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    Summary
    EudraCT Number:2013-005373-43
    Sponsor's Protocol Code Number:LUM001-304
    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:2014-05-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-005373-43
    A.3Full title of the trial
    Long-Term, Open-Label Study with a Double-Blind, Placebo Controlled, Randomized Drug Withdrawal Period of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Alagille Syndrome
    Estudio Abierto y a Largo Plazo Con un Periodo de Retirada Farmacológica Aleatorizado, Controlado con Placebo y Doble Ciego de LUM001, un Inhibidor del Transportador Apical de Ácidos Biliares Dependiente de Sodio (ASBTi), en Pacientes con Síndrome de Alagille
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to evaluate a drug (LUM001) that may help treat the liver and control itching in Alagille Syndrome. In this study, all children who are eligible to enrol will take study drug for 18 weeks, followed by a 4 week period where they will either take LUM001 or placebo. After this 4 week period, all patients will go back on active study drug treatment for the remaining 26 weeks.
    Elproposito de este estudio es evaluar el medicamento (LUM001) que podría ayudar a tratar el hígado y controlar el picor en el Síndrome Alagille. En este estudio todos los niños que sean aptos para ser incluidos, tomarán la medicación del estudio durante semanas, seguido de un periodo de 4 semanas donde cada uno tomará el medicamento LUM001 o placebo. Despues de este periodo de 4 semanas, los pacientes volverá al tratamiento con el medicamento activo del estudio durante las 26 semanas restantes
    A.3.2Name or abbreviated title of the trial where available
    ICONIC
    A.4.1Sponsor's protocol code numberLUM001-304
    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 SponsorLumena 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 supportLumena Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLumena Pharmaceuticals Inc
    B.5.2Functional name of contact pointChief Operating Officer
    B.5.3 Address:
    B.5.3.1Street Address12531 High Bluff Drive, Suite 110
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34917080386
    B.5.5Fax number++1858461 4888
    B.5.6E-mailinfo@lumenapharma.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/3/13/1214
    D.3 Description of the IMP
    D.3.1Product nameLUM001
    D.3.2Product code LUM001
    D.3.4Pharmaceutical form Powder and solvent for oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNLUM001
    D.3.9.1CAS number 228113-66-4
    D.3.9.2Current sponsor codeLUM001
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.05 to 60
    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 placeboOral solution
    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
    Alagille Syndrome
    Síndrome de Alagille
    E.1.1.1Medical condition in easily understood language
    Alagille Syndrome
    Síndrome de Alagille
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10053870
    E.1.2Term Alagille syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are:
    ?To evaluate the long-term safety and tolerability of LUM001 in children with ALGS.
    ?To evaluate the effect of LUM001 on serum bile acid levels in children with ALGS.
    ?To evaluate the effect of LUM001 on biochemical markers of cholestasis and liver disease in children with ALGS.
    ?To evaluate the effect of LUM001 on pruritus in children with ALGS.
    ?To evaluate the long-term durability of effect of LUM001 in children with ALGS during 48-weeks of treatment.
    ?Evaluar la seguridad y tolerabilidad a largo plazo de LUM001 en niños con SA
    ?Evaluar el efecto de LUM001 en los niveles séricos de ácidos biliares en niños con SA.
    ?Evaluar el efecto de LUM001 en los marcadores bioquímicos de colestasis y hepatopatía en niños con SA.
    ?Evaluar el efecto de LUM001 en el prurito en niños con SA.
    ?Evaluar la durabilidad a largo plazo del efecto de LUM001 en niños con SA tras 48 semanas de tratamiento.
    ? .
    E.2.2Secondary objectives of the trial
    Not applicable
    No Aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To participate in this study subjects must meet all of the following criteria:
    1.Male or female between the ages of 12 months and 18 years inclusive.
    2.Diagnosis of ALGS .
    3.Evidence of cholestasis (one or more of the following):
    a.Total serum bile acid > 3x ULN for age.
    b.Conjugated bilirubin > 1 mg/dL.
    c.Fat soluble vitamin deficiency otherwise unexplainable.
    d.GGT > 3x ULN for age.
    e.Intractable pruritus explainable only by liver disease.
    4.Females of childbearing potential must have a negative serum pregnancy test during Screening.
    5.Sexually active females must be prepared to use an effective method of contraception during the trial, such as:
    a.Hormonal (e.g., contraceptive pill, patch, intramuscular implant or injection).
    b.Barrier method, i.e., (a) condom (male or female) or (b) diaphragm, with spermicide.
    c.Intrauterine device (IUD).
    6.Subject is expected to have a consistent caregiver(s) for the duration of the study.
    7.Informed consent and assent (per IRB/IEC) as appropriate.
    8.Access to phone for scheduled calls from study site.
    9.Caregivers (and age appropriate subjects) must be willing and able to use an eDiary device during the study.
    10.Caregivers (and age appropriate subjects) must digitally accept the licensing agreement in the eDiary software.
    11.Caregivers (and age appropriate subjects) must complete at least 10 eDiary reports (morning or evening) during each of two consecutive weeks of the screening period (maximum possible reports = 14 per week).
    12.Average daily score >2 on the Itch Reported Outcome (ItchRO?) questionnaire (maximum possible daily score of 4) for two consecutive weeks in the screening period, prior to dosing. A daily score is the higher of the scores for the morning and evening ItchRO. The average daily score is the sum of all daily scores divided by the number of days the ItchRO was completed.
    1.Varones o mujeres de edades comprendidas entre los 12 meses y los 18 años, inclusive.
    2.Pacientes con diagnóstico de SA en función de los criterios de diagnóstico descritos en el Apartado 16.3.
    3.Signos de colestasis (uno o más de los siguientes):
    a.Niveles séricos totales de ácidos biliares > 3 veces el LSN para su edad.
    b.Bilirrubina conjugada > 1 mg/dl.
    c.Deficiencia de vitaminas liposolubles, inexplicable de otra forma.
    d.GGT > 3 veces el LSN para su edad.
    e.Prurito resistente al tratamiento, inexplicable únicamente por la hepatopatía.
    4.Las mujeres en edad fértil deben dar negativo en una prueba de embarazo en suero durante la selección.
    5.Las mujeres sexualmente activas deben estar dispuestas a utilizar un método anticonceptivo eficaz durante el estudio, como:
    a.Método anticonceptivo hormonal (p. ej., píldora anticonceptiva, parche o implante o inyección intramuscular).
    b.Método de barrera, p ej., (a) preservativo (masculino o femenino) o (b) diafragma, con espermicida.
    c.Dispositivo intrauterino (DIU).
    6.Se espera que el paciente cuente con un cuidador constante durante todo el estudio.
    7.Consentimiento y asentimiento informado (según el CEIC), según el caso.
    8.Acceso a un teléfono para recibir las llamadas telefónicas programadas del centro del estudio.
    9.Los cuidadores (y los pacientes con una edad apropiada) deben demostrar su capacidad y disposición para utilizar un diario electrónico durante el estudio.
    10.Los cuidadores (y los pacientes con una edad apropiada) deberán aceptar de forma digital el acuerdo de licencia en el software del diario electrónico.
    11.Los cuidadores (y los pacientes con una edad apropiada) deberán realizar al menos 10 informes en el diario electrónico (por la mañana o por la noche) durante las dos semanas consecutivas del periodo de selección (informes máximos posibles = 14 a la semana).
    12.Puntuación diaria media > 2 en el cuestionario de resultados notificados sobre el prurito (Itch Reported Outcome, ItchRO?) (puntuación diaria máxima posible = 4) durante dos semanas consecutivas en el periodo de selección, antes de la administración del fármaco. Una puntuación diaria es la puntuación máxima alcanzada por la mañana o por la noche en el cuestionario ItchRO. La puntuación diaria media es la suma de todas las puntuaciones diarias dividida entre el número de días en los que se haya cumplimentado el cuestionario ItchRO.
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if they meet any of the following criteria:
    1.Chronic diarrhea requiring ongoing intravenous fluid or nutritional intervention.
    2.Surgical interruption of the enterohepatic circulation.
    3.Previous liver transplant.
    4.Decompensated cirrhosis [ALT >15 x ULN, INR >1.5 (unresponsive to vitamin K therapy), albumin < 3.0 gm/dL, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy].
    5.History or presence of other concomitant liver disease.
    6.History or presence of any other disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, including bile salt metabolism in the intestine (e.g., inflammatory bowel disease).
    7.Known diagnosis of human immunodeficiency virus (HIV) infection.
    8.Cancers except for in situ carcinoma, or cancers treated at least 5 years prior to Screening with no evidence of recurrence.
    9.Recent medical history, or current status that suggests that the subject may be unable to complete the study.
    10.Any female who is pregnant or lactating or who is planning to become pregnant during the study period.
    11.Known history of alcohol or substance abuse.
    12.Administration of bile acid or lipid binding resins within 28 days prior to screening and throughout the trial.
    13.Receipt of investigational drug, biologic, or medical device within 28 days prior to Screening, or 5 half-lives of the study agent, whichever is longer.
    14.History of non-adherence to medical regimens, unreliability, mental instability or incompetence that could compromise the validity of informed consent or lead to non-adherence with the study protocol based upon Investigator judgment.
    15.Any other conditions or abnormalities which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the subject, or interfere with the subject participating in or completing the study.
    Se excluirá del estudio a los pacientes si cumplen alguno de los criterios siguientes:
    1.Diarrea crónica que requiere la administración continuada de líquidos o intervención nutricional.
    2.Interrupción quirúrgica de la circulación enterohepática.
    3.Trasplante hepático previo.
    4.Cirrosis descompensada (ALT > 15 veces el LSN, INR > 1,5 [ausencia de respuesta al tratamiento con vitamina K], albúmina < 3,0 g/dl, antecedentes o presencia de ascitis clínicamente significativa, hemorragia varicosa y/o encefalopatía).
    5.Antecedentes o presencia de otra hepatopatía concomitante.
    6.Antecedentes o presencia de cualquier otra enfermedad o patología que interfiera en la absorción, distribución, metabolismo o eliminación de los fármacos, incluido el metabolismo de las sales biliares en el intestino (p. ej., enfermedad inflamatoria intestinal).
    7.Diagnóstico de infección por el virus de la inmunodeficiencia humana (VIH).
    8.Neoplasias malignas, excepto carcinoma in situ, o neoplasias malignas tratadas como mínimo 5 años antes de la selección, sin signos de recidiva.
    9.Antecedentes médicos recientes o estado actual que indique que el paciente puede no ser capaz de completar el estudio.
    10.Mujeres embarazadas o en periodo de lactancia o que tengan previsto quedarse embarazadas durante el periodo del estudio.
    11.Antecedentes conocidos de alcoholismo o drogadicción.
    12.Administración de resinas quelantes de ácidos biliares o de lípidos en los 28 días previos a la selección y durante el estudio.
    13.Administración del fármaco en investigación, biofármaco o producto sanitario en los 28 días previos a la selección o 5 semividas del agente del estudio, lo que sea mayor.
    14.Antecedentes de incumplimiento de pautas de tratamiento, falta de fiabilidad, inestabilidad o incapacidad mental que podrían poner en peligro la validez del consentimiento informado o dar lugar a falta de cumplimiento del protocolo del estudio en opinión del investigador.
    15.Cualquier otra enfermedad o alteración que, en opinión del investigador o del monitor médico, podría comprometer la seguridad del paciente o interferir en la participación del paciente o en la realización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the mean change in serum bile acid levels from Week 18 to Week 22 for those who responded to LUM001 treatment, which is defined as subjects who had a >50% reduction in serum bile acid levels from baseline to Week 18.
    La variable primaria de eficacia seá la media del cambio en los niveles séricos de ácidos biliares desde la semana 18 a la 22 para aquellos que respondieron al tratamiento con LUM001, los cuales se definen como sujetos que tuvieron más de 50% de reducción en los niveles séricos de ácidos biliares desde la visita basal a la semana 18.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Serum bile acid levels are measured at baseline, 12, 18, 22 and 48 weeks
    Los niveles séricos de ácidos biliares son medidos en las visitas, basal, en las semanas 12,18,22 y 48
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include mean change from Week 18 to Week 22 in liver enzymes (ALP, ALT, and bilirubin (total and direct)) and pruritus as measured by ItchRO (Observer ItchRO/patient ItchRO). Secondary efficacy endpoints also include mean change from baseline to Week 18 in serum bile acid level, liver enzymes (ALP, ALT, and bilirubin (total and direct)) and pruritus as measured by ItchRO (Observer ItchRO/Patient ItchRO)
    Las variablaes secundarias de eficacia, incluyen la media del cambio desde la semana 18 a la semana 22 en las enzimas hepáticas (ALP, ALT y bilirrubina total y directa) y prurito medido a través de la escala ItchRO (Observer ItchRO/patient ItchRO). La variables secundarias de eficacia además incluyen la media del cambio desde la vista basal a la semana 18 en los niveles séricos de ácidos biliares, de enzimas hepáticas (ALP, ALT y bilirrubina total y directa) y prurito medido a través de la escala ItchRO (Observer ItchRO/patient ItchRO)
    E.5.2.1Timepoint(s) of evaluation of this end point
    These are measured throughout the trial by means of the subject eDiary and clinician scales and questionnaires.
    Estas variables son medidas a lo largo del ensayo a través de las medias de los diarios electrónicos de los pacientes y las escalas y cuestionarios clínicos.
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    This trial also contains a double blind drug withdrawal period
    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 EEA5
    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
    Australia
    Canada
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children from 1-18 yrs are to be recruited. Assent and parent/cargiver consent will be obtained for those children not able to provide assent personally.
    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 18
    F.4.2.2In the whole clinical trial 30
    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)
    The patients will return to their standard care with their own physician following completion of the trial
    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 Decision2014-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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