) with regard to prevention of disease progression.
    Mostrar la superioridad del ácido norursodesoxicólico (norUDCA) frente al placebo en el tratamiento de la colangitis esclerosante primaria (CEP) con respecto a la prevención de la progresión de la enfermedad, evaluada mediante análisis histológicos del hígado y la normalización parcial de las concentraciones de fosfatasa alcalina en suero (s-ALP) en pacientes con CEP
    E.2.2Secondary objectives of the trial
    To study safety and tolerability (Adverse Events, laboratory parameters) of norUDCA,
    To assess quality of life.
    Estudiar la seguridad y tolerabilidad (acontecimientos adversos, parámetros de laboratorio) de norUDCA;
    • Evaluar la calidad de vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent.
    2. Males or females.
    3. Verified PSC.
    4. Liver biopsy available.
    8. Women of child-bearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as combined (estrogen and progestogen
    containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized
    partner, or sexual abstinence (only accepted as a highly effective contraceptive measure if it is the usual and preferred lifestyle of the patient), throughout the treatment period and for four weeks following the last dose of study drug. Hormonal methods other than levonorgestrel containing devices or medroxyprogesterone injections should be
    supplemented with use of a male condom. Women of non-childbearing potential may be included if surgically sterile or post-menopausal for at least 2 years. The investigator is responsible for determining whether the patient has this adequate birth control for study participation.
    Consentimiento informado firmado.
    2. Hombres o mujeres ≥ 16* y ≤ 75 años. La inclusión de menores podría no estar permitida en algunos países (p. ej., Alemania, Dinamarca, Francia) en virtud de la reglamentación local.
    3. CEP verificada por medio de colangiografía retrógrada, operativa, percutánea o por resonancia magnética que muestra alteraciones intrahepáticas o extrahepáticas del conducto biliar, p. ej. en cuentas de rosario o estenosis, compatibles con CEP dentro del año precedente al inicio del ensayo.
    4. Biopsia hepática (en los 2 meses previos al inicio del ensayo) disponible para revisión.
    5. En caso de tratamiento previo con ácido ursodesoxicólico (UDCA), dosis estable de UDCA durante ≥ 3 meses antes del inicio del ensayo, sin que superara 20 mg/kg/d.
    6. Fosfatasa alcalina > 1,5 veces el límite superior de normalidad (LSN) en la visita exploratoria.
    7. Los pacientes con CEP, con o sin enfermedad inflamatoria intestinal (EII; los pacientes sin exclusión diagnóstica definitiva de EII se deben someter a una colonoscopia con biopsia segmentaria antes de la visita inicial); para pacientes con EII concomitante, antes de la visita inicial deben estar disponibles los resultados de una colonoscopia realizada en los últimos 12 meses:
    • Los pacientes con enfermedad de Crohn (EC) deben estar en fase de remisión, según lo definido en el Índice de Actividad de la Enfermedad de Crohn (CDAI) < 150,
    • Los pacientes con colitis ulcerosa (CU) deben estar en fase de remisión o presentar una enfermedad leve, según lo definido en el Índice de Actividad Clínica (CAI) < 8.
    8. Las mujeres en edad fértil,es decir, las mujeres posmenárquicas fértiles, no esterilizadas, que no se encuentran aún en el período posmenopaúsico y que mantienen una actividad sexual deberán utilizar durante toda la fase de tratamiento y durante cuatro semanas después de la última toma del medicamento del estudio un método anticonceptivo altamente eficaz (es decir, menos del 1% anual) con una baja tasa de fallos si se utiliza de forma constante y correctamente, como anticonceptivos hormonales combinados (con estrógenos y gestágenos para administración oral, intravaginal o transdérmica) que inhiben la ovulación, anticonceptivos gestágenos puros (orales, inyectables o implantables) que inhiben la ovulación, dispositivos intrauterinos, sistemas intrauterinos (espiral hormonal), ligadura bilateral de trompa, vasectomía de la pareja o abstinencia sexual (solo se acepta como método anticonceptivo altamente eficaz si se corresponde con los hábitos y preferencias de la paciente). En el caso de que se utilicen métodos hormonales distintos de los implantes/espirales que contengan levonorgestrel o inyecciones de medroxiprogesterona, la pareja deberá usar además un preservativo.. Las mujeres no fértiles pueden participar, si se han esterilizado quirúrgicamente o son posmenopáusicas desde hace al menos 2 años. El investigador será responsable de determinar si la paciente dispone de un método anticonceptivo adecuado para la participación en el ensayo.
    E.4Principal exclusion criteria
    1. History or presence of other concomitant liver diseases including.
    4. Secondary causes of Sclerosing Cholangitis
    11. Total bilirubin > 4.0 mg/dL (> 68 μmol/L) at screening or baseline.
    13.Any known relevant infectious disease (e.g., active tuberculosis, AIDS defining diseases).
    14.Abnormal renal function
    15. Thyroid-stimulating hormone (TSH) > ULN at screening (elevated levels [4.2-10 μU/mL] are acceptable if fT4 is measured and within the normal range).
    16. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or on the interpretation of the results, or patient with atrial fibrillation or any disorder which in the opinion of the investigator may affect the patient's safety.
    17.Any active malignant disease.
    18.Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile.
    19.Well-founded doubt about the patient's cooperation.
    20.Existing or intended pregnancy or breast-feeding.
    21.Participation in another clinical trial within the last 30 days prior to screening visit.
    22.Patients who have an absolute contraindication for liver biopsy.
    23.Imprisoned persons, persons admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent (e.g. due to mental impairment).
    Antecedentes o presencia de otras enfermedades hepáticas concomitantes, incluidas:
    • Serología positiva de hepatitis B o C (HBs Ag+, anti-HBc+, anti-HCV+; Nota: Los pacientes que solo presenten anti-HBc+ se pueden incluir si son ADN VHB negativos);
    • Colangitis biliar primaria (titulación positiva de anticuerpos antimitocondriales [AAM]);
    • Enfermedad de Wilson;
    • Hemocromatosis;
    • Hepatitis autoinmune;
    • Consumo crónico de alcohol (consumo diario > 30 g/d),
    • Esteatohepatitis no alcohólica (NASH) demostrada mediante biopsia;
    • Colangiocarcinoma.
    2. Tratamiento con cualquiera de los fármacos siguientes durante los 3 meses anteriores al inicio del ensayo: cualquier glucocorticoide (incluida budesonida) si no es por inhalación, azatioprina u otros fármacos inmunosupresores (p. ej., ciclofosfamida, ciclosporina, metotrexato, tacrolimus, 6-mercaptopurina), clorambucilo, pentoxifilina, penicilamina, pirfenidona, biológicos (p. ej., tratamiento con antifactor de necrosis tumoral , antagonistas de la integrina [vedolizumab]) o rifampicina.
    3. Cambio de dosis durante los 6 meses previos al inicio del tratamiento concomitante con vitamina D o fibratos, si procede.
    4. Causas secundarias de la colangitis esclerosante (lesión iatrogénica del conducto biliar, colangitis asociada a IgG4 [aumento de la IgG4 > 4 x LSN], sepsis y quemaduras).
    5. Colangitis de pequeños conductos en ausencia de patología de los conductos grandes.
    6. Cirrosis hepática con clasificación de Child ≥ 9 puntos o antecedentes o presencia de descompensación hepática (p. ej., hemorragia varicosa).
    7. Encefalopatía hepática o ascitis mal controlada.
    8. Tratamiento endoscópico de la estenosis del conducto biliar necesario o programado en los 5 meses posteriores a la fecha de aleatorización de este ensayo.
    9. Antecedentes de sepsis biliar con hospitalización en los 3 meses anteriores al inicio del ensayo.
    10. Episodio actual de colangitis supurativa.
    11. Bilirrubina total > 4,0 mg/dl (> 68 μmol/l) en la visita exploratoria o inicial.
    12. EII que requirió tratamiento específico en los 3 meses anteriores al inicio del ensayo, excepto terapia de mantenimiento con ácido 5-aminosalicílico (5-AAS, mesalazina, mesalamina), compuestos de 5-AAS (sulfasalazina, osalazina, balsalazida) o probióticos.
    13. Cualquier enfermedad infecciosa relevante y conocida (p. ej., tuberculosis activa, enfermedades definidoras de SIDA).
    14. Función renal anómala (tasa de filtración glomerular calculada a partir de cistatina C < 30 ml/min) en la visita exploratoria o inicial.
    15. Hormona estimulante de la tiroides (TSH) > LSN en la visita exploratoria (se aceptará un nivel mayor [4,2-10 μU/ml] si se mide la T4 libre y este valor se sitúa dentro del intervalo normal).
    16. Cualquier trastorno grave cardiovascular, renal, endocrino o psiquiátrico concomitante que, en opinión del investigador, podría influir en la colaboración del paciente o en la interpretación de los resultados; paciente con fibrilación auricular y cualquier enfermedad que, en opinión del investigador, pueda poner en peligro la seguridad del paciente.
    17. Cualquier enfermedad maligna.
    18. Intolerancia/hipersensibilidad conocida al fármaco del ensayo o a fármacosde estructura química o perfil farmacológico similar.
    19. Dudas fundadas sobre la colaboración del paciente, p. ej., debido a una adicción al alcohol o a las drogas.
    20. Embarazo existente o previsto o lactancia.
    21. Participación en otro ensayo clínico en los 30 días previos a la visita exploratoria, participación simultánea en otro ensayo clínico o aleatorización previa en este ensayo y toma del medicamento en investigación (MEI) durante este ensayo.
    22. Pacientes con una contraindicación absoluta para la biopsia hepática.
    23. Presos, personas ingresadas en centros asistenciales, personas bajo tutela y presonas con incapacidad para otorgar el consentimiento (p. ej., debido a un trastorno mental).
    E.5 End points
    E.5.1Primary end point(s)
    Partial normalization of s-ALP and no worsening of disease stage.
    Normalización parcial de s-ALP y sin empeoramiento de la etapa de la enfermedad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2 and Visit 14
    Visita 2 y visita 14
    E.5.2Secondary end point(s)
    Secondary endpoints with regard to liver stiffness, fibrosis stage, liver histology, s-ALP levels, dominant strictures, quality of life
    Criterios de valoración secundarios con respecto a la rigidez hepática, etapa de fibrosis, histología hepática, niveles de s-ALP, estenosis dominantes, calidad de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 96
    semana 96
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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
    last visit of the last subject
    última visita último paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 50
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 210
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    For all patients, treatment decisions after study end (after V22, or in case of premature withdrawal during DB phase: after V14) are at the discretion of the respective investigator.
    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 Decision2020-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2026-03-26
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